OnCore Super User Training

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OnCore Super User Training | Manualzz

OnCore Super User Training

for Washington University in St. Louis

April 2015

WUSTL Super User Training Agenda

April 27-28, 2015

Start Time End Time

8:00

8:30

9:30

11:00

11:45

12:45

2:15

3:30

8:30

9:30

11:45

12:45

2:15

5:00

Start Time End Time

8:00 8:30

8:30 9:00

9:00

10:45

12:15

1:15

2:15

3:30

5:00

11:00

3:30

5:00

10:45

12:15

1:15

2:15

3:30

5:00

Day 1

Arrive and Settle In, Introductions

OnCore Demo and Overview

Demo, Terminology, Navigation, Architecture

Protocol Creation and Set Up

Main Protocol Details, Protocol Documents, Reviews, Consent Forms, Participating

Institutions, Opening a Protocol to Accrual

ePRMS Demo

Lunch

Protocol Calendar

Introduction to Specifications, Labs/Panels/Procedures, Scheduling

OnCore Forms Administration

Building eCRFs

Reports and Searches

Protocol Search, Document Search, Reports, Accrual Monitoring, Home Page Customization,

Widgets

Adjourn

DAY 2

Arrive and Settle In

Recap of Previous Day

Financials

Charge Master, Coverage Analysis, Pre-Award Budgets

Subject Administration

Subject Registration, Demographics, Consent, Eligibility, On Study, On Treatment, On

Follow-up/Off Study, SAEs, Deviations, Pre-Screening

Lunch

Subject Calendars

Visit Tracking, Subject Form Data Entry, DM Console, Biostat Console

Financials

Sponsor Invoicing, Receipts

Additional Consoles

Subject Search, My Console, DSMC Console, Team Console, Effort Tracking

Adjourn

OnCore Navigation

The toolbar at the top of every page provides quick links to OnCore tools, as well as information about the current user.

The name of the current user is displayed at the top of the home screen.

The access role determines the tools, pages, and information available in

OnCore. Access roles are lists of privileges that determine your permissions: the protocol and subject information you can view and edit.

Every OnCore user is associated with an Institution. You have access to protocols and subjects only at your institution.

The main Menu Bar appears under the header. It contains menus and menu items that you have permission to see (such as the PC Console).

The Home link returns you to the home screen from anywhere in OnCore.

The gear icon opens the Home Screen Configuration page, allowing you to select widgets that provide quick access to your protocols, subjects, saved searches, recently-run reports, or other frequently-used tools.

My Profile allows you to set the default access role, choose an OnCore color scheme, and reset your password.

Clicking Help displays a drop-down list of online help links and information about your version of

OnCore

OnCore Navigation | Page 1 of 12

Access Roles

Instead of creating several access roles that only apply only to a few users, administrators typically build a set of common roles that can be assigned to users as needed. Users that have been assigned multiple roles can select one of those roles by clicking the arrow next to the current role at the top of OnCore:

NOTE: You can only be in one access role at a time. To use permissions granted by a different access role, you can switch between any of your assigned roles at any time while you are logged into OnCore.

Navigating in OnCore

Menus and menu items

Many of the features of OnCore can be viewed in the PC Console. To open the PC

Console, hover your cursor over the Protocols menu. A list of menu items appear; select the PC Console menu item.

Visit the OnCore Learning Portal at http://docs.onsemble.net

OnCore Navigation | Page 2 of 12

In OnCore, the action of moving through several options to reach a desired location is called navigation. For convenience, navigation through several areas of a function is often described in a path, such as Subjects > Subject Console.

In the above example, selecting PC Console from the Protocols menu would be abbreviated in the following phrase: “Navigate to Protocols > PC Console.”

Consoles

OnCore contains several consoles. A console is a set of related pages for a particular workflow, function, or type of data. For example, the PC Console displays information about one protocol at a time: details that might be of interest to a

Protocol Coordinator. The PC Console includes the protocol number and title, the type of study, the staff assigned to the protocol, the protocol sponsor, and other protocol-related information.

In the same way, the Subject Console displays information about a selected subject. It also provides tools where you can update the subject’s demographic information, document the subject’s consent, or view the subject’s calendar.

To explore the elements of a console:

1.

Navigate to Protocols > PC Console.

The PC Console opens, allowing you to select a protocol.

OnCore Navigation | Page 3 of 12

2.

All protocols in OnCore are identified by an alphanumeric protocol number.

Select a protocol by entering the protocol number in the Select Protocol field.

Find-as-you-type fields

The Select Protocol field is a find-as-you-type field. Typing an entry in this field prompts OnCore to immediately display a list of potential protocols as soon as it matches a part of your entry. This field may be used to help you locate your protocol by limiting the number of potential matches.

For example, if you type “12” in this field, OnCore will immediately display a scrolling list of all protocols containing 12 as part of its protocol number.

1.

Select any protocol from the drop-down list attached to the Select Protocol field.

The protocol and its associated information will display in the PC Console.

Console header

The console header provides at-a-glance information about the selected record

(such as the protocol, subject, or calendar, etc.,) within any console in OnCore. In the example below, the PC Console shows the protocol number, sponsor, principal investigator(s), status, and accrual information for a particular protocol.

Visit the OnCore Learning Portal at http://docs.onsemble.net

OnCore Navigation | Page 4 of 12

Vertical tabs

Along the left side of the PC Console is a column of vertical tabs. Each vertical tab allows to you enter and view information specific to the area described by the tab.

For example, the Treatment tab allows you to configure the protocol’s treatment steps and arms.

Horizontal tabs

Some vertical tabs in OnCore are further organized into horizontal tabs. Horizontal tabs allow for easy navigation between subsets of the information contained on the selected vertical tab.

OnCore Navigation | Page 5 of 12

In the example below, the Main vertical tab contains an additional 6 horizontal tabs:

Details, Management, Staff, Sponsor, IND/IDE, and Clinical/Trials.gov/CTRP.

A quick way to access the horizontal tabs is to click on the >> on a selected vertical tab, which will display a drop-down list of options identical to the horizontal tabs.

Simply selecting the option from the drop-down list will permit you to navigate directly to one of the displayed horizontal tabs.

Read-only mode vs. update mode

Many pages in OnCore can be viewed in read-only mode or in update mode. In

read-only mode, you can view data but you cannot make modifications to it. In

update mode, the fields on the page become editable, and radio buttons and checkboxes become selectable, allowing you to make modifications to the data.

The ability to view or update data in OnCore is controlled by assigned privileges. In most cases, one privilege will grant read-only access to a screen in OnCore, and an

additional privilege must be granted in order to update data on that screen.

If you have the privilege to update information on a screen in OnCore, an update button will appear in the lower-right corner of the page. In update mode, you can edit data in text fields, select different values from the drop-down menus, and select or deselect options on a page.

Visit the OnCore Learning Portal at http://docs.onsemble.net

OnCore Navigation | Page 6 of 12

Once you are in update mode, several additional buttons display at the bottom of the page. These buttons typically include the Submit, Clear, and Close buttons.

Submit

Saves the data entered on the page; the page remains in update mode.

Clear

Restores all fields to their most recently saved values; it does not erase all data on the page.

Close

Returns the page to inquiry mode; any unsaved data will be discarded.

Add blocks

Some OnCore pages contain add blocks, which are sections on the page that allow you to update a subset of the currently-displayed data. Add blocks contain their own set of New, Update, Clear, Close, and Submit buttons.

In the example that follows, after selecting a role and a staff person, you must click

Add to assign the staff member to a protocol:

OnCore Navigation | Page 7 of 12

The Clear and Close buttons on the Staff tab are specific to this add block; you may click Clear to remove the selections or click Close to return to inquiry mode on the

Staff tab.

Date widgets

Fields that have the date icon to the right of the field display date widgets.

Clicking on the date icon launches the date widget, where you may select your date from the displayed calendar.

Visit the OnCore Learning Portal at http://docs.onsemble.net

OnCore Navigation | Page 8 of 12

Date widget and keyboard shortcuts

OnCore accepts dates in a number of formats, including 1 or 2-digit months and days and 2 or 4-digit years. OnCore converts all entries into the MM/DD/YYYY date format. If you enter two-digit months and days, you may omit the slashes. Any of the following are acceptable:

 12/2/09 will become 12/2/2009

 4/6/88 will become 04/06/1988

09/01/1955 is accepted as-is

080810 will become 08/08/2010

Date fields in OnCore also accept a variety of keyboard shortcuts, or dates that are calculated relative to another date, as opposed to a specific date.

Shortcut Resulting entry t

Inserts the current date

t + n

t - n

(where n is a number)

Inserts a date n days from today: t +3 is three days from today t-1 inserts yesterday’s date (1 day ago)

w – n

w + n

Inserts the current date plus/minus n number of weeks w – 6 will insert a date 6 weeks ago w + 2 will insert a date 2 weeks from today

Inserts the current date plus/minus n number of months

m + n

m – n

y + n

y – n

mb or me

Inserts the current date plus/minus n number of years

yb or ye

Inserts the beginning or end of the month respectively; it may be used alone, or with + or – with a number

Inserts the beginning or end of the year, respectively; it may be used alone or with + or – with a number

OnCore Navigation | Page 9 of 12

NOTE: When entering a keyboard shortcut into a date widget field, you may press

Enter, Tab, or click anywhere outside the date widget to calculate the appropriate date in MM/DD/YYYY format.

Test your knowledge: How many different ways could you enter January 1st, 2015, into a date widget in OnCore?

Visit the OnCore Learning Portal at http://docs.onsemble.net

OnCore Navigation | Page 10 of 12

Tips for Using OnCore Successfully

Use Only One Instance of OnCore at a Time

Only one session (browser window or browser tab) of OnCore should be open at a time on a single system. Multiple sessions of OnCore could result in duplicate data and application misbehavior.

Avoid Using the Browser’s Back Button

Avoid using the browser’s Back button while working in OnCore; instead, use

OnCore’s buttons, tabs, and menus to navigate within the program. Using the browser toolbar to navigate may lead to unexpected results, such as unsaved data or webpage errors.

Allow Popup Blockers for OnCore

OnCore uses many pop-up (browse) windows that allow you to make selections and enter data. If your browser is set to prevent pop-up windows from displaying, it will also prevent OnCore’s browse windows from displaying.

You must allow pop-up windows to display in each browser that you are using with

OnCore. See the examples that follow to learn how to allow pop-up windows in

Chrome, Firefox, and Internet Explorer:

 To allow pop-up windows in Chrome, select the following option:

OnCore Navigation | Page 11 of 12

 To allow pop-up windows in Firefox, select the following option:

 To allow pop-up windows in Internet Explorer, select the following option:

Visit the OnCore Learning Portal at http://docs.onsemble.net

OnCore Navigation | Page 12 of 12

Protocol Creation and Setup

Protocol Creation and Setup

Protocols are the foundation of all OnCore functionality and features. Protocol information must be entered in OnCore before building calendars, creating a protocol budget, enrolling subjects, tracking subject visits, or invoicing sponsors.

The PC Console (Protocol Coordinator Console) is the central repository for protocol information. Protocol coordinators track protocol ID numbers, objectives, assigned staff, sponsors, participating institutions, regulatory information, investigational drug, and device information, and other details of each research study.

Protocol Creation and Setup | Page 1 of 35

Create a new protocol in the PC Console

1.

Navigate to Protocols > PC Console.

The PC Console is used to view and update protocol information. The PC

Console is organized by vertical tabs on the left such as Treatment,

Institutions, and Status.

Above the vertical tabs is the Select Protocol field, a find-as-you-type field used to locate Protocols in OnCore. Find an existing study by searching for any of the following identifiers:

 Protocol ID

 IRB No.

 Pharmacy No.

 SRC (Scientific Review Committee) No.

 Sponsor No.

 NCT ID.

2.

Click New Protocol.

New Protocol is the last vertical tab on the left.

NOTE: Protocol No., Library, Department, Organizational Unit, and Protocol

Type are required when creating a new protocol in OnCore.

Other fields might be required by OnCore depending on your configurations.

Additional protocol information might be required by your SOPs (standard operating procedures).

Visit the OnCore Learning Portal at http://docs.onsemble.net

Protocol Creation and Setup | Page 2 of 35

3.

Enter the following data:

Cardiology

Protocol No. : PROT-your initials

Library: Cardiology

Department: Cardiology

Organizational Unit: Medical School

Title: Training Protocol for your name

Short Title: Protocol for your name

Phase: Phase II

Scope: National

Age: Adults

Investigator Initiated Protocol: Yes

Summary Accrual Info Only: No

Protocol Type: Therapeutic

Protocol Target Accrual: 100

RC Total Accrual Goal (Upper): 70

Accrual Duration (Months): 16

Primary Completion Date: y+2

Select Anticipated radio button

Oncology

Protocol No. : PROT-your initials

Library: Oncology

Department: Oncology

Organizational Unit: Cancer Center

Title: Training Protocol for your name

Short Title: Protocol for your name

Phase: Phase II

Scope: National

Age: Adults

Investigator Initiated Protocol: Yes

Summary Accrual Info Only: No

Protocol Type: Treatment

Data Table 4 Report Type

DT4

*

:

Interventional

Protocol Target Accrual: 100

RC Total Accrual Goal (Upper): 70

Accrual Duration (Months): 16

Primary Completion Date: y+2

Select Anticipated radio button

Protocol Creation and Setup | Page 3 of 35

4.

Click Submit.

Verify that your protocol number appears in the header of the PC Console.

Notice that your study has a Protocol Status of New.

Track additional study IDs and management details

Protocols in OnCore often have multiple IDs; one study might have a Sponsor

Protocol No., a Pharmacy No., an IRB No., an NCT ID, and others. OnCore stores multiple protocol numbers for each study and allows users to look up protocols by any of the identifiers.

1.

Navigate to Main > Management.

2.

Enter additional identifiers for the protocol.

IRB No.: IRB-XYZ (where XYZ are your initials)

Pharmacy No.: PA03-XYZ (where XYZ are your initials)

Remember that the additional IDs entered on the Management tab can be used to search for protocols in OnCore.

3.

Choose a Coding Scheme for adverse events (AEs and SAEs) documented for subjects on this protocol. For example:

Coding Scheme: CTCAE v4.0

IMPORTANT

The Coding Scheme cannot be changed once an adverse event has been documented for a subject on this protocol.

The only exception is changing from CTCAE v3.0 to CTCAE v4.0 because a mapping exists in OnCore so existing AEs and SAEs can be upgraded appropriately.

Visit the OnCore Learning Portal at http://docs.onsemble.net

Protocol Creation and Setup | Page 4 of 35

4.

Optional: to automatically generate MRNs and sequence numbers for subjects on this protocol, do the following:

 Set the Automated Sequence No. field to Yes

 Click Edit to configure the sequence numbers to have a prefix of XYZ

(where XYZ are your initials) and a starting number of 100.

5.

Click Submit to save the study details.

Assign management groups to a protocol

1.

Assign this protocol to appropriate teams/groups in the

Administrative

Groups section of the Main > Management tab. Click Select, and add the appropriate groups:

Cardiology Oncology

Management Groups

 Select the checkboxes for

Cardiovascular and Nutrition, then click

Add.

Program Areas

 Select the checkbox for

Cancer Control, then click

Add.

Oncology Group

 Select the checkbox for Lung, then click Add.

Management Group

 Select the checkboxes for

Lung and Oncology, then click Add.

2.

Select the Primary checkbox for the appropriate Administrative Group(s).

3.

Click Submit to save the protocol details.

Protocol Creation and Setup | Page 5 of 35

Assign staff to a protocol individually

1.

Navigate to the PC Console > Main > Staff tab.

If you created this protocol in OnCore, you have been automatically added as a

Protocol Staff with a role of Protocol Creator.

2.

Add a Principal Investigator. For example, enter the following:

Role: Principal Investigator

Staff Name: Grace Arnold (if unavailable, choose any)

Start Date: t (date shortcut indicating today’s date)

3.

Click Add.

The selected staff record has been added to the protocol with a role of

Principal Investigator.

Assign staff to a protocol by selecting team members from another study

If staff members often work together on protocols, you can save time when assigning staff by copying staff assignments from another study.

1.

On the PC Console > Main > Staff tab, click Select Team.

2.

Search for another protocol, and then click Show Team. For example:

Protocol: CARD0815

3.

Select all staff members who should be assigned to your new protocol, then click Submit. For example:

 Click Select All to choose all staff members currently assigned to

CARD0815.

 Unselect Arnold, Grace (Principal Investigator) because she is already assigned to this protocol.

Visit the OnCore Learning Portal at http://docs.onsemble.net

Protocol Creation and Setup | Page 6 of 35

 Unselect Brown, Charles (Co-Investigator) because West Virginia is not participating on this study.

NOTE: You can click Edit next to any assigned staff person to add start/stop dates, change the institution to which they are assigned for this study, or delete any staff assignments added in error.

Add a sponsor to a protocol

Multiple sponsors can be assigned to a protocol, but only one can be the Principal

Sponsor. All sponsors can be invoiced for procedures or visits during this protocol.

The Principal Sponsor appears on the Data Table 4 Report and in the header of the

PC Console, Financials Console, and other OnCore tools.

1.

Navigate to the PC Console > Main > Sponsor tab.

2.

Click Add Sponsor.

3.

In the “ Search here for existing sponsor to add” field, find the sponsor(s) for this protocol, and then click Add. In a Forte training environment, select the following sponsors:

Parke-Davis

ECOG

4.

Select the Principal Sponsor checkbox to indicate that Parke-Davis is the

Primary Principal Sponsor.

5.

Enter a Sponsor Protocol No. of PD-02315 for the Principal Sponsor.

Remember that the sponsor protocol number can be used when searching for protocols.

Protocol Creation and Setup | Page 7 of 35

Tracking Treatment Details and Disease/Diagnosis

When you navigate to the PC Console > Treatment tab, you will see two horizontal tabs: Details and Disease/Diagnosis.

Details

Tracks the protocol’s steps, treatment arms, treatment levels, drugs, devices, and modalities

Disease/Diagnosis

Lists the subject conditions or diagnoses evaluated by this research study

A protocol’s treatment plan is organized into steps, arms, and levels. Each arm can be associated with drugs, devices, and/or modalities being studied through the data collected for subjects on that arm.

Step

Arm

A group of treatment arms (for organizational purposes only; does not drive any OnCore functionality). Choose Registration or Randomization as applicable to the protocol.

Within a step, one arm or multiple arms may be defined. Every protocol that has a clinical calendar requires at least one arm.

Modalities

The arm’s method of treatment, such as surgery or chemotherapy.

Drugs

The drugs (agents) being administered to subjects on the treatment arm. Adverse events can be attributed to drugs listed in the PC Console > Treatment tab.

Devices

Levels

The devices being used in the arm.

The dosage levels being tested. Usually used for Phase I trials when the maximum tolerable dose is being determined. If one arm has levels defined, all arms must have levels defined.

NOTE: A protocol must have at least one step and one treatment arm before a clinical calendar can be created for the study.

Visit the OnCore Learning Portal at http://docs.onsemble.net

Protocol Creation and Setup | Page 8 of 35

Enter the study’s treatment details

For your example protocol, subjects will be randomized to two arms (A and B).

Subjects on Arm A of this study will receive the active ingredient being investigated plus a stabilizing agent, which is thought to help increase absorption of the drug.

Subjects on Arm B will only receive the active ingredient.

1.

Navigate to the PC Console > Treatment > Details tab.

2.

Enter a Step Code of 1, verify that Randomization is selected, then click Add.

3.

Click Arms.

4.

Create the following treatment arms. After entering each arm’s code and description, click Add.

Code

ArmA

Description

Arm A – Drug plus stabilizer

ArmB Arm B – Drug only

5.

Click

Modalities/Drugs/Devices for Arm A.

6.

Add the appropriate Modality and Drugs for Arm A.

Non-Oncology Oncology

Modality: Surgery

Drugs: Cozaar; Endostatin

Modality: Chemotherapy

Drugs: Cisplatin; Interferon-alfa

7.

Click

Modalities/Drugs/Devices for Arm B.

Protocol Creation and Setup | Page 9 of 35

8.

Add the appropriate Modality and Drug for Arm B.

Non-Oncology Oncology

Modality: Surgery

Drug: Cozaar

Modality: Chemotherapy

Drug: Cisplatin

9.

Click Close three times to return to the Details page shown here:

Enter the disease/diagnosis

1.

Click the Disease/Diagnosis horizontal tab.

2.

Enter the protocol’s Diagnosis or Disease Site (the label Disease Site is used in the Oncology library only).

For protocols using a non-oncology library, Diagnosis values are reference codes in the Diagnosis domain.

For the Oncology library, the Disease Site values come from the Data Table 3

Disease Site list.

Visit the OnCore Learning Portal at http://docs.onsemble.net

Protocol Creation and Setup | Page 10 of 35

3.

Click Select to choose the Diagnoses or Disease Sites being studied on this protocol, click Update first if necessary:

Cardiology

Cardiac Disease

Heart

Oncology

Lung

Soft Tissue

4.

Click Add to save your selections.

Record Participating Institutions and Study Sites

In order to register subjects to a protocol, you must have at least one active study site at the Research Center or another participating institution. Institution participating is recorded on the PC Console > Institutions tab.

Add participating institutions

1.

Navigate to the PC Console > Institution tab, and click Update if necessary.

No institutions are added to new protocols automatically. The Research Center and any participating affiliates or consortium members must be added here.

2.

Click Add, and then click the magnifying glass icon to see a list of institutions.

3.

Click the Outstanding Research Center, then click Save.

4.

Click Add again, and then click the magnifying glass icon.

5.

Add the institution called City of Hope.

6.

Select the checkbox to indicate that City of Hope Uses Research Center IRB?

Note to Oncology users

This checkbox is labeled

Uses

Cancer Center IRB? when

OnCore is configured as a

Cancer Center.

Protocol Creation and Setup | Page 11 of 35

7.

Click Save.

8.

Add the institution called Unity Health. This time, do not select the Uses

Research Center IRB? checkbox.

9.

Click Save.

Update study site participation

Beneath each Participating Institution you will see a bulleted list of participating study sites.

In this example protocol, the Wisconsin Cancer

Group site does not have the required resources for this protocol, so no subjects will be accrued to that site. The following instructions show you how to indicate that the Wisconsin Cancer Group (one of the study sites under City of Hope) is not participating on this protocol:

Good to know

Your OnCore administrator can configure the default setting

(selected or unselected) for each institution’s study site.

These defaults can be overridden per protocol by using the instructions in this section.

1.

From the PC Console > Institution tab, click City of Hope to open the

Protocol Institution Console.

The Protocol Institution pages allow you to track reviews, checklists, documents, and regulatory items specific to City of Hope.

2.

Click the Study Sites tab, and click Update if necessary.

3.

Unselect the checkbox for the Wisconsin Cancer Group, and then click

Submit.

This indicates that the Wisconsin Cancer Group site will not be available for subject registration for this protocol.

4.

Click the PC Console vertical tab to return to the PC Console > Institution tab.

Visit the OnCore Learning Portal at http://docs.onsemble.net

Protocol Creation and Setup | Page 12 of 35

Documenting Committee Reviews

Protocols have a status of NEW until the first committee review is documented for the study (either an IRB or SRC review). The current protocol status appears in the

PC Console header; a history of the protocol’s status changes can be seen in the

Status tab.

All protocols in OnCore must have an IRB review documented before opening to accrual. Other committee reviews might be required by your organization but they are not required by the application – they can be tracked in OnCore for informational purposes, and OnCore can send a notification to appropriate staff members when an IRB or SRC review is about to expire.

Document an IRB review at the Research Center

The following instructions show you how to record the Research Center’s IRB information on the PC Console > Reviews > IRB tab.

NOTE: Affiliate IRB information (if the Affiliate is using its own IRB for the protocol) is recorded on the Protocol Institution > IRB Reviews tab.

1.

Navigate to PC Console > Reviews.

The Summary tab provides a read-only view of all Research Center committee reviews documented for this protocol.

If any of the participating affiliates use their own IRB committee, reviews for those institutions must be entered in the Institution Console.

2.

To document an IRB initial review for this protocol, click the IRB horizontal tab.

NOTE: The IRB review is the only review that is required by OnCore. Other reviews are optional, and the abbreviations which represent the scientific and safety committees are configurable; for example, you might see PRMC instead of SRC in your OnCore environment.

Protocol Creation and Setup | Page 13 of 35

3.

Click Add.

4.

Click the down arrow in the Review Date field.

All review dates entered for other protocols are listed in this field. This is because several studies are often reviewed at the same IRB meeting.

5.

Choose a review date for this protocol. For example:

 In the Review Date field, select 08/14/2014.

The field displays 50 dates at a time; you can type 2014 to filter the list.

NOTE: The Review Date field is unique in that it does not have "date widget" functionality. If a Review Date is not available, you can add a date using

MM/DD/YYYY format.

6.

Indicate that the review was submitted prior to the meeting. For example, enter:

Submit Date: 8/10/2014

7.

Choose the committee that reviewed this protocol. For example:

Committee: Central IRB

8.

Enter the type and reason for the review:

Review Reason: Initial Review

Review Type: Full

9.

Indicate the committee’s action and the review’s expiration:

Action: Approved

Action Date: 08/14/2014

Expiration Date: 08/15/2015

10.

Click Submit.

Visit the OnCore Learning Portal at http://docs.onsemble.net

Protocol Creation and Setup | Page 14 of 35

The Protocol Status in the PC Console header is now IRB INITIAL

APPROVAL.

Add a reviewed consent form

Supporting documents are often reviewed when a study is submitted to the IRB.

These documents can be uploaded to OnCore and attached to the IRB review at which they were approved. Approved consent forms appear in the Subject Console when registering new patients. The patient’s decision regarding each consent form

(consented or refused) is recorded by the study team.

1.

With an IRB review open, click

Add in the Details section.

2.

Choose the document Type of Treatment Consent.

3.

Indicate that the consent was submitted to the IRB with other protocol documentation and approved on the review’s Action Date. If you used the example dates in the previous instruction, enter the following:

Received Date: 8/10/2014

Version Date: 8/14/2014

4.

Type a brief description for this consent form, to help study team members distinguish between different versions in the future. For example:

Description: Tx Consent v1

5.

Click Save.

You can now attach a corresponding document within the review.

6.

To attach the consent document, click

File, then click Choose File. Select the document on your computer, and then click Submit.

Good to know

To indicate that a single consent document covers multiple types of consent (for example,

Treatment Consent, HIPAA

Consent, and Tissue Consent), click the Type link and select the appropriate checkboxes in the Detail Type Update window.

Protocol Creation and Setup | Page 15 of 35

7.

Select the Release checkbox, and then click Submit.

NOTE: Releasing a file makes it available for download (to users with the appropriate privileges) on the PC Console > Documents tab and in Protocols >

Document Search.

Include affiliate institution(s) on the Research Center’s

IRB review

City of Hope is a participating institution on this study. In the PC Console >

Institution tab, these IRB dates appear for the Outstanding Research Center but not for City of Hope, even though City of Hope has been configured to use the

Research Center IRB. An additional step is necessary to “pass along” the IRB decision and consent documents to the City of Hope affiliate institution:

1.

With the Research Center’s IRB review open in PC Console > Reviews, click

Edit to the right of the Institution field in the review:

Visit the OnCore Learning Portal at http://docs.onsemble.net

Protocol Creation and Setup | Page 16 of 35

2.

In the popup window, select the checkbox for City of Hope and click Submit.

Add a separate IRB review for an affiliate institution

If an affiliate uses its own IRB (such as Unity Health) a separate IRB Initial Approval must be entered for that affiliate institution. Affiliate institutions using a separate IRB committee must track reviews in their own Institution Console (instead of the PC

Console > Reviews tab).

1.

Navigate to the PC Console > Institution tab.

2.

Click Unity Health to open the Protocol Institution console.

3.

Click the IRB Reviews tab.

4.

Click the Add button.

The process to add an IRB review for an affiliate institution is the same as the process for documenting an IRB review for the Research Center, except that the Submit Date field is a regular date widget (instead of a pre-populated list of past committee meeting dates)

5.

Enter the following review information:

Submit Date: 9/20/2014

Review Reason: Initial Review

Review Type: Full

6.

Enter approval information:

Action: Approved

Approved Date: 10/1/2014

7.

Indicate that the review expires one year after the approval:

Expiration Date: 10/1/2015

Protocol Creation and Setup | Page 17 of 35

8.

Click Submit.

9.

To add a consent document to this review (so that it is available when registering subjects to Unity Health and its study sites), click Add in the Details table.

10.

Enter the following:

Type: Treatment Consent

Received Date: 9/20/14 (same as Submit Date)

Version Date: 10/1/2014 (same as Action Date)

Description: Affiliate Tx Consent V1

11.

Click Save, then click Submit and Close.

12.

Click the PC Console tab to return to the PC Console > Institution tab.

Opening a Protocol for Accrual

Each participating institution on a protocol must be associated with an approved

IRB review before subjects can be enrolled at that institution or any of its study sites. Affiliate institutions can be associated with the Research Center’s IRB review, or a separate IRB review can be documented for an affiliate institution.

After the IRB approves a protocol and all other setup-related tasks and checklists are complete, the study can be opened for subject accrual. Each participating institution must complete their study setup and open for accrual independently; it is very likely that participating institutions will not open on exactly the same date.

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Protocol Creation and Setup | Page 18 of 35

Document additional tasks using checklists

Other tasks that must be performed prior to opening a protocol to accrual are tracked with checklists. Checklists are configurable in Admin > Reference Codes and tasks are completed in the PC Console > Status > Checklists tab.

Protocol checklists are not required and do not impact any other OnCore functionality.

1.

Navigate to the PC Console > Status > Checklists horizontal tab.

2.

Click the Budgets checklist.

3.

Click Update.

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Each checklist item displays as a link. If items are not relevant to the protocol, they can be marked as such by selecting the corresponding Not Applicable checkboxes and clicking the Submit button.

4.

For the first checklist item, enter a target date and comment. For example:

Target Date: m-15

Comment: Budget requested by A. Milne

 Click Submit

5.

Click PC Console to return to the PC Console > Status tab.

A summary of each checklist is provided with status information.

Complete signoffs required by the Research Center

A protocol approved by an IRB can be opened to accrual in OnCore, but other intermediate steps or reviews might be required by your institution. For example, your institution might require signoffs from a CRA, a data monitor or biostatistician, a pharmacist, etc. These signoffs are customizable in each OnCore system and configurable by library.

NOTE: Signoffs are added to OnCore by running a script provided by the Forte engineering team, and then configured (either required or disabled) per library.

Only users with the appropriate privilege can complete the signoff for a protocol.

The instructions below assume that your access role has the privileges required to complete each signoff.

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Protocol Creation and Setup | Page 20 of 35

1.

Navigate to the PC Console > Status tab. If you are in update mode, click

Close to return to read-only mode (the signoff buttons are only visible in readonly mode).

Signoffs must be given sequentially. The names of signoffs and their order will vary depending on your system. In the Forte Training environment, the first signoff is PC Signoff.

2.

Click PC Signoff (or the first signoff available in your system).

3.

Your example protocol was reviewed by the Research Center’s IRB in August

2014 and received all signoffs in September. In the Status Date field, type

9/3/2014, and then click Submit.

The protocol status changes to PROTOCOL COORDINATOR SIGNOFF in the

PC Console header.

4.

If more signoffs are required, repeat steps 2-3 for all additional signoffs and continue until the Open button appears.

Open the protocol at the Research Center

When the Open button appears in the PC Console, the study can be opened for accrual.

1.

In the PC Console > Status tab, click Open.

2.

Your example protocol received all appropriate signoffs in September 2014 and opened in October. Enter a Status Date of 10/1/2014, and then click Submit.

The protocol now has a status of OPEN TO ACCRUAL in the PC Console header.

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Open the protocol at participating affiliates

Opening a protocol at the Research Center does not automatically open the protocol at all participating affiliates; each institution must record its own review dates and status change.

1.

Navigate to the PC Console > Institution tab.

Notice that your protocol has a status of OPEN TO ACCRUAL at the

Outstanding Research Center, but no status listed for the affiliate institutions.

2.

Click City of Hope (or another affiliate institution).

The Protocol Institution console opens for the selected institution.

3.

Click the Status tab, and then click Update.

4.

For Status, select OPEN TO ACCRUAL.

5.

In your example protocol, the affiliate institution opened the study one month after the Research Center. Therefore, enter a Status Date of 11/1/2014.

6.

Click Add.

In the header of the Protocol Institution console, the Institution Status now matches the overall protocol status at the research center:

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Protocol Creation and Setup | Page 22 of 35

7.

Click PC Console to return to the list of participating institutions, and then repeat steps 3-7 to open this study at other participating institutions.

Close, suspend, or terminate a protocol

In the PC Console > Status tab, a protocol can be closed to accrual (temporarily or permanently) by clicking the Close to Accrual, Suspend, or Terminate buttons. The following diagram shows the protocol statuses in OnCore:

Protocol Creation and Setup | Page 23 of 35

Require subjects to reconsent

When there is an amendment that requires subjects to reconsent to the study, record a

Change Review in the PC Console and upload the new version of the consent form.

1.

Navigate to the PC Console > Reviews > IRB horizontal tab.

Verify that the protocol has at least one approved Initial Review with at least one consent form attached.

2.

Click Add to create a new IRB Review.

3.

Enter the following:

Review Reason: Change Review

Action: Approved.

4.

Add other review details as appropriate, and click Submit.

5.

In the Details section, click Add to upload the new consent form.

6.

For Type, select a Treatment Consent.

7.

Enter a Received Date, Version Date, and Description.

8.

Select the Reconsent Required? checkbox, then click Save.

9.

Upload the file from your computer (if desired) and click Submit and Close.

Protocol Creation and Setup | Page 25 of 35

Subjects who consented on the first version of this document will have an RR superscript indicator in the CRA Console. The indicator will also appear on the consent document in the Subject Console until the subject accepts the newer version.

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Protocol Creation and Setup | Page 26 of 35

The RR superscript also appears in the CRA Console.

Other Supporting Documentation for a Protocol

Once a protocol is created, you can attach protocol related documents, record protocol

FAQs, and record document archive information. There are specific tabs to create and manage eligibility questionnaires, enter data in custom protocol annotations, and record and view protocol deviations. You can also associate the protocol with a correlative or companion study.

Attach protocol documents (not consents)

1.

Select the Documents/Info vertical tab.

The Attachments horizontal tab is selected.

2.

Click the Update button, then the Add button that appears at the upper right of the

Protocol Attachments section.

Protocol Creation and Setup | Page 27 of 35

3.

Choose any Document Type.

4.

Click the File link, and then click Choose File to upload a document from your computer.

5.

Enter a Version Date of y-1.

6.

Type a Description of the document

7.

Click Add (to the left of the Cancel button) to save the record.

8.

To add a second document, repeat steps 2-7, choosing a different Document Type.

Staff can now reference the two documents attached to this protocol.

Answer frequently asked questions (FAQs)

The FAQs (frequently asked questions) section is used as a reference to assist staff.

Common questions and answers regarding the protocol, subject eligibility, subject treatment, and so on may be entered here. Staff can view FAQs in the CRA Console.

1.

Navigate to the PC Console > Documents/Info > FAQs horizontal tab.

2.

Click New.

3.

Enter a Question, Answer, and Keywords. For example:

Question: Will subjects be reimbursed for mileage?

Answer: Subjects whose home address is more than 15 miles from their registration site will be reimbursed $0.42/mile for each study visit.

Keywords: Reimbursement, mileage

4.

Click Submit.

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Protocol Creation and Setup | Page 28 of 35

Create an eligibility questionnaire

If an eligibility questionnaire is created for a protocol, research staff can answer the questions directly in OnCore when enrolling a subject in order to determine whether or not the subject is eligible to participate.

An eligibility questionnaire consists of questions that must be answered Yes, No, or Not

Applicable. Choose all answers for each question or criteria that would deem the subject eligible.

1.

Navigate to the

PC Console > Eligibility tab.

There are three tables on the Eligibility tab:

 Eligibility Version History

Lists the questionnaires that have been created for this protocol and the number of subjects that have completed each version.

 Eligibility Summary

Counts subjects whose eligibility has been assessed for this protocol and how many were eligible and not eligible.

 Eligibility Details

Lists all subjects that have completed the questionnaires.

2.

Click Create New Version.

3.

Select the Patient Characteristics category and click Add.

You have the option to select a question used on a previous eligibility questionnaire or to create your own.

4.

Select two questions from other protocols’ eligibility questionnaires, and then click

Submit. For example:

 Is patient at least 18 years of age?

 Is the patient receiving any other investigational agents?

5.

Select the Other category and click Add.

Protocol Creation and Setup | Page 29 of 35

6.

In the Question field, type a new eligibility question, and click Add. For example:

 Does the patient have any prior relationship with <your name>?

NOTE: Eligibility criteria in the form of a question are easier for staff to answer with a Yes, No, or N/A. For example “Does the patient have any concurrent liver-related disease that would preclude participation?” is easier to answer than “No concurrent liver-related diseases that preclude study participation.”

7.

Select the checkbox for your new eligibility question, and then click

Submit.

Several questions have been added to your eligibility questionnaire. Determine the order in which the questions should appear and indicate the answers that will deem the subject eligible for this study:

8.

Enter numbers in the Display Order column to reorder your questions.

9.

Choose the Eligible value for each question (Yes or No). If appropriate, include a possible response of NA.

10.

Click the Submit button.

11.

Click the Release button to make this questionnaire available during subject registration, and then click Close.

Once the eligibility questionnaire is released, a new version can be created for new subjects. This preserves the eligibility history of any subjects who have already been deemed eligible for this study.

If multiple versions of the eligibility questionnaire exist, the most recently released version is used when enrolling new subjects.

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Protocol Creation and Setup | Page 30 of 35

Track additional details in a protocol annotation

Protocol Annotations capture additional protocol details that are not tracked in the standard OnCore fields. Protocol annotations are customized using OnCore’s forms engine. Annotation forms can include number fields, free text, option lists, dates and times. The specific data captured will vary according to each organization’s SOPs.

One protocol annotation form is configured for each OnCore library. Generate a protocol annotation for this study based on this library’s annotation form:

1.

Navigate to the PC Console > Annotations tab.

2.

If no protocol annotation exists for a new study, click Update, then click Create

Annotation Form.

3.

Complete any required annotation fields, and enter data in other fields per your organization’s SOPs. Then click Save.

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Manage protocol deviations

Protocol deviations are added and updated in PC Console > Deviations. Protocol deviations are accidental or unintentional incidents of non-compliance with the study protocol. If necessary, they might be reported to the IRB and/or the protocol sponsor.

1.

Navigate to the PC Console > Deviations > Protocol Deviations horizontal tab.

2.

Click New Protocol Deviation.

3.

Enter the required information for this protocol deviation ( Deviation Date and

Category) and any other appropriate details.

 Example: Enter a Deviation Date of w-1.

 Example: Choose a Category of Other.

 Example: Enter a Description of Deviation of “PI’s laptop was stolen; subject accrual temporarily suspended.”

 Example: Enter an Action Taken of “IT department alerted; procedures were followed to change all necessary passwords and alert the authorities.”

4.

Indicate that this deviation was reported to the IRB immediately, and it was also reported to the sponsor.

 Report to IRB?: Immediately

 Report to Sponsor?: Yes

 Date Reported to IRB: t

 Date Reported to Sponsor: t

5.

Click Submit and then Close.

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Protocol Creation and Setup | Page 32 of 35

Protocol Creation and Setup | Page 33 of 35

Review subject deviations

Subject deviations are recorded by the study team in the CRA Console or Subject

Console. They can be viewed and updated in the PC Console > Deviations tab and marked as Reported to IRB.

A new protocol without any accruals will have no subject deviations reported yet. To see an example of a protocol with reported subject deviations, open protocol CARD0815 or

ONCWV0116 and navigate to the Deviations > Subject Deviations horizontal tab, as shown in the following screenshot:

You can use the Show Only Unreported Deviations checkbox in the upper-right to filter your view. This page also allows you to add an IRB Reported Date to one or more deviations by selecting the checkboxes for those deviations, entering a date in the

Update Selected IRB Reported Dates field, and clicking Update.

NOTE: Do not make changes to these example protocols. Be sure to open your own protocol before proceeding to the next section.

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Protocol Creation and Setup | Page 34 of 35

Adding a correlative or companion study

If a protocol has one or more associated companion studies, research staff can see those suggested companion studies when registering subjects in the Subject Console and quickly enroll subjects on the companion studies, if appropriate.

The Correlates & Companions tab in the PC Console appears if the Involves Correlates or Companions field on the Main > Details page is set to Yes.

When the Correlates & Companions tab is available, a study can be associated with

(“linked to”) any protocols flagged as companion studies (the Companion Study? checkbox on the PC Console > Main > Details page is selected).

Protocol Creation and Setup | Page 35 of 35

Protocol Calendars in OnCore

In OnCore, the calendar describes when a subject will be seen (visits), what will be done during each visit (procedures), and what visit data will be recorded (eCRFs, or forms). Calendars in OnCore progress through three stages:

Specification

Think of this as a calendar-in-progress.

Specifications define the schedule of visits, procedures, and forms in a protocol calendar.

Location: View and edit specifications in the eCRFS/Calendars > Specifications menu.

Protocol Calendar

The protocol calendar is the finalized schedule of visits, procedures, and forms that is used as a blueprint for the subject calendar.

Location: View only: PC Console or CRA

Console. Edits must be made in the specification.

Subject Calendar

A personalized subject calendar is automatically generated based on the visit schedule defined in the protocol calendar. The subject calendar shows planned visit dates and occurred visit details.

Location: View and edit in the Subject Console.

This chapter covers Specifications and Protocol Calendars. Subject Calendars are covered in a later chapter.

Protocol Calendars | Page 1 of 33

Creating a Protocol Specification

To create a protocol calendar, you must begin with a protocol specification. When you navigate to the eCRFS/Calendars > Specifications menu in OnCore, you see two types of specifications: specification templates and protocol specifications.

Specification templates define a set of visits or procedures common to many protocols and are used as the starting point for a protocol specification. A protocol specification is associated with a specific protocol and is where you define all visits, procedures, and forms included in the protocol calendar.

Create a new specification template

1.

Navigate to eCRFs/Calendars > Specifications.

The first time you navigate to this menu item, OnCore opens the Specification

Templates tab.

NOTE: If you navigate to this menu item after selecting a protocol elsewhere in

OnCore, you will be directed to the specification associated with your protocol instead.

Specification templates are listed in a table with the columns Specification No.,

Library, Title, Description, and Status . A template status can be New,

Complete, or Released (not editable). Templates of any status can be used as the basis for other templates or protocol specifications.

2.

Click the New Template tab, and then enter the following data:

Spec No.: SPEC-your initials

Spec. Title: Your Name Spec Title

Spec. Description: Your Name Spec Description

Each Specification Template is associated with a single Library. The Library selection limits the protocols to which the template may be applied.

Library: Select Cardiology or Oncology, depending on the Library you selected for the protocol you created in the PC Console training session.

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Protocol Calendars | Page 2 of 33

3.

Click Create.

The specification template you created is now listed in the table with a status of New. Currently, your specification template is blank. At this point, you could add visit schedules to the template. Instead, the next instruction will show you how to use your blank template as the starting point for a protocol specification.

Create a protocol specification

The following steps allow you to create a new protocol specification from the blank template you just created.

1.

On the Specification Templates tab, locate the template you just created.

Click the SPEC-your initials link. Note that your Specification No. appears in the upper left of the page header.

2.

To attach your template to a protocol, click the Save As tab.

The top section of the page allows you to save your specification template as a new template (creating a copy of your template). The bottom half of the page allows you to create a protocol-specific specification based on your template.

NOTE: Each section of the page has its own Save button, which saves changes only in the corresponding section.

3.

In the Attach Specification to Protocol section, use the Protocol field to select your protocol (PROT-your initials), and then click the corresponding

Save button.

NOTE: The Protocol find-as-you-type field searches only those protocols in the same library as the selected specification.

4.

Click the Specifications tab.

You are returned to the Specifications menu with the Protocol Specifications tab highlighted. The table lists all protocol specifications in OnCore, identified

Protocol Calendars | Page 3 of 33

by their Protocol No. For protocol specifications with multiple versions, the

Protocol Title column lists all version numbers as links.

5.

Locate your new protocol specification in the list. Note that it is shown as

Version 1, with a Status of New. It may now be edited.

Components of a Calendar

As you know, the calendar is composed of visits and events. To understand how these are added to a calendar, the first step is to understand treatment segments.

Treatment segments are “chunks” of time that begin on a subject milestone date.

Visits are scheduled within treatment segments. A protocol specification consists of one or more treatment segments, and each treatment segment must have a trigger or milestone date that indicates the beginning of the treatment segment.

Subject milestones are selected as the Start Date for a treatment segment. The segment can be based on any of the following milestones:

 Consent Signed

 On Study

 On Arm

 On Treatment

 Off Treatment

 Off Arm

 Off Study

 On Follow Up

 End Of Previous (simply allows one segment to follow another segment)

A treatment segment may be a simple duration of time (e.g., 30 days), or it may be durations of time that repeat (four sets of 28 days). Repeating “chunks” of time are called cycles (e.g. four cycles of 28 days).

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Protocol Calendars | Page 4 of 33

Within a treatment segment, subject visit dates are defined. Examples of visit date definitions are

 “the first and fifth day of the segment”

 “the first, tenth, and eighteenth day of each cycle”

Because treatment segments are based on subject milestones, subject visit dates are also based upon subject milestones.

There are two vertical tabs used to create the final calendar.

Treatment Visits tab

This tab allows you to define segments. There are two horizontal tabs within the Treatment Visits vertical tab. o

(Pre-Treatment) Treatment tab

This tab is (generally) used to define treatment segments encompassing the time from Consent Signed to End of Treatment. o

Follow Up tab

This tab is (generally) used to define treatment segments that begin after subject treatment.

Calendar tab

Allows you to define the events (labs, panels, and procedures) that will be performed, the visits the events correspond to, and the forms that will capture the data for these events

When you define treatment segments on the Treatment Visits tab, you will use the following attributes:

Segment Attribute Purpose

Seq. No

Name

Start Date

Each segment must be given a number. A calendar can consist of multiple segments, and the sequence numbers assist in determining their order.

Giving a segment a name makes a calendar easier to understand.

The subject milestone date when this segment begins.

Protocol Calendars | Page 5 of 33

Segment Attribute Purpose

Time Unit Is the segment defined as a number of Days, Weeks,

Months, or Years?

No. Of Repetition(s) When a segment defines cycles, this is the number of cycles. If the segment is a duration of time (not cycles), this field is left blank.

Visit(s) When a segment defines a duration of time (not cycles), these are the days when subject visits are scheduled.

(Specifying visit days for cycles is done on another screen.) NOTE: You will either enter data for No. Of

Repetition(s) or Visit(s)—not both.

Duration When a segment defines a duration of time, this indicates the total segment duration. When a segment defines cycles this indicates the duration of each cycle.

The duration of visit-based segments must be greater than or equal to the last visit in the segment.

Exclude Weekend When visits defined for this segment fall on a weekend, selecting this checkbox will move the visit to the following

Monday. Subsequent visits are also shifted by the same number of days.

What is the Description/Notes tab used for?

The Description/Notes tab allows you to add a brief description (20 characters) as well as additional explanatory notes (4000 characters) about the version of the calendar. The Description appears in the CRA and Subject Consoles when selecting the calendar version to which to upgrade the subject. The Description also appears in PC Console > Institution when Institution-Specific Calendar Version functionality is in use.

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Protocol Calendars | Page 6 of 33

Creating Treatment Segments

Protocol specifications are designed using subject milestone dates, rather than actual dates. Visits are based upon offsets from these milestones, such as “the day the subject starts on the study" or "the first and fifth days of treatment.”

The Protocol Calendar is a blueprint for the subject calendar. As each subject’s milestone dates are recorded in the Subject Console, the subject calendar is automatically generated using actual dates.

Create a treatment segment with a single visit

The sample calendar on page 7 shows a Baseline segment, consisting of a single visit called Screening. The calendar indicates that the visit must be within 14 days of the date the subject signs the informed consent form. The following instructions show how to create the Baseline segment.

1.

From

eCRFs/Calendars > Specifications > Protocol Specifications tab, click the link for your protocol specification (

PROT-your initials).

The Study Specification opens on the Treatment Visits tab. If any treatment segments were defined for your specification, they would be listed in the

Treatment table.

2.

Click Update.

The Treatment Visits tab now shows two horizontal tabs, with the

(Pre-Treatment) Treatment tab selected. The Add Segment section allows you to add new treatment segments, which will appear in the Treatment table below as they are created.

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Protocol Calendars | Page 8 of 33

3.

4.

In the first row, enter the following values:

Start Date: Consent Signed

Time Unit: Day

Before you enter data into the second row, you must identify whether the

Good to know

Sequence No: 10

Name: Baseline

It’s a good idea to leave gaps between your sequence numbers (e.g., 10, 20, 30, 40) in case you need to insert additional segments in subsequent calendar versions.

Sequence numbers are only visible to the calendar builder. segment is a cycling segment (consisting of a schedule of visits that repeat at least once), or a one-time segment (consisting of one or more visit dates that do not repeat). Since the Baseline segment in the sample calendar (page 7) consists of a single non-repeating visit, it can be scheduled as a one-time segment.

Therefore, you will enter data into the Visit(s) and Duration fields (leaving the

No. Of Repetitions field blank).

Visit(s): 1 (the visit occurs on the first day of the segment)

Duration: 1 (the segment consists of a 1-day-long period of time)

Exclude Weekend: leave unselected

5.

At the bottom right of the Add Segment section, click Add.

The newly created segment is displayed in the Treatment table.

NOTE: The Arms column does not show a value for the segment you created.

Segments with a Start Date of Consent Signed, On Study, Off Treatment, and

Off Study always apply to all subjects on all arms. Other segments (starting with On Arm, On Treatment, End of Previous, and Off Arm) may be defined as arm-specific, depending on the requirements of your protocol.

Protocol Calendars | Page 9 of 33

Create a cycle-based treatment segment

In the sample calendar, the Treatment segment consists of 6 cycles of 28 days, with visits on Days 1 and 15 of each cycle. To begin, you will create a cycling segment by defining a Number of Repetitions (6) and a Duration (28 days).

1.

In the Add Segment section, enter the following values:

Sequence No: 20

Name: Treatment

Start Date: On Treatment

Time Unit: Day

No. Of Repetition(s): 6

Duration: 28

Exclude Weekend: leave unselected

Open Ended: leave unselected

2.

At the bottom right of the Add Segment section, click Add.

In the Arm column of the Treatment table, you can see that this segment has been applied to both Arm A and Arm B. When the segment is created, all arms are automatically selected.

Good to know

If a specification is created before treatment arms have been defined in the PC

Console, the Arms column will show a blue dash. After arms are defined, click the dash to select the appropriate arm(s).

Where do I define the visits in a cycling segment?

You have defined this Treatment segment as a 28-day period of time that repeats six times. Note that there was no place to indicate that visits occur on Days 1 and

15 of the cycle. Cycle-based segments differ from one-time segments in that you do not define cycle visits on the Treatment Visits tab. Instead, you will define the Day 1 and Day 15 visits later, when you schedule the calendar procedures.

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Protocol Calendars | Page 10 of 33

Create a segment with a Start Date of End of Previous

On the sample calendar, the Maintenance segment is also cycle-based, but it is triggered by the end of something (Treatment) rather than the start of something.

This scenario is handled by using the Start Date called End of Previous. End of

Previous is the only Start Date option that is triggered by another part of the calendar, rather than a subject milestone date.

1.

In the Add Segment section, enter the following values:

Sequence No: 30

Name: Maintenance

Start Date: End Of Previous

Time Unit: Day

No. Of Repetition(s): 3

Duration: 14

Exclude Weekend: leave unselected

Starting Number: leave blank

2.

At the bottom right of the Add Segment section, click Add.

3.

The sample calendar indicates that the Maintenance segment applies only to

Arm A. Since all arms are selected by default, we’ll need to disassociate Arm B from this segment. In the Treatment table, in the row for Seq. No. 30, click the

ArmA, ArmB link.

4.

Unselect the checkbox associated with ArmB, and then click Submit.

The link in the Arms column now shows ArmA.

You have defined the Maintenance segment so that it begins on the day following the final day of the Treatment segment. In this case, that would be after 6 repetitions of 28, or 168 days after the subject’s On Treatment date.

Protocol Calendars | Page 11 of 33

Create a segment with multiple visits

The sample calendar indicates that after subjects are off treatment, they need to come in for a Week 1 and a Week 2 visit. Because the visits schedule is calculated in weeks, the Time Unit field will be set to Weeks in this segment.

1.

In the Add Segment section, enter:

Sequence No.: 40

Name: Off Treatment

Start Date: Off Treatment

Time Unit: Week

Visit(s): 1,2 (defines visits on week 1

and week 2 of the segment)

Duration: 2 (indicating that the

segment spans a period of 2 weeks)

Exclude Weekend: leave unselected

Good to know

Segments with a Time Unit of

Week allow you to schedule a single visit on the first day of the week. If you need multiple visits within a week, you must use a

Time Unit of Day.

2.

At the bottom right of the Add Segment section, click the Add button.

After adding the Off Treatment segment, you will see the following schedule in the

Treatment table:

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Protocol Calendars | Page 12 of 33

NOTE: You can see that, although you defined the Visits for the Off Treatment segment as “1,2”, OnCore saved them as a range using a colon (1:2). OnCore gives you the flexibility to list sequential visits either as a comma-separated list (1,2,3,4,5) or as a range (1:5). If you enter a comma-separated list of sequential visits, it will be displayed as a range when the list is saved.

Create follow-up segments

The sample calendar shows two types of follow-up visits: in-clinic every six months for the first two years, and then by phone annually after that. This is represented in

OnCore by two follow-up segments.

Follow-up segments are created on the Treatment Visits > Follow-Up tab. Follow-up segments can be an offset of the subject’s On Study or On Follow Up date. The following instructions detail how to set up two follow-up segments with a Start Date of On Follow Up.

Adding a follow-up segment is similar to adding a treatment segment, except when defining cycles. Whereas treatment segments use a single Duration field to define the length of time between Start Date and the end of the segment, follow-up segments use three fields to define cycles: Duration Begin, Duration End, and

Interval. The following instructions demonstrate how these fields work together to create the follow-up segments on the sample calendar.

1.

Click the

Follow-Up horizontal tab. In the Add Segment section, enter:

Seq. No: 50

Name: In-clinic Follow Up

Start Date: On Follow Up

Time Unit: Month

Duration Begin: 6 (begins 6 months after the On Follow Up date)

Duration End: 24 (ends 24 months after the On Follow Up date)

Interval: 6 (visits occur every 6 months within the segment)

Protocol Calendars | Page 13 of 33

2.

At the bottom right of the Add Segment section, click Add.

The In-clinic Follow Up segment appears in the Follow-Up table.

3.

The sample calendar also includes a second Follow-Up Segment, in which visits begin three years after starting follow-up, and occur annually through

Year 6.

4.

In the Add Segment section, enter:

Seq. No: 60

Name: Annual Follow Up

Start Date: On Follow Up

Time Unit: Year

Visit(s): 3:6 (indicating that visits occur on years 3,4,5 and 6)

IMPORTANT

Segments within the calendar should not overlap, meaning the same visit should not exist in multiple segments. Since the In-clinic follow up segment goes through Year 2, our Annual Follow Up will begin at Year 3.

Duration: 6

NOTE: OnCore calendars support multiple ways to achieve the same goal.

You could also set up the Annual Follow Up segment as Duration Begin = 3 and Duration End = 6 with an Interval of 1. In both cases, the Duration/Duration

End must be at least 6 Years since that is the last visit in the segment.

5.

At the bottom right of the Add Segment section, click Add.

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Protocol Calendars | Page 14 of 33

6.

Click Close. You should see the following:

IMPORTANT

By default, follow up segments apply to all subjects and ignore subject treatment arm assignments. If a follow up segment should apply only to subjects who were assigned a particular arm during the study, click the word None in the Arms column and select the appropriate arm(s).

You now have six segments defining blocks of time where subject visits can occur. In the Screening segment, you have already indicated that a visit occurs on the first day of the segment. In the Off Treatment segment, visits occur on the first day of weeks 1 and 2 of the segment. For the other, cycle-based, segments the visit days have yet to be determined.

The next step is to define the labs, panels, and procedures that will be conducted on this protocol. These are defined via the Study Specification >

Calendar vertical tab.

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Add Procedures to the Calendar

You have defined the timeline for your protocol specification. Now you will add the events (labs, panels, and procedures) that will be performed during subject visits. If you have left your protocol specification, navigate to eCRFs/Calendars >

Specifications > Protocol Specifications, and select PROT-your initials.

1.

Click the Calendar tab.

Even though you’ve defined the segments for the calendar, they don’t appear on the Calendar tab yet. To see the calendar start to take shape, you need to add the procedures listed on the sample calendar.

2.

On the lower right of the page, click Add Procedures/Labs.

A pop-up window opens, displaying a find-as-you-type Clinical Procedure field.

The field locates events that have been defined in the Admin > Labs and

Panels page, as well as procedures that have been added to other specifications. You have the option of selecting an existing procedure or adding a new procedure. For this sample calendar, all procedures already exist in the

OnCore Training environment.

3.

In the

Clinical Procedure field, start typing the name of the procedure to see a list of potential matches. When each is displayed in the field, click

Add.

Adverse Events

Physical Exam

Blood Chemistries (look for the match with a Type of Lab)

Complete Metabolic Panel (look for the match with a Type of Panel)

Treatment Administration

Imaging

Tumor Biopsy

Quality of Life

4.

After you have added each procedure, click Submit.

The selected procedures appear as links in the Procedure column.

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Protocol Calendars | Page 16 of 33

Scheduling Procedures and Attaching Forms

Now that you’ve identified which procedures will be done throughout the course of the study, you can associate them with specific visits and forms (eCRFs).

Schedule procedures on specific visits

The following instructions explain how to schedule the Quality of Life procedure from the sample calendar. This procedure is scheduled on both the Screening and

Annual Follow Up visits.

1.

In the Procedure column, click Quality of Life.

The Procedure Details: Quality of Life page opens, where you can schedule the procedure and attach a form.

2.

On the right side of the Schedules section, click Visits/Schedules.

A pop-up window opens with two horizontal tabs:

 Visits

Allows you to schedule the procedure on enumerated visits (visits you defined on the Treatment Visits tab as part of a non-cycling segment) and on visits associated with Follow-Up segments

 Treatment Schedules

Used to schedule the procedure on a specified schedule within a cyclebased segment

3.

Since the Quality of Life procedure occurs in non-cycling segments, remain on the Visits tab. Within the Baseline segment, select the D1 checkbox. Select the

Annual Follow Up checkbox, which automatically selects all of the visits

(Years 3, 4, 5, and 6) within the segment.

4.

Click Submit, and then click Close to return to the Procedure Details page.

The visits you selected are listed in the Schedules section. Note that the

Treatment and Follow Up schedules are separated by a horizontal rule.

Protocol Calendars | Page 17 of 33

5.

On the sample calendar, there is a form associated with the Quality of Life procedure. To add the form, click the Select Forms button in the Forms section of the page.

A pop-up window opens with a list of forms assigned to your protocol’s library.

6.

Type QL in the Filter field and press Enter to filter the list.

Good to know

When you select forms, OnCore can identify whether you are attaching the form to a procedure or a lab. Therefore, forms that contain a

Usage-Specific Lab section only display in the list of forms when you have selected a lab.

7.

Select the checkbox for the QL-001 V1 form and click Submit to attach the form to the procedure.

8.

On the Procedure Details page, click Close. You should see the following:

The calendar grid includes columns for the Baseline and Annual Follow Up visits. The schedule you defined is shown, along with the selected form.

9.

Follow a similar process to schedule the Physical Exam procedure. Click the

Physical Exam link.

The Procedure Details: Physical Exam page opens, where you can schedule the procedure and attach a form.

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Protocol Calendars | Page 18 of 33

10.

Click Visits / Schedules. Remain on the Visits tab, and select the following:

 In the

Baseline segment, select D1.

 In the Off Treatment segment, select W2.

11.

Click Submit, and then click Close to return to the Procedure Details page.

12.

The sample calendar indicates that the PE-001 V1 form is associated with the

Physical Exam procedure. In the

Forms table at the bottom of the display, click

Select Forms.

13.

Type PE in the Filter field and press Enter to filter the list.

14.

Select the checkbox for the PE-001 V1 form and click Submit to attach the form. Click Close to return to the Calendar tab.

Schedule procedures on cycle-based visits

According to the sample calendar, Adverse Events should be assessed at the

Screening visit, on Day 1 of each treatment cycle, and at each of the Follow Up visits. You will use the method you just learned to schedule the procedure for

Screening and Follow Up, and learn a new method for scheduling on Day 1 of each cycle.

1.

In the Procedure column, click Adverse Events.

The Procedure Details: Adverse Events page appears where we can schedule the procedure and attach a form.

2.

Click Visits/Schedules. Remain on the Visits tab, and select the following:

 In the Baseline segment, select D1.

 Select In-clinic Follow Up and Annual Follow Up to select all Follow

Up visits.

NOTE: Since you built the In-clinic Follow Up segment using Duration Begin,

Duration End, and Interval, procedures are scheduled to all visits within the

Protocol Calendars | Page 19 of 33

segment. Alternatively, procedures can be scheduled on the Year 3, 4, 5, and 6 visits independently since you used enumerated visits for that segment.

3.

Click Submit to save your work, and then click Treatment Schedules to schedule the procedure on the cycle-based visits.

The Treatment Schedules tab allows you to schedule procedures for cyclebased treatment segments. The Cycles drop-down allows you to select the cycles within the segment to which the procedures applies.

Cycles

All

Even

Indicates that the procedure applies to:

All cycles

Every even-numbered cycle

Odd

From

Every odd-numbered cycle

Every cycle from a specified number onward; a field appears to specify the number (e.g., when the segment includes 5 cycles, selecting “From 3” indicates that the procedure applies to Cycles 3, 4, and 5)

Cycles Only specified cycles; a field appears to specify the number(s). (e.g., “Cycles 2,3” indicates that the procedure applies to Cycles 2 and 3).

Every Every x number of cycles; two fields appear to indicate the starting cycle and interval (e.g., “Every 2 cycles from

Cycle 3” indicates that the procedure applies to cycles

3,5,7,etc.)

The other fields in the Treatment Schedules tab change depending on the value selected for the Cycles field.

4.

Since the Adverse Events assessment needs to happen on Day 1 of all six cycles, select the following:

Cycles: All

Days: 1 (indicates that the procedure occurs on Day 1 of each cycle)

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Protocol Calendars | Page 20 of 33

5.

Click Add.

The schedule you created appears in the table. You can apply this schedule to the selected procedure; it will also be available for selection when you schedule other procedures.

6.

Select the checkbox associated with the schedule you created, and then click

Submit. Click Close to return to the Procedure Details page.

7.

The study flowchart indicates that the AE-001 V1 form should be filled out when the Adverse Events assessment is performed. In the Forms table, click

Select Forms.

8.

Type AE in the Filter field and press Enter to filter the list.

9.

Select the checkbox for the AE-001 V1 form and click Submit to attach the form.

10.

Click Close to return to the Calendar tab. Your newly scheduled procedures appear on the grid as follows:

11.

Next, use the same process to schedule the Treatment Administration procedure on Day 1 of each treatment cycle. Click the

Treatment

Administration link.

12.

Click Visits/Schedules and then the Treatment Schedules horizontal tab.

13.

The treatment schedule that you defined for the Adverse Events procedure is already listed in the Schedules table. Since the Treatment Administration uses

Protocol Calendars | Page 21 of 33

the same schedule, simply select the checkbox for the All Cycles Visit 1 schedule, click Submit and then Close.

14.

On the Procedure Details page, click Close to return to the Calendar tab.

The Treatment Administration procedure is now scheduled for the same visits as the Adverse Events procedure.

15.

The Imaging and Tumor Biopsy procedures also happen during each treatment cycle, but they occur on Day 15. Therefore, you will need to create an additional schedule for the Day 15 visits. Click Imaging.

16.

Click Visits/Schedules and then the Treatment Schedules horizontal tab.

17.

Since the Imaging assessment needs to happen on Day 15 of all six cycles, enter the following:

Cycles: All

Days: 15 (indicates that the procedure occurs on Day 15 of each cycle)

18.

Click Add. Select the checkbox that corresponds with the All Cycles Day 15 schedule, click Submit and then Close.

19.

Click Close to return to the Calendar tab, and then repeat the process for the

Tumor Biopsy procedure. Be sure to reuse the schedule you just created for

Imaging.

20.

Attach a form of your choice, and then return to the Calendar tab.

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Protocol Calendars | Page 22 of 33

Schedule a lab

The last two items on the sample calendar (page 7) are Blood Chemistries and

Complete Metabolic Panel. The Procedure Type for each of these items is Lab and

Panel, respectively, which means that additional information is pulled from Admin >

Labs and Panels. There are specific lab tests associated with each. This set of instructions demonstrates how labs and panels are different from other procedures.

1.

In the Calendar tab, click Blood Chemistries to open the Lab Details page.

2.

Because this is a Lab, an Items section appears at the top of the page. In the

Items section, click the Select Items button.

3.

The pop-up window shows the list of items associated with the Blood

Chemistries lab, allowing you to choose which items are applicable to the protocol. Select the checkboxes for

Amylase, LDH, Sodium, and Uric Acid.

Then, click Submit to return to the Lab Details page.

4.

Click Visits/Schedules. On the Visits tab, select the following and then click

Submit:

 In the Off Treatment segment, select W1

 Select In-clinic Follow Up to include all visits in the segment

5.

Click the Treatment Schedules tab to schedule the procedure on Days 1 and

15 of each treatment cycle.

Since you’ve already created schedules for Day 1 and Day 15 for other procedures, you can re-use the existing schedules rather than creating a new one that includes both visits.

6.

Select the checkboxes for the All Cycles Day 1 and All Cycles Day 15 schedules and then click Submit.

Protocol Calendars | Page 23 of 33

7.

Because the Blood Chemistries lab is also used in the Maintenance segment, you need to create another schedule that accounts for those visits. In the

Add

Schedule section, select the following, and then click Add.

Segment: Maintenance

Cycles: All

Days: 1

8.

The schedule you just created appears in the table, but it is not yet selected for the lab. Select the checkbox that corresponds with the Maintenance segment, click Submit, and then click Close.

You return to the Lab Details page, and the Schedules section now shows the visits on which the Blood Chemistries lab will occur.

9.

The sample calendar indicates that the FB-BC: THX-CTMS-REV.03A V1 form should be filled out when the Blood Chemistries lab is performed. Click the

Select Forms button and attach the form, and then click Close to return to the

Calendar tab.

10.

Click Close to return to the Calendar tab.

The Blood Chemistries lab is now scheduled on the calendar grid. The selected lab items are listed below the lab in the Procedure column.

You’ll notice that the Treatment portion of the calendar is now divided into two distinct sections: one for Arm A and one for Arm B.

Arms with different schedules are color-coded to help you distinguish between them. If the schedule is identical for all treatment arms,

OnCore saves space on the page by consolidating the calendar.

Good to know

OnCore offers two features to make calendars easier to view:

 The Freeze Panes button anchors the Procedure column, allowing you to scroll to the right while maintaining the procedure list as a reference.

 At the top right corner of the

Calendar tab, the Arm drop-down gives you the option to view each arm of the calendar separately.

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Protocol Calendars | Page 24 of 33

Indicate that a procedure/lab occurs twice in a visit

On the sample calendar (page 7), the Blood Chemistries procedure is indicated with a 2X, meaning that it should be performed twice during each visit.

1.

On the Lab Details: Blood Chemistries page, click Details.

2.

In the pop-up window, all visit schedules are listed. In the

No. of Occurrences

column, enter 2 for every visit, and then click Submit.

3.

On the Lab Details page, click Close to return to the Calendar tab.

You can see that the calendar grid now indicates that the Blood Chemistries procedure occurs twice on each visit for which it is scheduled.

NOTE: Even though the Blood Chemistries procedure is scheduled twice on each visit, only one copy of the associated form is generated for each subject visit. You will learn how to add additional forms in this scenario when in the

Subject Calendars training session.

Schedule a panel

The process to schedule a panel is the same as scheduling a lab. Like labs, panels consist of component items. However, when initially editing the panel, all panel items are included. Even though all panel items are evaluated by the lab, you may only want to track the relevant items on your forms in OnCore. In that case, OnCore allows you to remove those items from the calendar.

1.

Follow the steps used to schedule the Blood Chemistries lab to schedule the

Complete Metabolic Panel. (In the sample calendar, the schedules are identical.)

2.

Attach the LE-CBC001 V1 form, as indicated in the sample calendar.

Protocol Calendars | Page 25 of 33

3.

Click Close on the Lab Details page to return to the Calendar tab and confirm that your panel has been scheduled correctly.

Customize Procedure Order, Visit Names, and Visit

Tolerances

There are several features within OnCore calendars that make them easier for end users to understand.

Reorder procedures

By default, the procedures on the calendar are organized in alphabetical order. You may want to make the order match the study flowchart in the protocol.

1.

Click the blank space to the right of the Physical Exam hyperlink.

The row’s background color will change to blue, and a set of buttons appears below the calendar.

2.

Use the Up button to move Physical Exam beneath Adverse Events.

3.

Use the same method to update the rest of the procedures so the order matches the sample calendar (page 8).

4.

Click Save Order to preserve the changes.

NOTE: If you navigate away from this page without clicking the Save Order button, your re-ordering will be lost and you will have to do it again.

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Protocol Calendars | Page 26 of 33

Update visit names and set visit tolerances

The names that OnCore assigns to visits may not be what you want to appear on the calendar. For example, the visits in the Baseline and Off Treatment segments are both named D1. OnCore allows you to change these visit names. You can also indicate the allowable date range for each visit. The following instructions show you how to rename these visits and to set visit tolerances.

1.

On the Protocol Specification > Calendar tab, click the Baseline segment.

A popup window opens, with each visit in the treatment segment listed.

2.

Enter the following:

New Visit Description: Screening

Visit - Tolerances: 0

Visit + Tolerances: 14

3.

Click Submit.

Notice that the D1 visit description on the calendar has changed to Screening.

This description will also be used on subject calendars. The visit tolerance information can be seen from subject calendars.

4.

Click Treatment segment.

Since all of the visits can happen within +/- 1 day of their Planned Date, you can use the segment-level tolerances at the top of the popup.

5.

Enter the following:

- Tolerances: 1

+ Tolerances: 1

6.

Click Submit.

You can see that your visits have been renamed. The visit tolerances you set will be enforced when clinical staff users check in subject visits; any visits that are given an Occurred date outside of the tolerance will automatically generate

Protocol Calendars | Page 27 of 33

a visit outside tolerance record, which can prompt users to create a subject deviation if necessary.

Adding Footnotes

Footnotes can be added to three areas on a calendar:

 Procedures

 Visits

 Visit procedures (that is, on a procedure during a specific visit)

Footnotes allow you to provide additional information or instructions to the study team, located on the visit or procedure to which the information applies.

Add a footnote to a procedure

1.

On the Protocol Specification > Calendar tab, click the Imaging procedure.

2.

In the Foot Notes section, click Select Footnotes.

3.

In the Index field, enter A.

4.

In the Foot Note field, type: Conducted via MRI, CT Scan, or Ultrasound.

5.

Click Add.

6.

Select the corresponding Select? Checkbox and click Submit.

The footnote appears in the Foot Notes table on the Procedure Details page.

7.

Click Close.

The footnote appears at the bottom of the Specifications page, and its index appears next to the procedure.

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Protocol Calendars | Page 28 of 33

Add a footnote to a visit

1.

On the Protocol Specification > Calendar tab, click Add at the upper right of the Calendar Foot Notes section at the bottom of the page.

All visits are shown in a table, allowing you to select the visit(s) to which the footnote(s) should apply.

2.

In the Index field, enter B.

3.

In the Foot Note field, type: Must occur within 28 days after Screening.

4.

Select the checkboxes for the C1D1 visits in the Treatment segment for ArmA and ArmB.

5.

Click Submit.

The footnote appears at the bottom of the Specifications page, and its index appears next to both C1D1 visit names in the Treatment segments.

Add a footnote to a visit procedure

1.

To add a footnote to a particular procedure on a particular visit, create the footnote using Steps 1, 2, 3, and 5 in the section above. (Supply your own

Index and Foot Note.)

Your footnote should appear at the bottom of the Specifications page.

2.

Click the

Tumor Biopsy procedure.

On the procedure’s Procedure Details page, the footnote may be selected using the Select Footnotes button. After the footnote has been selected for the procedure, it will appear in the Foot Notes table with a Visits link at the far right.

3.

Click Visits.

4.

Select checkboxes for the visits of your choice and click Submit.

Protocol Calendars | Page 29 of 33

5.

Click Close.

The footnote appears at the bottom of the Specifications page, and its index appears next to the selected visit for the selected procedure.

Flag a procedure as “As Needed”

Procedures can be flagged as “As Needed,” indicating that the procedure should be scheduled on the calendar, but the coordinator has some discretion as to whether the procedure is done. This is the case for all procedures, but an As

Needed procedure is given an AN superscript marker (and automatic footnote) on the calendar to draw attention to it. An example of an As Needed procedure might be a pregnancy test or some other procedure that is optional depending upon the results of an earlier procedure.

Want to learn more?

For more information on using

As Needed procedures in your calendar, see the Study

Specification/Calendar page of the Learning Portal.

Releasing a Protocol Calendar

To use the schedule of visits that you have created, you must release the protocol specification to make it available as a finalized protocol calendar. Remember that protocol specifications are considered calendars-in-progress; it is the finalized protocol calendar that generates the customized subject calendars. Before you release the protocol specification, it’s a good idea to do a final check of the visits, procedures, and schedules.

Preview the calendar

OnCore’s calendar preview feature allows you to double-check the visit structure using example subject milestone dates.

1.

Click the Preview Calendar button in the upper right corner of the Calendar tab.

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Protocol Calendars | Page 30 of 33

2.

Select Arm A.

3.

Enter the following milestone dates:

Consent Signed Date: y - 1

On Treatment Date: m - 11

Off Treatment Date: m - 4

On Follow Up Date: m - 3

4.

Click Preview.

Planned Dates are generated for each of the Arm A visits.

5.

Click the red

X to remove the example milestone dates.

Manage the calendar status

The calendar is currently in the New status, as indicated in the top right corner of the header. As long as the calendar is New, it can be modified in eCRFs/Calendars

> Specifications and is not available for subjects. To indicate that it is ready for use, you must complete and release it:

1.

Navigate to your protocol specification page ( eCRFs/Calendars >

Specifications tab > select your specification).

2.

Click the Complete button.

A specification with a status of Complete should not be edited. It is a way to indicate that the calendar is ready to be checked by someone else.

NOTE: Depending upon your system configuration, Signoff buttons may appear. These must be applied by users with the appropriate privileges until the Release button appears.

Protocol Calendars | Page 31 of 33

3.

Click any Signoff buttons that appear, and then click the Release button.

After a specification is released, it can be used by a protocol. Once released, it will be used to generate subject calendars based on each subject’s milestone dates.

You've successfully created a protocol calendar. When subjects are accrued to a protocol that uses this protocol specification, a calendar will be created for them based upon your work.

Change a form version

After the specification has been released, there may be a time when the PI wants slightly different information on the forms. OnCore gives you the ability to switch the version of a form without having to make a new version of the calendar. Once you’ve created the new version of the form, you will follow these steps.

1.

Navigate to your protocol specification page ( eCRFs/Calendars >

Specifications tab > choose your specification).

2.

Click the Calendar tab if you aren’t already on it.

3.

Click the FB-BC: THX-CTMS-REV.03AV1 link (the Blood Chemistries form).

4.

The Form Customization tab appears. Use the Upgrade to Version 2 button to switch to the new form version.

5.

Confirm your decision and click the Upgrade button.

Every subject form of this type for the procedure for this version of the calendar will be changed to the new version. Any data that was previously entered will be retained, even for fields that have been retired. Any new fields that have been added to the form will, by definition, not have data in them.

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Protocol Calendars | Page 32 of 33

Note: OnCore connects each subject visit with the version of the calendar the subject was on at the time the visit was checked in. When there are multiple versions of the calendar, you may need to replace the form on each calendar version.

Final Notes

You do not need to take advantage of OnCore's calendaring capabilities. It is not required. Even if you do use calendars, you are not required to do all of the things we've done.

You do not need to attach/use forms for procedures. Perhaps you are doing an industry study and you will be entering form data in the sponsor’s EDC system, and you have no need to enter it in your local system.

You do not need to define individual procedures/labs/panels. Some customers simply define a generic "Treatment Procedure" and use it for each visit. This will allow you to define a calendar, but not what is being done during each visit.

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Building and Managing Forms in OnCore

Electronic Case Report Forms (eCRFs, or more simply, Forms) can be built in

OnCore and used to record subject information; typically the data recorded in forms is generated by the labs, panels, and procedures of a protocol. eCRFs are most often used in OnCore for investigator-initiated trials, but may be used for other types of trials as well. When OnCore is installed, it is preloaded with a library of forms including the CTMS/Theradex set of forms. OnCore forms can be copied, modified, or deleted to meet individual protocol requirements.

Designing a Form

The following steps outline the process of creating an OnCore form:

1. Decide: Decide which section layout(s) to use.

2. Create: Create the new form, including the necessary fields and option lists.

3.

Set Up: Set up necessary field constraints.

4.

Preview: Test the form in Preview mode to ensure that data entry and constraints flow as expected.

5. Release and Assign Libraries: Release the form and assign to one or more libraries for use in data collection.

In the Form List, clicking a form name link will open an existing form. In the Form

Designer, you can create a new form by clicking the + New Form button, or by using the Create New Version or Save As options.

New forms are created in eCRFs/Calendars > Forms.

The Form List presents a list of all the forms within OnCore. Sort the list by clicking the Name, Version, Status, or Category column headers. You can find existing forms by using the Search box in the top left corner of the Forms List. Use the

Version, Status, and Category Filters on the right to further refine the list. Form categories are used for grouping forms when sorting, filtering the Forms List, and locating forms to be assigned to a Library.

Building and Managing Forms | Page 1 of 53

Can I create new Form Categories?

Yes. Form Categories can be created in Admin > Reference Codes in the CDI

Category domain.

Create a new form

1.

Navigate to eCRFs/Calendars > Forms, and click the + New Form button in the upper right corner of the Form List.

2.

Enter a Name for your form. Include your initials in the name.

3.

Enter a Description for your form.

The description appears in the CRA and Subject Consoles > Forms by Status and Forms by Visit tabs. This field is optional.

4.

Select a Category for your form.

5.

Click Create. The form is created and Form Designer opens.

Navigating the Form Designer

The Form Designer contains information specific to the newly-created form. In the header on the left side are the Name, Version, and Status fields. Located to the right, the Update Status button permits you to move the form through the New,

Completed, Released, and Retired statuses. The Edit Form Details button allows you to change the Name, Description, and Category you specified when creating the form. The drop-down arrow next to the Edit Form Details button includes the options Save As, View PDF, and Delete Form. To return to the list of forms, click the

Form List button.

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The Form Designer is arranged in several tabs:

Design

This tab is where you add sections and fields to your form. You can drag and drop these elements to the desired order. Information specific to the form is presented within this page.

Option Lists

This tab presents a list of all option lists that are associated with the form. It includes the Add Option List button which allows you to create additional option lists.

Constraints

This tab presents a list of all constraints that are associated with the form. It includes the Add Constraint button which allows you to create additional constraints.

Retired

This tab opens when working with Version 2+ of a form. If sections or fields have been retired, they display on this tab; if desired, you can choose to re-activate them.

Info

This tab presents a list of the Form Views associated with the forms, a list of protocols on which the form is used, and the Status History for the form.

Preview

This tab allows you to test data entry and basic constraints prior to releasing the form.

Building and Managing Forms | Page 3 of 53

Choose a section layout

The primary building blocks of a form are sections. A section is a set of fields presented with a certain visual style determined by the layout of the section.

Each form can contain one or more sections. There are four types of sections: list, grid, lab, and matrix. Each type has unique attributes that allow for the capture of different types of data.

Section Types:

List

A series of fields arranged vertically. Fields in the list can be numbered or unnumbered (body measurements, for example).

Grid

A series of fields arranged in a set of rows and columns. Grid sections can be configured to allow multiple records of data to be entered (adverse events, for example).

Lab

A column of pre-defined records followed by fields in additional columns used to capture data (blood chemistry or medical history, for example).

Matrix

A series of fields with a pre-defined set of responses (a diet questionnaire, for example).

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Add a list section

Create a section to capture the data shown below:

1.

Within your form, click

+ Add Section. In the Create Section dialog box, enter:

Title: Body Measurements

Layout: List

Show Title: not selected

Numbering Scheme: Non-Numbered

Notes: leave blank

2.

Click Create. The section is created and you can now add a field.

How do I edit the attributes of a section after I’ve created it?

Click the section’s title to edit the section’s properties if the title is displayed on the page. If the Show Title checkbox is not selected, hover your cursor where the section title would be, and then click the Edit Section button. Hiding the titles of sections can help your form appear seamless, even if you need to build several different sections. If a section’s title is hidden, hover your cursor over the section to see the Edit Section button.

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3.

Click + Add Field. Enter the following in the Create Field dialog box:

Label: Height

Type: Number

Required: selected

Variable Name: Height

Integer Places: 3

Decimal Places: 0

Units: cm

Min: leave blank

Max: leave blank

4.

Click Create.

5.

Repeat steps 2-3 to create the

Weight field, with the following values:

Label: Weight

Type: Number

Required: selected

Variable Name: Weight

Integer Places: 3

Decimal Places: 0

Units: kg

Min: leave blank

Max: leave blank

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IMPORTANT

In order to create the BMI field, your expression must be valid. OnCore must recognize that you are referring to the Variable Names of the Height and Weight fields on your form. To do this, type the first few letters of the variable name (w e i) and then press CTRL + Space Bar. If OnCore finds more than one match, you can choose the appropriate field from the list by double-clicking it or highlighting it and pressing Enter. If OnCore only finds one match, the variable name is automatically completed and becomes green and underlined. This indicates that OnCore has validated the options included in your calculation’s expression.

6.

To create the BMI field, click + Add Field again and enter the following:

Label: BMI

Type: Calculation

Variable Name: BMI

Calculation: round(

Weight /exp( Height /100, 2),1)

7.

Click Create.

The field is created; you can now test the calculation on the Preview tab.

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Use grid sections to collect multiple records of data

Grid sections can be used to collect a single record of data or to collect multiple records of data. Grid sections can be configured to support data collection over a series of subject visits. At the section level, the Logging Style can be set to None,

Carry Forward, or Copy Forward. Within the grid, each field can be configured to

Carry/Copy Forward.

Which logging style should I use?

None

Used when rows of data are collected during a single visit.

Carry Forward

Used when rows of data are collected during a visit and may also include rows collected during previous visits. Rows are included until they are marked as resolved. A row of data is resolved by populating a date field that is designated as the Log Column (Resolved Date/Stop Date). The Log Column is identified by a superscript ‘L’ next to the Field Label. Once a date is entered in the Log Column, the row will not appear on forms for subsequent visits.

Each row is stored in a single place and modifications to the data within any form are reflected in all forms.

Copy Forward

Used when the form is initially populated with data from a previous visit’s form. When a visit’s copy forward form is created, it looks at the previous

visit’s form

, takes a snapshot of the data, and copies it. If the previous form had three rows of data, the newly activated form will be created with three rows of data. Copy Forward forms can expedite data entry by pre-populating values that will remain the same. Fields configured to copy forward are identified by a superscript CF next to the Field Label. Since the data is copied, editing data in one form does not affect the data in another form.

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The table below summarizes the differences between Carry Forward and Copy

Forward sections:

Data storage

Changing data

Carry Forward Copy Forward

Data is stored once when entered. Data is copied when the form is activated.

Data changed on one visit is reflected on all visits with this record.

Data changed on one visit ONLY affects

that visit. For example, if you add data to the Visit 1 form after activating the Visit 2 form, the new data entered on Visit 1 will not copy to Visit 2.

Form characteristics

When data is entered into the Log

Column, the row will not display on forms in future visits.

During form design, individual fields can be configured to copy forward. Data that copies forward can be edited.

Carry-forward fields can be marked Editable or remain readonly

Classic example

Concomitant Medications

Adverse Events

Most like…

Tumor Measurements

Wound Assessments

Project Management

(Tasks are either “Done” and hidden from view, or “In Progress” and still active)

Save As in Microsoft Word

(Once the copy is made, changes to form 1 do not affect form 2)

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Create a carry-forward grid section

Create a new form to capture the data shown below:

1.

Click Form List to return to the list of forms, and then click + New Form.

2.

Enter a Name for your form (use your initials Previous and Concomitant

Medications)

3.

Enter a Description for your form.

4.

Choose an appropriate Category for your form.

5.

Click Create.

The form is created; you will now enter a section.

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6.

Within your form, click + Add Section. Enter the following in the Create

Section dialog box:

Title: Previous and Con Meds

Layout: Grid

Show Title: not selected

Numbering Scheme: Non-numbered

Fields per row: 4

Multiple Rows: select this checkbox

Logging Style: Carry Forward

7.

Click Create. The section is created.

The “Resolved date” field was automatically added to the section because a

Carry Forward section will only work if one field is marked as the Log field; so this field is required.

8.

To change the name of the field, click the Resolved date field label and change it to Stop Date.

9.

Change the Variable Name to Stop_Date.

10.

Select the Allow Approximate Values checkbox and click Save.

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11.

You can now add additional fields within your Concomitant Medications section. Click + Add Field and enter the following in the Create Field dialog box:

Label: Medication

Type: Text

Required: select this checkbox

Variable Name: Medication

Column span: leave as 1

Carry Forward Editable: not selected

Length: 200

Text Type: Multiple Lines

12.

Click Create.

What is the purpose of the Column Span property?

When you created this Grid section, you set the Fields per row attribute to 4, meaning that the first four fields in this section will appear on one row, and then field 5 will start a new row. The only exception to this is a field that takes up more than one column; if you need to allow a large amount of space for a field

(such as a free-text comments field) then you can say it takes up 2 of the 4 columns in the row. The Column span property allows you to customize the look and feel of your form, for readability and ease of use. The Column Span property does not affect the layout of the grid that is created at the bottom of the Grid section when the user records multiple rows of data.

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13.

Repeat steps 11-12 to create the Indication field. All the information to enter is identical except the following:

Label: Indication

Tooltip: Reason for taking

Variable Name: Indication

14.

To create the Dose field, click + Add Field again and enter the following:

Label: Dose

Type: Number

Required: selected

Variable Name: Dose

Carry Forward Editable: not selected

Integer Places: 3

Decimal Places: 0

Units: leave blank

15.

Click Create.

16.

To create the Units field, click + Add Field again and enter the following:

Label: Units

Type: Options

Required: selected

Variable Name: Units

Carry Forward Editable: not selected

List: Click New List

List Type: Form Specific

List Name: Units

Descriptions:

Tablet (code = 1)

Capsule (code = 2)

mg (code = 3)

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mcg (code = 4)

mg/kg (code = 5)

 Click Create

 Make sure your new Units list is selected

Multiple select: not selected

Control Type: Select Box

17.

Click Create.

18.

Repeat steps 16-17 to create the Route field.

This time, you will use an existing domain as the list of choices in this option list field.

 Use a Variable Name of Route.

 When you create your list, choose a List Type of Domain and enter a

List Name of Route.

 Search in the find-as-you-type box for the existing domain called Route.

19.

Repeat steps 16-17 to create the Frequency field.

 Use a Variable Name of Frequency.

 When you create your list, choose a

List Type of Domain and enter a

List Name of Frequency.

 Search in the find-as-you-type box for the existing domain called

Frequency.

NOTE: Use an existing domain instead of a form specific list to save time. You can always build a form-specific list with the values you need for an option list field in your form.

However, if you find yourself creating form-specific lists with the exact same values

(such as Yes/No or Male/Female), it’s a good idea to create a domain with those values and use that same domain across multiple

Want to learn more?

Learn more about creating

Domains and Reference Codes on the Learning Portal’s

Admin/Reference Codes page.

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forms. Keep in mind that changes to the domain will affect all forms in which the domain is referenced.

20.

To create the Start Date field, click + Add Field again and enter the following:

Label: Start Date

Type: Date

Required: selected

Variable Name: Start_Date

Carry Forward Editable: not selected

Allow Approximate Values: selected

21.

Click Create.

22.

To move the Stop Date field to the end of the section, click the Field Label and use your mouse to drag and drop it after the

Start Date field.

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Create a copy-forward grid section

You will now create a new form to capture the data below. The Drug Name and

Planned Dose fields should be configured to Copy Forward because this data will remain the same from visit to visit.

1.

Click the Form List button to return to the list of forms and then click + New

Form.

2.

Enter the following information for your new form:

Name: your initials Dosing and Labs

Description: type any

Category: choose any

3.

Click Create. The form is created and you can now add a section.

4.

Within your form, click + Add Section. Enter the following in the Create

Section dialog box:

Title: Dose Administration

Layout: Grid

Show Title: selected

Numbering Scheme: Continue from Previously Numbered Section

Fields per row: 5

Multiple Rows: selected

Logging Style: Copy Forward

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Why would I set the Fields per row to a number less than the number of fields in the form?

The grid that is created (with all the responses) will show 6 columns across (or however many fields are added to the Grid section). Indicating that the section should have 5 fields per row will put the “If Actual Dose Differs from Planned

Dose…” question on its own line, helping with readability. After you add all 6 fields, you can adjust the fields per row to see how the form will look different, and then decide which setting is the easiest to read.

5.

Click

Create. The section is created and we can now add a field. Within your

Dose Administration section, click + Add Field.

6.

Enter the following in the Create Field dialog box:

Label: Date of Administration

Type: Date

Required: selected

Variable Name: DoseDate

Copy Forward: not selected

Allow Future Values: not selected

Allow Approximate Values: not selected

7.

Click Create.

8.

To create the Time of Administration field, click + Add Field again and enter the following:

Label: Time of Administration

Type: Time

Required: selected

Variable Name: DoseTime

Copy Forward: not selected

9.

Click

Create.

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10.

To create the Drug Name field, click + Add Field again and enter the following:

Label: Drug Name

Type: Text

Required: selected

Variable Name: DrugName

Copy Forward: selected

Length: 50

Text Type: Single Line

11.

Click Create.

12.

To create the Planned Dose field, click + Add Field again and enter the following:

Label: Planned Dose

Type: Number

Required: selected

Variable Name: PlannedDose

Copy Forward: selected

Integer Places: 3

Decimal Places: 0

Units: mg

13.

Click Create.

14.

To create the Actual Dose (Variable Name = ActualDose) field, repeat steps

13-14 but make sure to indicate that this field must be entered at each visit.

15.

Click Create.

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16.

To create the Reason field, click + Add Field again and enter the following:

Label: If Actual Dose Differs From Planned Dose, Provide Reason

Type: Text

Required: not selected

Variable Name: DoseReason

Copy Forward: not selected

Length: 200

Text Type: Multiple Line

17.

Click Create.

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Create a lab section

A lab section allows for collection of data related to a pre-defined list of records.

When creating the section, the list setting determines whether the section is Usage

Specific or uses an Option List. The Usage Specific setting uses the labs listed for the procedure in the calendar to populate the form. An Option List will hard code the values from the selected list in the form.

The first column in the section is always read only and is prepopulated with values from the lab list. Additional fields can be added to capture relevant data and appear in columns to the right of the Lab Name.

You will create a section to capture the data below.

BLOOD CHEMISTRIES

Lab Name

[Usage

Specific]

Collection Date and Time*

Clinically

Significant?*

__/__/____ __ __:__ __ o

Yes o

No

1.

Within your Dosing and Labs form, click + Add Section.

2.

Enter the following in the Create Section dialog box:

Title: Blood Chemistries

Layout: Lab

Show Title: selected

List: Usage Specific

If Yes,

Comments

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IMPORTANT

Usage Specific lab sections can only be used within forms attached to

CRM protocol calendars. This functionality does not apply to forms attached to Registries or those used as Protocol or BSM Annotations.

Lab Name: Chem-20

Variable Name: CHEM20

3.

Click Create.

The section is created and Testing Value appears beneath the Lab Name to indicate that the items in the form will be based on the protocol calendar

(Usage Specific setting). You can now add a field.

4.

Within your Blood Chemistries section, click + Add Field.

5.

Enter the following in the

Create Field dialog box:

Label: Collection Date and Time

Type: Date Time

Required: selected

Variable Name: Lab_Date_Time

6.

Click Create.

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7.

To create the Clinically Significant field, click + Add Field again and enter the following:

Label: Clinically Significant?

Type: Options

Required: selected

Variable Name: CS

List: Click New List

List Type: Domain

List Name: Yes No Character Indicator

Domain Name: Yes/No

 Click

Create and select your new list

Control Type: Vertical Options

8.

Click Create.

9.

To create the If Yes, Comments field, click + Add Field again and enter the following:

Label: If Yes, Comments

Type: Text

Required: not selected

Variable Name: LabComments

Length: 200

Text Type: Single Line

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Create a matrix section

A matrix section presents a series of fields with a standard set of responses. When creating the section, an option list is selected or created. The entries in this option list appear as the response options for each field in the section. All of the fields in a matrix section have a type of Options and a single response can be selected for each field.

You will create a new form to capture the data below. You will need two sections: a matrix section for the Meat, Green Vegetables, Fruits, and Grains fields and a list section for the Total Score field.

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1.

Click Form List to return to the list of forms, and then click + New Form.

2.

In the Name field, type your initials Diet Questionnaire.

3.

Type a Description for your form.

4.

Choose a Category for your form.

5.

Click Create. The form is created and you can now add a section.

6.

Within your form, click + Add Section.

7.

Enter the following in the Create Section dialog box:

Title: Diet Questionnaire

Layout: Matrix

Show Title: not selected

Numbering Scheme: Non-Numbered

List: Click New List

List Type: Form Specific

List Name: Consumption Frequency

Descriptions:

Less than once per week (code = 1, score = 1)

1-3 times per week (code = 2, score = 2)

4-6 times per week (code = 3, score = 3)

Once per day (code = 4, score = 4)

2-3 times per day (code = 5, score = 5)

4-5 times per day (code = 6, score = 6)

More than 5 times per day (code = 7, score = 7)

 Click Create and select your new list.

8.

Click Create. The section is created and you can now add a field.

9.

Within your Diet Questionnaire section, click + Add Field.

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10.

Enter the following in the Create Field dialog box:

Label: Red Meat

Required: Checked

Variable Name: RedMeat

11.

Click Create. Follow the process above to create the following fields:

 Green Vegetables (Variable Name = Veg)

 Fruits (Variable Name = Fruit)

 Grains (Variable Name = Grains) fields.

12.

Next, you will create a list section that includes a calculation for the Total Score field. Within your form, click + Add Section.

13.

Enter the following in the Create Section dialog box:

Name: Total Score

Type: List

Show Title: not selected

Reset Count: not selected

14.

Click Create. The section is created.

15.

To create the Total Score field, click + Add Field again and enter the following:

Label: Total Score

Type: Calculation

Variable Name: SCORE

Calculation: sum(REDMEAT.score,VEG.score,FRUIT.score,GRAINS.score)

16.

Click Create. The section is created and you can test the calculation on the

Preview tab.

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Adding text and headings to sections

Text and headings can be added above, below, or within sections on a form to provide additional information or instruction. The maximum length for text and headings is 4000 characters. Use the arrow next to the + Add Section button to add text and headings above or below a section. Use the arrow next to the + Add Field button to add text and headings within a grid or list section.

Want to learn more?

To learn about the formatting options available within Text and Headings, visit the Form

Details/Design/Free Text

Formatting page on the

Learning Portal.

Can I add instructional text for specific fields?

Yes. There are two options for providing additional information for a particular field:

 Enter information in the Tooltip field within the Create Field window. This text appears next to the field label in grey text.

 Enter information in the Notes field within the Create Field window. This text appears when you hover over the icon next to the field.

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Managing Option Lists

Option lists determine the predefined set of values available for fields with a field type of Options. There are two ways to create new option lists:

1. Click the New List link within the Create Field dialog box; or

2. Navigate to the Option List tab and click +Add Option List.

There are three types of option lists: Form Specific, Domain, and Lab.

Using form-specific lists

Form-specific lists are defined and used within a single form. They are not accessible from other forms. Form-specific lists are useful when the options are unlikely to be used again on a different form. Using a form-specific list provides more control over the list of items.

When creating a form-specific option list, the following fields can be edited:

Description

A free-text description of the option. This field is required and must be 200 characters or less.

Code

A coded value of the option. This value may have some sort of meaning attached to it, or it may simply be used to provide desired sorting. This field is required and must be 30 characters or less.

Score

A numeric value that can be assigned to option list items for use in calculations. This is useful if a numerical scoring scheme is used within the form. This field is optional.

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Using domain lists

Domain lists are based on an existing reference code. In order for a domain to be used in a form, the Available for Clinical Data Capture? field must be set to Yes in

Admin > Reference Codes. These lists reference the existing items within the domain, so if a new value is added to the domain, it will become available within the form. Domain lists are useful if the list of options is standardized or commonly used.

What happens when a reference code is inactivated?

Inactive reference codes are preserved within existing forms. However, the value will no longer be available when making updates to the form or entering data in new forms.

Domain lists do not allow values in the Code or Description fields to be modified.

Those values must be modified via the Admin > Reference Codes menu item.

Using lab lists

Lab lists are based on an existing lab created via the Admin > Labs and Panels menu item. These lists reference the existing items within the lab. If a new item is added to the lab it will be available within the form if the Lab section is not usage-specific.

Lab lists do not allow values in the Code or Description fields to be modified. Those values must be modified by navigating to Admin > Labs and Panels.

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Managing Constraints

A constraint defines a relationship between multiple sections or fields on a form.

Constraints use Boolean logic meaning that the condition evaluates to either true or false.

The Constraints tab presents a list of all constraints associated with the selected form and lets you create new constraints. Constraints can be created and edited when the form status is New.

New constraints are created by selecting the form from the Form List in the eCRFs/Calendars > Forms menu item, navigating to the Constraints tab, and clicking + Add Constraint. The Create Constraint dialog box appears. The following attributes apply to all constraints:

Constraint Type

The type of constraint. The options are Skip Pattern, Option Filter, and

Validation.

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Label

A unique name for the constraint used for reference. This field is required and limited to 100 characters. The label is only visible in the Forms Designer and is meant to be used as a reference by the user managing the constraints.

Expression

The Boolean expression for the constraint. If the expression evaluates to true, the Effect, Action, or Error Message will be applied to the target fields and/or sections. This field is required and limited to 4000 characters.

Targets

The field(s) and/or section(s) to which the Effect, Action, or Error Message is applied.

NOTE: Additional fields appear based on the Constraint Type selected in the Create

Constraint dialog box.

Reference fields and options

To reference a field or option in an expression, press CTRL + Space Bar within the

Expression field to bring up a list of available fields, options, and functions. The section name appears in parentheses after each field. Options are listed in order by field.

Highlight the desired field, option, or function and press ENTER or double-click to bring it into the Expression field. The text becomes green and underlined

to indicate that OnCore has validated your selections.

To reference the Score of an Options field or individual Option, use the dot notation. For example, to create an expression which evaluates to True when the Action field has a score of 5, enter Action.score = 5. When the score property is called on a multi-select field, it returns multiple values. In order to reference the score of multiselect fields, a function must be used in the

Want to learn more?

For additional information on the operators and functions available, visit the Form

Details/Constraints page in the

Learning Portal.

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expression. For example, if the Action field is multi-select, you might create an expression of sum(Action.score) > 5. This would evaluate to True when the sum of all values entered in the Action field is greater than 5.

About skip pattern constraints

A skip pattern alters the applicability of fields or sections within the form based on the evaluation of a logical condition. Selecting a section as the target in a skip pattern constraint has the same effect as applying the constraint to all of the fields in the section.

Targets must occur on the form after the last field used in the expression. You cannot target a field used in the expression or anything that occurs before those fields. When designing the sections and fields of a form, it is important to keep this in mind in order to ensure the field order does not prevent users from creating necessary constraints.

When the Expression evaluates to True, the following Effects can be applied to fields or sections:

Mandatory

The targeted elements will be made mandatory. A red asterisk will appear next to the field/section to indicate that they are now required. The form cannot be saved until all of the mandatory fields have been populated.

Deferred Mandatory

Similar to Mandatory, but enforced when the form’s status is changed from

Started to Completed. The form cannot be marked as Complete until all of the deferred mandatory fields have been populated.

Not Applicable

The targeted elements will be disabled. Any data that was entered into the field will be deleted.

Hidden

The targeted elements will be hidden. Note that the label is still visible, but the data entry field is hidden.

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If multiple skip pattern constraints target the same field, OnCore evaluates the constraints based on the specified effect. The following precedence is applied:

1. Mandatory

2. Deferred Mandatory

3. Not Applicable

4. Hidden

So, if Constraint A has an effect of mandatory and Constraint B has an effect of hidden and both target the same field, the target field becomes mandatory, not hidden when both constraints evaluate to True.

You will create a skip pattern constraint on our Dosing and Labs form to make sure that a Reason is provided when the Actual Dose differs from the Planned Dose.

Create a skip pattern constraint

1.

Within your Dosing and Labs form, go to the Constraints tab.

2.

Click the + Add Constraint button and enter the following:

Constraint Type: Skip Pattern

Label: If Planned Dose is not equal to Actual Dose, Reason must be provided.

Expression: PlannedDose <> ActualDose

Target: DoseReason

Effect: Mandatory

3.

Click Create. The constraint is created and we can test it on the Preview tab.

NOTE: Use constraints to conditionally require or validate fields. When building a form, you have the ability to mark individual fields as

Required and there is some built-in data validation for certain field types:

 Date and Time fields will only accept properly-formatted values

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 Number fields can be limited by Min and Max values

Use constraints when the logic required is more complex than what you can achieve with field-specific settings. The skip pattern constraint explained previously is a great example – the Reason field should not be marked

Required when building the form; it should only be required if the Actual and

Planned Doses do not match.

About option filter constraints

An option filter limits the choices that are available for subsequent options fields based on the evaluation of a logical condition. All fields with a Type of Options can be targeted. Multiple options fields can be selected as targets if all of the fields use the same option list. Sections cannot be targeted.

The following actions can be applied to options fields:

Include

Only the options selected in the options field will be available for the target field(s).

Exclude

All options except those selected in the options field will be available for the target field(s).

If multiple option filter constraints target the same field and evaluate to true, OnCore will apply all of the specified actions.

Can an option filter constraint be used to limit the values available from a domain?

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Yes! To limit the options available every time the form is used, create a constraint with Expression of “true” (must be lower-case) and specify the values to be included or excluded. To limit the options available for the form when used for a specific protocol, create the constraint within eCRFs/Calendars > Specifications > select

your protocol > Calendar > select your form > Form Customization > Constraints.

NOTE: When using option filter constraints to limit the values available from a domain, it’s best to use an Action of Include. This ensures that values added to the domain do not appear in your form unexpectedly.

You will create an option filter constraint on our Previous and Concomitant

Medications form to make sure that the options for Route are appropriate based on the value entered for Units.

Create an option filter constraint

1.

Within your Previous and Concomitant Medications form, open the

Constraints tab.

2.

Click the + Add Constraint button and enter the following:

Constraint Type: Option Filter

Label: If Units = Tablet or Capsule, Route must be Oral

Expression: Units in (Tablet, Capsule)

Target: Route

Action: Include

Options: Oral

3.

Click Create. The constraint is created and we can test it on the Preview tab.

When does a constraint require the use of the in operator instead of the equals operator?

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When your constraint expression is evaluating a multiple-select options field, use the in operator. When your constraint expression is evaluating a single-select options field for the presence of a single value, use the equals operator. When your constraint expression is evaluating a single-select options field for the presence of any one of a list of options, use the in operator. In the example previously, we used the in operator so the constraint would evaluate to true when the Units field was equal to either Tablet or Capsule.

About validation constraints

A validation can be used to enforce logical consistency between fields based on the evaluation of an expression. When the expression evaluates to true, an error message appears. If the validation constraint is not deferred, the form data cannot be saved until the issue is resolved. If the validation constraint is deferred, the form data can be saved, but the form status cannot be changed to Completed until the issue is resolved.

The expression is evaluated once all of the fields used in the expression are populated. When data in one of the fields is modified, the error message will appear if the expression evaluates to true and disappear if the expression evaluates to false.

Any fields used in the expression can be selected as the target. At least one field must be selected. If multiple validation constraints target the same field and evaluate to true, OnCore will display all of the specified error messages.

The following attributes apply to validation constraints:

Error Message: The message to appear on the form under the Target field(s) when the expression evaluates to true. This field is required and limited to

1000 characters.

Deferred - If the checkbox is selected, the validation occurs when the form status changes to Complete. Until the form is completed, the error message appears in yellow text instead of red.

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Create a validation constraint

1.

Within your Previous and Concomitant Medications form, open the

Constraints tab.

2.

Click the + Add Constraint button and enter the following:

Constraint Type: Validation

Label: Start Date must be less than or equal to Stop Date

Expression: Start_Date > Stop_Date

Targets: Start_Date, Stop_Date

Error Message: Start Date is greater than Stop Date. Please verify both dates.

3.

Click Create. The constraint is created, and we can test it on the Preview tab.

IMPORTANT

Deferred validation constraints can only be used within forms attached to CRM protocol calendars. This functionality does not apply to forms attached to

Registries or those used as Protocol or BSM Annotations since there is no

Completed status for these forms.

Let’s create a Validation constraint on our Previous and Concomitant

Medications form to make sure that the Start Date is less than or equal to the

Stop Date.

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Edit a constraint

After a constraint has been created, click the Edit link to make changes if the form status is New. The Constraint Type cannot be modified. If the wrong Constraint

Type was selected, click the Edit link, and click Delete to delete the constraint. A new constraint of the correct type can then be created. If the form status is

Completed or Released, constraints cannot be modified or deleted. In order to make changes the form status must be returned to New, or a new version of the form must be created.

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Understanding OnCore’s Expression Language

The expression language is used for both calculation fields and constraints.

Calculation expressions evaluate to a number. Constraint expressions evaluate to

True or False.

Use a valid operator

Operators are either binary (applied to two operands) or unary (applied to a single operand). The following operators are supported:

Operator Description

+

-

*

/

+

-

!

%

<

>

<=

>=

= or ‘equals’

<> Or ‘not equals’

Not

Percent*

Positive

Negative

Multiply

Divide

Add

Subtract

Less Than

Greater Than

Less Than or Equal To

Greater Than or Equal To

Equal To

Not Equal To

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Type

Binary

Binary

Binary

Binary

Binary

Binary

Binary

Unary

Unary

Unary

Unary

Binary

Binary

Binary

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Operator Description Type

&& or ‘and’

|| or ‘or’ in not in

Evaluates to True if both operands evaluate to

True

Evaluates to True if either operands evaluate to

True

Evaluates to True if the option is in the list

Evaluates to True if the option is not in the list

*

The % operator can be used on literal number values only.

Binary

Binary

Binary

Binary

The order in which operators are evaluated, known as precedence, is as follows:

1. Property Selector (.)

2. Unary Operators (%,!,+,-)

3. Multiplication/Division (*, /)

4. Addition/Subtraction (+, -)

5. <, >, <=, >=, =, <>

6. and, or

Use a valid function

The following functions are supported in the Expression Language:

Function Name Description Format avg sum min max

Average of multiple values

Sum of multiple values

Minimum of multiple values

Maximum of multiple values avg(Number x, Number y, …) sum(Number x, Number y, …) min(Number x, Number y, …) max(Number x, Number y, …)

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Function Name exp round floor ceiling daysBetween

Description Format

Raise the value to a power exp(Number x, Number y,…)

Round a value half-up to the decimal place precision specified roundup(Number value,

Number decimalPlace)

Round a value down to the decimal place precision specified floor(Number value, Number decimalPlace)

Round a value up to the decimal place precision specified ceiling(Number value,

Number decimalPlace)

Days between two dates daysBetween(Temporal date1, Temporal date2)

monthsBetween now isBlank isNotBlank

Months between two dates monthsBetween(Temporal date1, Temporal date2)

Returns the current date now()

Returns TRUE if the value is null isBlank(Field)

Returns TRUE is the value is not null isNotBlank(Field)

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Using literals in an expression

Literals are hard-coded values used in an expression. Literals can be numbers or text. Text must be entered in double quotes and is case-sensitive. For example, when an expression of EventDescription = "Headache" is evaluated, the constraint will be triggered if ‘Headache’ is entered, but not if ‘headache’ is entered.

Consider using the OR operator to account for all possible user entries. If a user might enter “Headache,” “headache,” or “head ache” in a free-text field that you want to use in a constraint, your expression might be EventDescription =

“Headache” or EventDescription = “headache” or EventDescription = “head ache”.

Referencing application-specific parameters

Expressions can be written to compare values in a form field to other dates in

OnCore. To reference these dates, use param(“X”) where X is a string that is known by OnCore. The following dates can be referenced as parameters:

 VISIT_DATE

 CONSENTED_DATE

 ON_STUDY_DATE

 ON_TREATMENT_DATE

 ON_ARM_DATE

 OFF_ARM_DATE

 OFF_TREATMENT_DATE

 ON_FOLLOW_UP_DATE

 OFF_STUDY_DATE

If, for example, Adverse Events should not be recorded prior to Consent Date, a

Validation Constraint could be created with the following expression:

OnsetDate < param("CONSENTED_DATE")

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NOTE: Constraints that use application-specific parameters cannot be tested in the

Form Designer. Instead, the form must be attached to a calendar and filled out for a subject in order for the constraints to be evaluated against the Subject Console/Visit data.

Managing Form Statuses

Forms can have a status of New, Complete, Released, or Retired. Changes can only be made to a form when it has a status of New. In order for a form to be attached to a protocol calendar they must have a status of Released and, in an

Enterprise OnCore environment, be included in at least one library.

Editing a new form

Initially a form has a status of New, indicating that it is in progress. Only forms in the

New status can be deleted or modified in the following ways:

 Sections can be added, edited, or deleted

 Fields can be added, edited, or deleted

 Fields can be retired (Version 2+ or forms created using Field Sets)

 Fields can be rearranged using drag and drop

 Option lists can be added, edited, or deleted

 Constraints can be added, edited, or deleted

Completing a form

When editing is complete, the form status can be changed to Completed, which indicates that the form is ready to be reviewed. To complete a form, you would click

Update Status and select Move to ‘Complete’ Status. If additional updates to the form are required, click Update Status again and select Move to ‘New’ Status. The form is reverted to New status and can be edited or deleted.

The following screenshot shows where the status is updated from New to Complete:

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Releasing a form

The final step in creating a new form is to release it. After a form has been released, it is locked and available to be included in libraries (Enterprise OnCore environment) and added to protocol calendars (Cancer Center OnCore environment). To release a form, click Update Status and select Move to ‘Release’

Status.

Retiring a form

If a form will no longer be used, its status can be changed to retired. Retired forms cannot be added to calendars, but retired forms on existing calendars can still be used for subject data entry. To retire a form, click Update Status and select Move to

‘Retire’ Status.

NOTE: Once the form is attached to a specification or assigned to a library, the transition back from Released to Completed is not allowed. If the form has not yet been used, it can be removed from the specification and/or library.

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Creating New Form Versions vs. Using Save As

When changes are required for an existing released form that is already in use for a protocol, a new version of the form can be created. You can make a new version of a form by selecting New Version from the drop-down next to the Edit Form Details button within your form. Doing so allows you to add, edit, or retire fields and sections, add or edit options lists, and add or remove constraints. You can then upgrade to the new version of your form within your protocol calendar.

NOTE: Data for fields retired in a subsequent version of the form will no longer appear in the application or in the Data Export once the form is upgraded on the calendar. Data for retired fields can be retrieved by querying the database view for the form, if necessary.

Want to learn more?

If you need a form that is similar to one that you have already built, you can use the Save As option available in the drop-down next to the Edit

Form Details button. You can assign a new name to the form and make any necessary changes in the new form without affecting the original.

For additional information about the use of New Version vs Save As, see the

Form Details/Design page of the Learning Portal.

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Viewing Additional Form Information

The Info tab displays the Reporting Views generated for the form, the protocols on which the form is used, and the status history for the form.

When are form views generated?

Views are generated based on a scheduled process once the form is released and either assigned to a library as the protocol annotation form or assigned to a procedure within a calendar. Views created for the Protocol Annotation context begin with ‘SV_AN_PCL’ while views created for the Subject Visit context begin with

‘SV_CDI’.

Assigning Forms to Libraries

In order to use a form in a protocol calendar, the form must be assigned to the protocol’s library. Forms are assigned to Libraries via the Admin > Group Admin >

Libraries page.

In an Enterprise OnCore environment, a released form must be added to at least one library before it can be added to a protocol calendar. A form can be added to multiple libraries, if needed.

NOTE: In a Cancer Center environment, there is only one (hidden) library, so a released form is automatically added to that library and is immediately available for use in protocol calendars. Form builders in Cancer Center environments will not see the Admin > Group Admin > Libraries menu item.

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Reference

Section attributes

The following table lists the attributes we’ve seen as we created the sections above.

Section

Type(s)

Attribute Description

All

All

Title

Layout

The name of the section. This field is required. Section titles must be 4000 characters or less.

The layout of the section. Options are List, Grid, Matrix, and

Lab.

All Show Title If the checkbox is selected, the value entered in the Title field will appear at the top of the section within the form. If the checkbox is not selected, the Title will be hidden.

All Notes

Grid, List,

Matrix

Numbering

Scheme

Allows the user to decide how a form section will be numbered. If ‘Continue From Previously Numbered Section’ is selected, field numbering will continue from the previous section. Selecting ‘Reset Count’ will cause the field numbering to reset and start over at 1. Sections with ‘Non-

Numbered’ selected will not be numbered.

Grid Fields per

Row

Free text information about the section. This field is optional and must be 4000 characters or less.

The number of fields to show, per display row, in the data entry portion of the grid section. Valid values are 1 - 6.

Grid Multiple

Rows

If the checkbox is selected, the Grid section will allow multiple records of data to be entered. If the checkbox is not selected, a single record of data is allowed.

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Section

Type(s)

Attribute

Grid

Matrix

Lab

Lab

Description

Logging

Style

Allows for data collection across multiple visits in sections with Multiple Rows. Options are None, Copy Forward, and

Carry Forward. For more information, see the Grid Section

Logging Styles description above.

List

List

Select or create an Option List to be used in the section. The entries in this Option List appear as the response options for each field in the section.

Select Usage Specific to create a generic lab form that can be used for different lab procedures. If an Option List is selected or created, each entry in the list appears as a row in the section’s display.

Lab Name Text entered in this field appears in the first row of the first column of the section and is read-only.

Lab Variable

Name

Enter a variable name for the option list. Used to reference the lab Option List in the expression language.

Field types

The following list describes the field types that can be created within list, grid, and lab sections. Note that all fields in a matrix section have a type of Options.

Attachment

Allow users to upload documents or add a link to a document hosted somewhere on their Intranet or the Internet.

Calculation

Not directly editable by the user. Instead, the value is derived by a mathematical expression using inputs from other fields in the form. The expression is evaluated once all of the input values have been entered.

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Calculation fields must result in a numeric value. The Calculation field must be located after all of the fields used as input values.

Date

Date fields use the MM/DD/YYYY format.

Date Time

Date Time fields add a Time component to the Date field, allowing users to specify Hours and Minutes in the HH:MM format. If the time is not specified it defaults to midnight (00:00).

Duration

Duration fields allow users to enter elapsed time in Hours, Minutes, and

Seconds in the HH:MM:SS format. The maximum value that may be entered is '99:59:59'.

Number

Number fields accept numeric values.

Options

Options fields present a predefined list of values.

Text

Text fields allow for entry of free text.

Time

Time fields allow the user to specify a time of day with Hours (24) and

Minutes. Time values can be typed in the HH:MM format or the time picker can be used to select the hour (00-23) and minute (presented in 5 minute increments).

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Field attributes

The following table describes additional details related to the field types above.

Field Type Attribute

All

All

All

All

All

All

All (Carry

Forward Grid

Sections Only)

Description

Label

Type

The label of the field, which appears next to the field in the form. This field is required and is limited to 4000 characters.

The data type of the field being created.

Required

Tooltip

If the checkbox is selected the field must be populated when the form is saved.

Help text available within a form, which appears next to the field label or via hover. This field is optional and is limited to 1000 characters.

Variable Name A short, program and database friendly name to assign to the field. This will be used when generating reporting views and exporting data for analysis. Because this field is intended for use in programs and analysis, certain constraints are applied:

 Must start with a letter

 May only contain letters, numbers, and underscores

 Must be a unique value within the form

 Must not be an Oracle or SAS reserved word

Notes

Carry Forward

Editable

This field is required and limited to 30 characters.

Free text information about the field. This field is optional and must be 4000 characters or less.

If the checkbox is selected, the field can be edited when data have been carried forward. If the checkbox is not selected, the field will be read-only.

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Field Type Attribute

All (Copy

Forward Grid

Sections Only)

Copy Forward

Attachment

Calculation

Date, Date

Time

Date, Date

Time

Allow URLs

Calculation

Allow Future

Values

Allow

Approximate

Values

Description

If the checkbox is selected, data in the field will be copied forward to subsequent visits. If the checkbox is not selected, the data in the field must be entered at each visit.

If the checkbox is selected, users will be able to enter links (URLs) as attachments instead of uploading a document.

A mathematical expression that results in a numeric value.

If the checkbox is selected, future values will be accepted. If the checkbox is not selected, only values on or before the current date are acceptable.

If the checkbox is selected, full dates are not required. Instead, users can specify any known portion of the date: Month, Day, or Year. In addition, the following changes are applied:

 Options for Unknown (Unk), Not

Applicable (NA), Not Legible (NL), and

Ongoing (Ong) are available. Values of

‘unk’, ‘unknown’, ‘ong’, ‘ongoing’, ‘nl’, ‘not legible’, ‘na’, ‘n/a’, and ‘not applicable’ are also accepted.

 Dates in the format of 12/2012 or

12/00/2012 may be entered to indicate that month and year are known, but the day is not known. Dates in the format of 2012 or

00/00/2012 may be entered to indicate that only the year is known. If the short version of the date is entered, it will automatically be formatted in the long format after leaving the field.

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Field Type Attribute

Number Integer Places

Description

The number of digits that may occur before the decimal place. This field is required and the maximum length is 10.

Number

Number

Number

Number

Number (Lab

Sections with

Usage Specific or Lab Option

List Only)

Decimal Places The number of digits that may occur after the decimal place. This field is required and the maximum length is 5.

Units The units in which the value should be expressed.

Available options are the values in the Unit of

Measure reference code.

Min

Max

Lab Value

The minimum value that may be entered in the field. If the value entered is less than the value in

Min, a warning message appears, but the value can be saved.

The maximum value that may be entered in the field. If the value entered is greater than the value in Max, a warning message appears, but the value can be saved.

If the checkbox is selected, the Integer Places,

Decimal Places, Units, Min, and Max attributes are hidden and the constraints and Units defined in Admin > Labs and Panels > Items will be used.

If the checkbox is not selected, the settings in

Admin > Labs and Panels will not be used and must be defined using the attributes described above.

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Field Type Attribute

Options

Options

Options

Options

Text

List

Description

The name of the Option List. Option Lists can be created via the New List link in the Create Field dialog box, or on the Option Lists tab of the Forms

Designer. Each entry in the Option List appears as a radio button or an entry in the drop-down list depending on the Control Type setting.

Multiple Select If the checkbox is selected, more than one Option

List value can be selected when entering subject data into the field.

Control Type If Select Box is selected, the values in the Option

List appear in a drop-down list. If Vertical Options is selected, the values in the Option List appear as a vertical list of radio buttons (single select) or checkboxes (multiple select). If Horizontal Options is selected, the values in the Option List appear as a horizontal list of radio buttons (single select) or checkboxes (multiple select).

Cascade From This attribute is visible if the selected option list uses a Domain with a parent category and that parent category is used by another field on the form. Select the appropriate field using the parent list in order to filter the values in the current

Options field based on the selection in the field using the parent option list.

Length The maximum number of characters that may be entered into the field. This field is required and must be equal to a number between 1 and 4000.

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Field Type Attribute

Text Text Type

Description

The entry mode for the text field.

 Single Line allows the user to enter a single line of text. This mode is ideal for shorter amounts of text.

 Multi Line allows the user to enter multiple lines of text. This mode is ideal for longer amounts of text.

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Reporting and Searching

Using Protocol Search

Protocol Search is a robust searching tool that allows you to specify a wide variety of search criteria and to choose additional protocol data to appear in the search results. You can export those results to a PDF report or Excel spreadsheet.

Conduct a protocol search

1.

Navigate to Protocols > Protocol Search.

As you can see, the Protocol Search page provides dozens of data fields, allowing for complex and detailed searches.

2.

In the Protocol Status section, locate the Pending, Active, and Completed checkboxes. These checkboxes refer to the current status of the protocol:

 Pending: Includes the statuses of New, PRMC Approval, IRB Initial

Approval, On Hold, and all Protocol Signoffs

 Active: Includes the statuses of Open to Accrual, Suspended, and

Closed to Accrual

 Completed: Includes the statuses of Abandoned, Terminated, and IRB

Study Closure

3.

Select the

Completed checkbox and click Search. The Protocol Search

Results page appears with your search criteria listed in the page header.

Reporting and Searching | Page 1 of 12

Understanding the Protocol Search Results page

The Protocol Search Results page always includes the following features:

Search criteria Your search criteria are always listed in the page header.

If you export the results via Excel or PDF, the search criteria are included in the export.

Filter and navigational aids

Results table

The Filter field allows you to limit the results; type a search term and press Enter to show only protocols with matching criteria in any of the columns. The Page number drop-down allows you to open a specific page of the results, and the arrows allow you to navigate between pages.

The search results are shown in a table that includes a standard set of results fields along with any additional results columns you have selected. To sort the data, click a column header; click again to sort in the opposite order.

Protocol No. column

Protocol Count

For users with access to the PC Console, the protocol numbers are links to the corresponding protocol.

At the bottom left of the search results page, the total number of results found is shown.

View Excel

View PDF

Add Staff button

Generates an Excel spreadsheet of the search results.

Generates a PDF document of the search results.

Allows you to add staff to a protocol directly from the protocol search results. Select the corresponding checkbox in the Add Staff? Column, and then click Add

Staff. A pop-up window opens with fields for Staff Name,

Staff Role, and Start Date.

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Add result columns to your protocol search

The Protocol Search page is divided into expandable sections. Each section has a header with an expand icon [+] and a section name; when you click [+], additional options appear.

On the left of each section is a column of checkboxes labeled “Result Column?”

Selected fields are included as columns on the search results page.

The following steps will add criteria to your previous search of Completed protocols so that you will see only Phase II studies. We will also add a result column so that you can view the Protocol Type for each protocol listed.

1.

Click Back to Search to return to the Protocol Search page.

Note that the criteria used in the last protocol search are automatically entered in the data fields. If you wanted to clear all criteria used in your previous search, you would click Clear. In this case, we will retain the criteria and add to it.

2.

Click [+] to open the Main section. You will see a list of fields related to the

Main tab of the PC Console.

3.

In the Main section, click in the Phase field and select II (for Phase II).

NOTE: Like most fields in Protocol Search, Phase is a multi-select find-as-youtype field. These fields allow you to choose multiple options for complex searches.

4.

Select the Result Column? checkbox for Protocol Type.

5.

Click Search.

In the Protocol Search Results page, the header indicates that this is a list of

Phase II protocols that have a status of Completed (Abandoned, Terminated, or IRB Study Closure). A column for the Protocol Type is now included in the results table.

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Conduct a protocol search using date ranges

Searches using date ranges can be more complicated. In the Protocol Status section, for example, the Status field requires that you first choose a status, and then enter date criteria as follows:

 To match protocols having the selected status within a specified date range, enter both a From Date and a Thru Date.

 To match protocols having the selected status at any time after the From

Date, leave the Thru Date blank.

 To match protocols having the selected status at any time prior to the Thru

Date, leave the From Date blank.

The following instructions show you how to limit your previous search to only those protocols that were Open to Accrual at some point in the last year.

1.

Click Back to Search to return to the Protocol Search page. The search criteria entered from the previous search should still be in place; do not clear your selections.

2.

In the Status field, select Open to Accrual from the drop-down list. In the corresponding date fields, type the following date shortcuts:

From Date: y-1 (indicating one year prior to today’s date)

Thru Date: t (indicating today’s date)

3.

Click Search.

Your previous search of Phase II, Completed protocols is now limited to only those that were Open to Accrual at some point in the prior year.

You can conduct other protocol searches using date ranges. The Status Change field functions similarly to the Status field. This option finds protocols for which the status changed to the selected status at some point during the specified date range.

The Accrual section of Protocol search also uses date ranges. You can choose to see accrual grouped by all affiliates, the Research Center, and/or the VA. Specify a

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Section Title | Page 4 of 12

date range in the From Date and Thru Date fields to limit the accrual period

(otherwise, the lifetime protocol accrual is shown).

Save a protocol search

You can save protocol search criteria to perform search more efficiently. After you have developed and tested searches that you know you will use frequently, you can save the search to run it again without having to reenter all the search criteria.

NOTE: Any dates that have been entered as part of the saved search are saved as the calendar date and not a relative date. Date entries using shortcuts such as “yb” are not re-evaluated each time a saved search is selected

.

1.

Click Back to Search to return to the Protocol Search page.

2.

At the top of the page, click the Save As… button.

3.

In the pop-up window, type a name for your search in the

Name field and click

Save.

Your saved searches will be available in the drop-down list attached to the

Saved Searches field. They will also appear in the Saved Searches widget on the Home page.

Reporting and Searching | Page 5 of 12

Using Document Search

Document Search allows you to easily locate protocol documents. Document

Search locates files that have been attached in one of the following locations:

 PC Console > Documents/Info > Attachments tab

 IRB or PRMC/SRC Reviews (if marked as Released)

 PC Console > Institution > selected institution > Documents

NOTE: Document Search displays documents only from active protocols; that is, protocols with a status of Open to Accrual, Closed to Accrual, or Suspended.

Documents associated with inactive protocols cannot be found using Document

Search.

Document Search criteria

Search criteria are entered in Protocols > Document Search. You can use any of the options, alone or in combination, to narrow results.

Protocol No.

Keyword

Searches only active protocols (status of Open to Accrual,

Closed to Accrual, or Suspended).

Text entered in this field will look for matches in the Title,

Short Title, or Objective fields in the PC Console > Main >

Details tab.

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Investigator

Institution

Display All

Documents

Matches protocols with the specified Investigator listed in the PC Console > Main > Staff tab > Protocol Staff section.

Matches protocols having the specified institution as a

Participating Institution in PC Console > Institution.

NOTE: Institution is required and will default to the institution to which your user record is associated. You can only select those institutions to which you have access.

A protocol may have multiple versions of a document. By default, only the most recent version of a document appears in the search results. When the Display All

Documents checkbox is selected, all versions of matching protocol documents will be listed.

NOTE: The presence of this checkbox is controlled by a configuration option and may not be available in your system.

Conduct a document search

1.

Navigate to Protocols > Document Search.

2.

In the Keyword field, type tumor and click Submit.

The Document Search Results page opens, displaying all documents from protocols in which the word “tumor” is found in the Title, Short Title, or

Objective field. The next section explains the layout of the results page.

Reporting and Searching | Page 7 of 12

Understanding the Document Search Results page

Document Search results show only protocols that have documents matching the search criteria. Search results are sorted by Protocol No., Document Type, and then by Version Date in reverse chronological order. The Alt. Protocol No. column displays the protocol’s IRB, PRMC, and Sponsor Protocol numbers.

The File Name is a link that, when clicked, downloads a copy of the attached document. When a consent attachment has been uploaded as a combined consent, the File Name column shows text that references the original document. The original document appears as a link, from which all parts of the combined consent can be downloaded.

The Version Date column shows the dates for expired documents in red, when

OnCore is configured to do so.

What security features affect Document Search results?

Search results are limited by both your institution and the scope of your privileges. If your staff record is associated with the Office of Clinical Trials or the Research

Center, search results include documents from the PC Console > Documents/Info >

Attachments page. Otherwise, you will see documents that have been uploaded to your institution's Documents page. The privilege that controls Document Search can further limit access by Organizational Unit, Department, Management Group, or assignment as staff on the protocol.

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Section Title | Page 8 of 12

Reporting

OnCore provides many standard reports that have been developed in collaboration with our customers.

You can also upload custom reports to run in

OnCore, which is covered in detail in the

Jasper Reports Administration training session.

The following instructions show you how to run one common report: the Planned Visits

Report.

Note to Oncology users

See the Learning Portal’s

Accrual Monitoring

Reports/Oncology Only page for detailed Data Table 3 and 4

Reporting options. OnCore provides Data Table 3 protocol and subject discrepancy reports that identify data gaps, which allows you to ensure the accuracy of your reporting.

Generate a Planned Visits Report

The Planned Visits Report displays a list of subject visits for a date range and can be filtered by Protocol, Procedure, Subject Staff, Organizational Unit, and

Management Group.

1.

Navigate to Reports > Reports and click the Planned Visits tab.

2.

In the Standard Reports section, click the Planned Visits Report link. The

Planned Visits Report criteria page opens.

3.

Enter the following criteria:

Visit Date From: 2/20/2013

Visit Date Thru: 2/20/2014

Protocol No: CARD0815

Organizational Unit: Medical School

4.

Click Submit.

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The results display all visits for the protocol during the specified date range.

The link in the Visit Info column opens the Subject Visit Update page, where you can verify the visit and enter visit information.

Using Consoles to View Aggregate Data

OnCore provides several consoles that aggregate data relevant to various user groups. This training manual shows how to use the Accrual Monitoring Console and the DSMC Console.

View data in the Accrual Monitoring Console

The Accrual Monitoring Console provides an easy way to view protocol accrual information categorized by Oncology Group or Department, Management Group,

Principal Investigator, or Subject Staff.

1.

Navigate to Reports > Accrual Monitoring.

The top of the page displays the From Date and Thru Date fields. The left side of the page shows four categories: Department, Management Group, Principal

Investigator, and Subject Staff. The tabs and search fields within each category represent different reports. When you open the Accrual Monitoring Console, it opens to the Department > By Scope tab.

You must enter dates in both fields before any data is displayed.

2.

In the From Date field enter y-2. In the Thru Date field enter y-1, and then click Refresh.

NOTE: Any time you change the date range or select/deselect the Therapeutic

Protocols Only checkbox, you must click the Refresh button to perform a new search.

3.

Click the By Scope tab in the Management Group section.

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Section Title | Page 10 of 12

The results list the number of protocols and accruals during the specified range. The results are categorized by the scope (as defined in the

PC Console > Main > Details tab), and they are then further categorized for each Management Group.

NOTE: When searching by Management Group, a protocol is identified only by its primary Management Group.

4.

Click the By Sponsor Type tab in the Management Group section.

The results are categorized by the type of principal sponsor (as defined in the

PC Console > Main > Sponsor tab) and are then further categorized for each

Management Group.

5.

On the Management Group tab in the Protocol Accrual For find-as-you-type field, select Cardiology.

The results display all protocols with a management group of Cardiology that were open to accrual in the date range. In this report, individual protocols are listed along with the following accrual information:

Summary Accrual section

Period Summary

Accrual section

Period Accrual section

Displays the accrual counts for this protocol during the entire time the protocol has been open up to the time the report is run (not just for the date range entered).

Displays the accrual counts for this protocol during the selected time period.

Displays the accrual counts by month during the selected time period.

NOTE: Those protocols marked as Summary Accrual

Info Only in PC Console > Main > Details will not show accrual counts in this section because the accruals are entered over a variable timeframe.

Reporting and Searching | Page 11 of 12

6.

Export the search results by selecting one of the buttons located at the bottom of the page.

 View Excel: Creates an Excel spreadsheet of the search result data.

 View PDF: Creates a PDF document of the search results.

 View Chart: Displays a bar chart of the results. (The bar chart is a configuration option that may not be available in your system.)

View data in the DSMC Console

The DSMC Console allows Data Safety Monitoring Committee members to easily review protocol data. You can view and export consolidated protocol data and subject safety information, such as serious adverse events and deviations.

1.

Navigate to

Reviews > DSMC Console.

2.

In the Select Protocol field, select your protocol: PROT-your initials.

The DSMC Console displays information specific to the selected protocol. Click each tab to display protocol information. Certain information is only aggregated in the DSMC Console, such as the Accrual History, Disposition, Baseline

Demographics, Response, and Survival/TTP tabs.

The Export tab allows you to select a set of data to export to an RTF (Rich Text

Format) document, which you can open in Microsoft Word.

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Section Title | Page 12 of 12

4/15/2015 Personalization and Home Screen Configuration - OnCore Documentation

Personalization and Home Screen Configuration

Alternate Versions

13.5 13.0

edit

Page Contents

1 Home Screen and Widgets

1.1 Bookmarks

1.2 Adding, Positioning, and Removing Widgets

1.3 Configuring Widgets

2 Protocols Widget

2.1 Protocol Selection – Configuring the Watch Tab

3 Subjects Widget

3.1 Subject Selection – Configuring the Watch Tab

4 SAEs Widget

4.1 SAE Selection – Configuring the Watch Tab

5 Registration Widget

5.1 Configuring OnCore Registration

6 Reports Widget

7 Saved Searches Widget

8 Announcements Widget

Home Screen and Widgets

After logging into OnCore, you are presented with your Home screen, also known as your dashboard. The Home screen may be customized to display widgets. A widget is a personalized display of OnCore data, and contains links allowing you to quickly access that data. Widgets will only display data that you have the appropriate privileges to view.

OnCore provides widgets for Protocols, Subjects, SAEs, Reports, Registrations, and saved Protocol Searches. Depending upon your needs, you may add one or more of these widgets to your Home screen.

In addition, an Announcements widget is automatically displayed for all OnCore users, unless they are affiliate users using the Network

Portal (the Network Portal takes precedence over the Home screen).

Bookmarks

Some widgets display bookmarked protocols and subjects. Bookmarking is a simple way for you to indicate the data that is most important to you.

To bookmark a protocol, display the protocol in the PC Console, then click the star icon in the upper left corner:

When the Protocol is bookmarked, the star will be an amber color.

To remove a bookmark from a protocol, click the amber star. The icon will turn white. Bookmarks may also be removed via the

Bookmarks tab that is displayed when configuring widgets (see the Configuring Widgets section below).

To manage bookmarks for a subject, display the subject in the Subject Console and follow the same procedures.

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Adding, Positioning, and Removing Widgets

To begin your Home screen customization, you must display your Home screen by clicking on the Home link found at the upper right of all OnCore pages.

When viewing your Home screen, the ‘gear’ icon is shown next to the Home link:

Clicking the ‘gear’ icon launches the Home Screen Configuration page. The Widgets vertical tab will be highlighted, and your widget configuration will be shown in the main body of the page. Here is an example:

Widgets listed in the white boxes display on the left (column 1) or right (column 2) of the Home screen. Widgets listed in the table at the bottom have not been selected for display.

To add an unselected widget to your Home screen, select its corresponding Add checkbox and click the Save button. The widget will disappear from the table and display in either ‘column 1’ or ‘column 2’.

After a widget is added to the Home screen, additional configuration may be required before the widget displays data. This is discussed in the Configuring Widgets section found later in this document.

A widget’s position on the Home screen can be changed by clicking the widget name within one of the columns and using the green arrows to modify the Home screen layout:

To remove a widget from your Home screen, click the widget name shown in one of the columns, then click the Delete button that appears.

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Clicking on the Home link will return you to the Home screen:

At the upper right of every widget is the delete icon. 

 

You may use this icon to remove the widget from your Home screen.

Configuring Widgets

When you configure a widget, you specify which data you wish to see. The Protocols, Subjects, SAEs, and Registration widgets will not display OnCore data until they are configured. (The Saved Searches and Registration widgets are preconfigured.)

Widget configuration is done via the gear icon found at the upper right of the widget. Clicking the gear icon displays a pop up that contains one or more tabs:

The criteria used to select data for the widget is specified in the Watch tab. For information on a widget’s Watch tab, see the discussion of the widget found later in this document.

The Fields tab is used to specify which fields of selected data to display in the widget. Here is the Fields tab for the Protocol widget:  file:///C:/Users/leya/Downloads/Personalization%20and%20Home%20Screen%20Configuration%20-%20OnCore%20Documentation.htm

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Use the checkboxes to specify which fields to display. Enter a value into a Maximum item display field to limit how many items are listed in the widget. (The number of items displayed in the Dashboard report will affect Home screen performance.) If there are more items than what is listed in this maximum field, they will not display in the widget. 

Note that there are two columns of checkboxes. The Dashboard column refers to the widget as shown on the Home screen. The

Expanded column refers to a pop up display that is launched by clicking the widget’s expand icon. 

 

Be sure to save your choices by clicking the Save button.

The Protocols, Subjects, and SAEs widgets can display bookmarked protocols and subjects. When configuring these widgets, one or more Bookmarks tabs are provided. The Bookmarks  Protocol  tab displays all the protocols you have bookmarked. The

Bookmarks  Subject  tab displays all the subjects you have bookmarked. 

Bookmarks tabs are used to remove bookmarks from protocols or subjects. Here is the Bookmarks  Protocol  tab for the Protocol widget: 

 

Selecting a Remove checkbox and clicking the Save button will remove the corresponding bookmark.

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Protocols Widget

Personalization and Home Screen Configuration - OnCore Documentation

The Protocols widget displays protocol data. Here is an example:

The fields that display for each protocol are configurable. The expand icon 

  displays an expanded set of protocol fields. (See the

Configuring Widgets section for more information on selecting the fields for the widget to display.)

The Protocol No. field is shown as a link. Clicking the link will display the protocol in the PC Console.

Protocol Selection – Configuring the Watch Tab

Widget configuration is done via the gear icon found at the upper right of the widget. Clicking the icon displays a pop up that contains a

Watch tab, which is used to select which of your protocols to display:

Display your bookmarked protocols by selecting Yes in the corresponding drop down list and clicking the Save button.

You may also display protocols where you are assigned as Protocol Staff. Three different selections must be made in the Display

Assigned Role area:

Select Yes in the drop down list.

Click the Please select a role link (or, if a role has already been selected, the Edit role(s) link) to display a pop up of Protocol Staff roles:  file:///C:/Users/leya/Downloads/Personalization%20and%20Home%20Screen%20Configuration%20-%20OnCore%20Documentation.htm

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Use the checkboxes to specify one or more of your Protocol Staff roles to use in protocol selection, then save your choices by clicking the Save button. The roles you have selected will display in the Watch tab.

If you wish to ‘filter’ the protocols where you are in a selected role, the checkboxes may be used to limit the widget display to protocols of a certain status:

Pending indicates protocols that are not yet Open To Accrual (New, On Hold, PRMC Approval, IRB Initial Approval, in

Signoffs).

Active indicates protocols that are Open To Accrual, Closed To Accrual, or Suspended.

Terminated indicates protocols with status Abandoned, Terminated, or IRB Study Closure.

If you do not use the ‘filtering’ checkboxes, all protocols where you are in one of the selected roles will be displayed.

After the three selections, be sure to click the Watch tab’s Save button.

Subjects Widget

The Subjects widget displays subject data. Here is an example: file:///C:/Users/leya/Downloads/Personalization%20and%20Home%20Screen%20Configuration%20-%20OnCore%20Documentation.htm

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The fields that display for each subject are configurable. The expand icon 

  displays an expanded set of subject fields. (See the

Configuring Widgets section for more information on selecting the fields for the widget to display.)

The Seq. No. field is shown as a link (subjects lacking a Sequence Number display a line in this column). Clicking the link will display the subject in the Subject Console.

Subject Selection – Configuring the Watch Tab

Widget configuration is done via the gear icon found at the upper right of the widget. Clicking the icon displays a pop up that contains a

Watch tab, which is used to select which of your subjects to display:

Display subjects from your bookmarked protocols by selecting Yes in the corresponding drop down list and clicking the Save button.

Display bookmarked subjects by selecting Yes in the corresponding drop down list and clicking the Save button.

You may also display subjects where you are assigned as Subject Staff. Three different selections must be made in the Display Assigned

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Select Yes in the drop down list.

Click the Please select a role link (or, if a role has already been selected, the Edit role(s) link) to display a pop up of Subject Staff roles: 

 

Use the checkboxes to specify one or more of your Subject Staff roles to use in subject selection, then save your choices by clicking the Save button. The roles you have selected will display in the Watch tab.

If you wish to ‘filter’ the subjects where you are in a selected role, these checkboxes may be used to limit the display to subjects of a certain status:

New indicates subjects with a New or Consented status.

Ineligible indicates subject with a Not Eligible status.

Eligible indicates subjects with an Eligible or Eligible(O) status.

Accrued indicates subjects that have been accrued to a study at some point (those with status Accrued, On Treatment, On

Follow Up, Expired, etc.)

If you do not use the ‘filtering’ checkboxes, all subjects where you are in one of the selected roles will be displayed.

After the three selections, be sure to click the Watch tab’s Save button.

SAEs Widget

The SAEs widget displays SAE data. Here is an example:

The fields that display for each SAE are configurable. The expand icon 

  displays an expanded set of SAE fields. (See the Configuring

Widgets section for more information on selecting the fields for the widget to display.) file:///C:/Users/leya/Downloads/Personalization%20and%20Home%20Screen%20Configuration%20-%20OnCore%20Documentation.htm

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The SAE No. field is shown as a link. Clicking the link will display the SAE in the SAE tab of the Subject Console.

SAE Selection – Configuring the Watch Tab

Widget configuration is done via the gear icon found at the upper right of the widget. Clicking the icon displays a pop up that contains a

Watch tab, which is used to select which of your SAEs to display:

Display your bookmarked protocol SAEs by selecting Yes in the corresponding drop down list and clicking the Save button.

Display your bookmarked subject SAEs by selecting Yes in the corresponding drop down list and clicking the Save button.

Registration Widget

The Registration widget displays subjects that are marked ‘Ready for Registration’ on the On Study tab of the Subject Console, and do not have an On Study date. Here is an example:

The fields that display for each registration are configurable. The expand icon 

  displays an expanded set of registration fields. (See the

Configuring Widgets section for more information on selecting the fields for the widget to display.)

The Name field is shown as a link. Clicking the link will display the subject in the Subject Console.

Configuring OnCore Registration

The Registration widget and Subject Console ‘Ready for Registration’ checkbox are only available if the

SHOW_READY_FOR_REGISTRATION OnCore configuration setting has been set to ‘True’. To modify an OnCore configuration setting, please contact OnCore support.

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The Reports widget lists reports based on your usage history. The most recently accessed report is listed first. Report names are links, and selecting one will display the report’s search criteria page:

Saved Searches Widget

The Saved Searches widget lists protocol and subject searches that you have saved. (See the Searches Overview for more information.)

Here is an example of a Saved Searches display:

Search names are links, and selecting one will display the Protocol Search or Subject Search page with preloaded search criteria.

Announcements Widget

When configured, the Announcements widget will automatically appear on every OnCore user’s Home screen. Only users with the appropriate privilege will be able to configure the Announcements widget. Please see the OnCore Administration Overview for more information on creating announcements.

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The OnCore Charge Master

OnCore provides a means to perform a variety of financial management tasks, including budgeting, invoicing, and payment reconciliation. The three main components of OnCore Financials are the Charge Master, Coverage Analysis

Console, and the Financials Console.

Exploring the Charge Master

The Charge Master defines events that may be associated with a budget for a study. Events include clinical labs and procedures, administrative tasks, and budgeting tasks. Each event definition contains a description, identifying codes, and charge information. The Charge Master can store different costs for each event, determined by the type of sponsor and the location where the procedures are performed.

The Charge Master groups events on the following tabs:

Protocol Related

This tab contains events that apply to a study, not to a particular subject on the study. Generally, protocol-related events such as IRB fees, advertising fees, and administrative charges are used for budgeting or invoicing purposes.

Subject Related

This tab contains events that are clinical events - labs, panels, and procedures. Each subject-related event is attributed to one subject on the study, and the number of subjects enrolled affects the number of subjectrelated events that are invoiced to the sponsor.

Budget Procedures

This tab contains events that are additional costs attributed to procedures and subject visits which are not directly captured by the clinical calendar

(schedule of events) but which are important in budgeting. One common example of a budget procedure is staff time or study coordinator fees during a

Charge Master | Page 1 of 23

subject visit, or a professional/technical fee required to perform or interpret a complex procedure. The budgeting team might include these costs for staff time/effort in the budget, in addition to the obvious cost of the procedure itself or any needed supplies.

Rate Bases and Cost Centers

The Charge Master stores both protocol-related events and subject-related events.

The costs for each event vary based on the type of study and the location where the event occurs.

Rate bases are different types of studies in the OnCore Charge Master. Each rate base represents a type of study or discount that might be applied to the retail (outof-pocket) cost for an event. The three example rate bases in Forte training/demo environments are the following:

IND (Industry-sponsored trials)

FED (Federal trials)

INV (Investigator-initiated trials)

An event or procedure can have different costs stored for each rate base. For example, if the retail cost of a Physical Exam is $375, you might give a greater discount to your own researchers for a local investigator-initiated study than you would to a pharmaceutical company who is sponsoring a nationwide clinical trial.

Consequently, the Physical Exam event in the Charge Master might have a $375 retail cost, a $325 IND rate base cost, and a $215 INV rate base cost to reflect those differences during budgeting.

In addition to rate bases, cost centers can also affect the cost of a Charge Master event. Cost centers are optional; if rate bases provide enough information to determine the cost of an event, cost centers do not have to be turned on in an

OnCore environment.

Cost centers provide more information about where a procedure was performed, the staff who were involved, or the supplies or equipment used during the procedure.

For example, the cost of an X-ray might be much higher if hospital staff were

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Charge Master | Page 2 of 23

required to perform and diagnose the X-ray than if the research team performed the

X-ray. As another example, the cost of a complete metabolic panel might be significantly less if it is sent to the Central Lab rather than resulted at a small or rural clinic.

Cost centers also determine which procedures appear on the billing slip for a subject visit. Cost centers are added to a reference code, each with a parent value such as Research or Hospital. Many organizations use cost centers in OnCore to identify the procedures performed by hospital staff (procedures performed at a cost center with a parent of hospital) and list only those procedures on the billing slip, for the hospital billing team to use for charge reconciliation.

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Protocol-related events in the Charge Master

Protocol-related events are fees for the overall protocol that do not change based on the number of subjects accrued. Some examples are IRB fees, pharmacy fees, advertising fees, and general start-up fees.

When you navigate to the Financials > Charge Master, the Charge Master opens on the Protocol Related tab. Note that the Charge Master is sorted into Protocol

Related and Subject Related events.

Each event has an Event Code, an Additional ID (optional), a Description (must be unique) and charges associated with one or more rate bases.

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Charge Master | Page 4 of 23

Create a protocol-related event

1.

Click Update.

2.

Create a new event by entering the following details in the Add Event section:

With Cost Centers No Cost Centers

Event Code: your initials-01

Event Description: your initials

Recruitment Fees

Click Add.

Click

Cost Centers next to the new protocol related event.

Choose a cost center and enter charges for each rate base:

Cost Center: 22354 – Clinical

Research Office

 Retail: 600

FED: 450

IND: 600

INV: 250

Click Add.

If this event might be performed at more than one cost center, choose another cost center from the drop-down list and enter charges for each rate base, then click Add.

When you are finished, click Close.

Event Code: your initials-01

Event Description: your initials

Recruitment Fees

Retail: 600

FED: 450

IND: 600

INV: 250

Click Add.

The new protocol event appears in the Protocol Related tab of the Charge

Master.

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Subject-related events in the Charge Master

Subject-related events are costs associated with a performed subject, visit, or procedure. Subject-related costs vary based on the number of subjects accrued or the number of visits that take place during a study.

Examples of subject-related events include the following:

Clinical procedures, such as a physical exam or biopsy

Labs and panels, such as a urinalysis or complete metabolic panel (CMP)

Budget-only procedures, such as staff time, specimen storage fees, or supplies (e.g., a surgical needle or tray) which are not represented on the clinical calendar

NOTE: The Subject Related tab is not clickable in the Charge Master; this tab groups the four tabs below it (Labs, Panels, Procedures, and Budget Procedures) which are all selectable.

Create a new lab event

1.

In the Charge Master, click Labs.

Like protocol-related events, each subject-related event has an Event Code, an

Additional ID (optional), an Event Description (must be unique) and charges for each rate base.

Labs and panels in the Charge Master are both collections of lab items (known as lab tests). For example, the Blood Chemistries lab event contains items such as Albumin, Calcium, and Cholesterol. Each item has an individual cost; the cost of a Lab Charge Master event is the sum of the cost of all selected items.

Panels are also collections of lab items, except that the items in a panel do not have individual costs. All items are resulted when a panel is ordered (panels are standard sets of lab tests, so they are typically cheaper), so the cost of the panel is always the same.

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Charge Master | Page 6 of 23

2.

Click Update (if you are in read-only mode), and then create a new lab event:

With Cost Centers No Cost Centers

Enter the following:

Event Code: your initials-02

Event Description: your initials

Electrolytes

Click Add.

Click Cost Centers next to the new lab event. Select the following:

Cost Center: 11204 - Laboratory

Click Add.

If this event might be performed at more than one cost center, choose another cost center from the drop-down list and click

Add.

When you have finished adding cost centers, click Close.

Enter the following:

Event Code: your initials-02

Event Description: your initials

Electrolytes

Click Add.

3.

Whether or not you are using cost centers, the process for adding lab items to the event is the same. Click Items next to the new lab event, and then add the following three items:

Item Code: 01

Item Description: Sodium

Click Add.

Item Code: 02

Item Description: Potassium

Click Add.

Item Code: 03

Item Description: Bicarbonate

Click Add.

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4.

Add costs for each lab item:

With Cost Centers No Cost Centers

Click Cost Centers next to each item.

Choose a cost center, enter charges for each rate base, then click Add.

Sodium:

 Retail: 25

FED: 18

IND: 24

INV: 12

Click Edit next to each item, enter charges for each rate base, then click Submit.

Sodium:

 Retail: 25

FED: 18

IND: 24

INV: 12

Potassium:

 Retail: 33

FED: 28

IND: 30

INV: 15

Potassium:

 Retail: 33

FED: 28

IND: 30

INV: 15

Bicarbonate:

 Retail: 14

FED: 12

IND: 14

INV: 6

Bicarbonate:

 Retail: 14

FED: 12

IND: 14

INV: 6

Create a new panel event

Charge Master Panel events are groups of lab items. The items must already exist in a Charge Master lab event in order to be added to a panel.

1.

In the Charge Master, click Panels. Click Update (if you are in read-only mode).

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Charge Master | Page 8 of 23

2.

Create a new panel event as follows:

With Cost Centers No Cost Centers

Enter the following: Enter the following:

Click Add.

Click Cost Centers next to the panel event.

Event Code: your initials-03

Event Description: your initials

Panel

Enter the following:

Cost Center: 11204 – Laboratory

Retail: 150

FED: 125

IND: 150

INV: 65

Click

Add.

If this event might be performed at more than one cost center, choose another cost center from the drop-down list, enter charges for each rate base, and then click

Add.

When you have finished adding cost centers, click Close.

Event Code: your initials-03

Event Description: your initials

Panel

Retail: 150

FED: 125

IND: 150

INV: 65

Click Add.

3.

Whether or not you are using cost centers, the process of adding items to the panel is the same. Click Items next to the panel event, and then click Items.

Use the Select? checkboxes to add items from any Charge Master Lab event to this panel. For example:

Bicarbonate

Potassium

Hematocrit

Charge Master | Page 9 of 23

4.

Click Submit to save your selections, and then click Close.

The new panel appears in the Panels tab of the Charge Master.

Labs and panels seem very similar… What’s the difference?

Both labs and panels in the Charge Master contain lab items, but they store charges differently. They also function differently during budgeting when they are linked to clinical procedures.

 Items in a lab have their own costs; items in a panel do not have individual costs.

 During budgeting, the total cost of a lab event is the sum of the charges for each item that is selected.

 During budgeting, the cost of a panel is always the same.

 When a lab is attached to a clinical procedure, items must be selected in order for the Retail and Research (IND/FED/INV) costs to calculate.

 When a panel is attached to a clinical procedure, all items are included automatically; no items can be selected or unselected.

Create a new procedure event

Clinical procedures on the calendar that are not considered labs or panels are built in the Charge Master as procedure events. In OnCore, the term procedures includes diverse Charge Master events such as:

 Biopsy

 Physical exam

 Ultrasound or scan

 Surgical procedure

 Injection

 Drug administration

 Wound treatment

…and many others

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Charge Master | Page 10 of 23

Procedures can have items, but they are not required. If a Charge Master procedure has items, the cost of the procedure is the sum of the charges for all items selected in the budget. If a Charge Master procedure does not have items, the cost of the procedure is set at the event level for the overall procedure.

1.

To create a new procedure event, navigate to the

Charge Master >

Procedures tab. Click Update, if necessary.

With Cost Centers No Cost Centers

Enter the following:

Event Code: your initials-04

Event Description: your initials

Wound Cleaning

Click Add.

Click Cost Centers next to the new procedure event. Choose any cost center.

Click

Add.

If this event might be performed at more than one cost center, choose another cost center from the drop-down list and click

Add.

When you have finished adding cost centers, click Close.

Enter the following:

Event Code: your initials-04

Event Description: your initials

Wound Cleaning

Click Add.

2.

Whether or not you are using cost centers, the process to add items to the procedure is the same: Click Items next to the new lab event. Enter the first item as follows, and then click Add.

Item Code: 01

Item Description: Gauze/supplies

Auto Add? select the checkbox

Charge Master | Page 11 of 23

3.

Repeat Step 2 to enter the second item, and then click Add.

Item Code: 02

Item Description: Wound care

Auto Add? select the checkbox

What does it mean to designate an item as Auto Add?

Items that are marked as Auto Add are automatically included when a Charge

Master event is linked to a clinical procedure during budgeting. In the previous step, selecting Auto Add? indicates that these items are always (or almost always) included when this Wound Cleaning procedure is ordered. Marking the items Auto Add saves you a few clicks when adding this event to a budget.

4.

Add costs to each item in the procedure event.

With Cost Centers No Cost Centers

Click Cost Centers next to each item in this procedure.

Choose a cost center, enter charges for each Rate Base, then click Add.

Gauze/supplies:

Retail: 40

FED: 30

IND: 37.50

INV: 12

Wound care:

Retail: 60

FED: 40

IND: 50

INV: 15

Click Edit next to each item, enter charges for each Rate Base, then click Save.

Gauze/supplies:

Retail: 40

FED: 30

IND: 37.50

INV: 12

Wound care:

Retail: 60

FED: 40

IND: 50

INV: 15

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Charge Master | Page 12 of 23

Consider adding budget procedures to the Charge Master

Budget procedures are costs that can be attributed to a particular subject visit that are not directly represented on the clinical calendar. These charges are important to include in the budget, but they do not affect the clinical schedule of events, and they do not need to be seen by the study team or patient on the subject calendar.

Budget procedures can cover a variety of hidden costs incurred during a subject visit, such as:

 Time spent by a PI, study coordinator, research nurse, physician, or technician

 Pharmaceutical dispensing or storage fees

 Specimen preparation, analysis, or storage fees

Packing/shipping supplies or fees such as dry ice or postage

 Administrative fees such as record filing or archiving

Although budget procedures do not display on the clinical calendar, they must be scheduled to the calendar on each visit when the charges are incurred. Budget procedures are scheduled the same way that free-text procedures and labs are scheduled: either to specific (enumerated) visits, or to certain days during cycle-based treatment segments.

Want to learn more?

To learn more about building calendars and scheduling procedures on visits, read the

Building Calendars section of the OnCore CRM Training

Manual or visit the

Specifications and Calendars page on the Learning Portal.

Budget procedures can occur multiple times on a subject visit. The budget procedures listed above can be built as one or more Charge Master events. As an example, you might create three Charge Master budget procedures: PI Time – 15 minutes, PI

Time – 30 minutes, and PI Time – 60 minutes. During startup, the financial and study teams can decide how much staff time to budget for during each visit, based on the quantity or complexity of procedures scheduled during that visit. Adding all three budget procedures to the calendar and scheduling one of them (the appropriate amount of time) to each visit is one way to account for these costs.

Charge Master | Page 13 of 23

Alternatively, you could build just one Charge Master budget procedure called PI

Time – 15 minutes and schedule it multiple times on each visit, to account for the estimated amount of staff time spent with the subject. Scheduling the 15-minute budget procedure to a visit and setting the No. of Occurrences to 4 will account for one hour of PI time. (4 x 15 minutes = 60 minutes)

Wait, didn’t I account for these costs by adding them as items to Charge

Master procedure events?

There are many ways to configure and use the OnCore Charge Master.

Technical/professional fees, storage and shipping fees, and administrative fees can be accounted for as items within a procedure, or as separate budget-only procedures.

What’s the advantage of building procedure items vs. budget procedures in the Charge Master to account for staff time, technical and professional fees, supplies, and other administrative charges?

Charge Master events linked to procedures on the clinical calendar are visible to staff when they check in a subject visit. If those Charge Master events have items, those items are also visible to staff (see screenshot on the next page).

During a Financials implementation project, Forte project managers and product support staff help you consider strategies for building and using the Charge Master based on your institution’s goals for using OnCore’s financial tools (sponsor invoicing, billing grid integration, etc).

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Charge Master | Page 14 of 23

Charge Master | Page 15 of 23

Create a new budget procedure

1.

In the Charge Master, click Budget Procedures. Click Update if you are in read-only mode (if there is no Add Event section at the top)

2.

Create a new event by entering the required information in the Add Event section.

With Cost Centers No Cost Centers

Enter the following:

Event Code: your initials-05

Event Description: your initials

Shipping w/Dry Ice

Click Add.

Click Cost Centers next to the new protocol related event. Choose a cost center and enter charges for each rate base:

Cost Center: 22354 – Clinical

Research Office

Retail: 38

FED: 38

IND: 38

INV: 38

Click Add.

If this event might be performed at more than one cost center, choose another cost center from the drop-down list and enter charges for each rate base, then click Add.

When you are done, click Close.

Enter the following:

Event Code: your initials-05

Event Description: your initials

Shipping w/Dry Ice

Retail: 38

FED: 38

IND: 38

INV: 38

Click Add.

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Charge Master | Page 16 of 23

The new budget event appears in the Budget Procedures tab of the Charge

Master.

Why are the charges for Shipping with Dry Ice identical for all Rate

Bases?

This is an example of an event that has a fixed cost that is the same for all studies, regardless of what type of sponsor or study it is. In this scenario, the cost to ship samples collected from a biopsy on dry ice is always the same; no discount is given to any sponsor or study.

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Versions of the Charge Master

The OnCore Charge Master can have one or several versions. The current version being viewed or edited in OnCore appears in the bottom-right corner of any tab in the Charge Master. Each version has an Effective Date of Release. Charge Master versions may be one of two states: Released or Unreleased. Charge Master versions must be Released in order to be used to create study budgets.

The Effective Date of the Charge Master

The Effective Date is when the Charge Master version takes effect. A version of the

Charge Master can have a past or future Effective Date; however, a version of the

Charge Master cannot be used during budgeting until after its Effective Date. The budgeting team might create a new version of the Charge Master in order to update costs that will take effect in the future; for example, updated pricing might take effect at the beginning of the next fiscal year.

The Effective Date can only be changed until the Charge Master version is released. The new Effective Date must be equal to or later than the previous

Effective Date.

IMPORTANT

Always confirm the Effective Date before releasing the Charge Master, because it cannot be changed after the Release Version button is pressed.

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Charge Master | Page 18 of 23

When a new version of the Charge Master is created, it is an exact copy of the current released version, minus any events that are retired. Release a version of the Charge Master by clicking the Release Version button.

IMPORTANT

Never release a new version of the Charge Master in a Forte training/demo environment.

Make changes to the Charge Master

Modifications to the Charge Master follow these rules:

 Changes to an event Description, Event Code, Additional ID, and Order are reflected in all versions of the Charge Master.

 Events can be created in any version of the Charge Master, but the

Description must be unique across all versions and all types of events.

 Events can be deleted if they’ve never been used on a budget.

 Events used on a budget cannot be deleted from the Charge Master; instead, they must be retired.

 Items can be added to labs, panels or procedures.

 Changes to costs/charges will not be reflected in previous versions of the

Charge Master. They will be reflected in the subsequent versions.

 Two separate privileges grant the ability to update the new (unreleased) version of the Charge Master and/or any released versions of the Charge

Master.

 You cannot have more than one unreleased version of the Charge Master.

Search for events in the Charge Master

Some Charge Masters have thousands of events and items. Use the Search feature in the Charge Master to find events or items:

1.

In the Charge Master, click the Search Events link.

Charge Master | Page 19 of 23

2.

Type blood in the Event/Item Description field, then click Search.

Any Charge Master event or item with “blood” in its description appears in the results.

3.

Click the Blood Chemistries event description to quickly open the lab event in the Charge Master.

Additional details stored in the Charge Master

The Additional Details tab of the Charge Master stores the following information:

 Default indirect rates for each rate base

 A list of cost centers are marked as TBD Cost

 A list of event groups

Several parameters are set when creating a new study budget in OnCore. One of these parameters is the Indirect Rate for the protocol. The indirect rate for a study can be entered for a protocol in the Financials Console, or the default in the Charge

Master can be used.

The Cost Centers tab allows you to indicate which (if any) of the cost centers allow events to have a TBD Cost in the Charge Master, which must be entered manually on each study budget during negotiations.

Event groups are collections of Charge Master events that are commonly used together. You can save time during budgeting by adding an event group instead of adding each event individually.

Export a version of the Charge Master

Large Charge Masters can be difficult to update and maintain. OnCore provides an import/export utility which can be used to make updates to any version of the

Charge Master.

1.

Navigate to Financials > Charge Master Export.

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Charge Master | Page 20 of 23

2.

Select a Charge Master Version to export, then click Submit.

The Charge Master will be exported to an Excel workbook with multiple tabs.

Each tab corresponds to a tab in the Charge Master: Protocol Related,

Procedures, Labs, Panels, and Budget Procedures.

The Charge Master Import utility requires an Excel spreadsheet in the exact same format as the spreadsheet generated by the Charge Master Export utility.

Start by exporting a version of your Charge Master, make changes to the spreadsheet, then import the updated Charge Master into any version of the

Charge Master.

New events can be added to the Charge Master with the import utility, but events cannot be deleted.

Update a Charge Master import/export spreadsheet

3.

Unhide the first column of the spreadsheet (column A) by highlighting

column

B, right-clicking on the column B header, and selecting Unhide.

Column A must contain the Update Type for any row in the spreadsheet that is changed. The Update Type should be N for New events or U for Updated events.

4.

Unhide column F by selecting columns E-G, right-clicking on the column

header, and selecting Unhide.

Column F contains the New Description for Event. All new events must have a unique event description. Changes made to existing events will only be made if the original Event Description remains exactly as-is in Column E; you can change an existing event’s description using the New Description for Event column (column F).

5.

Scroll to the bottom of the Protocol Related tab.

Charge Master | Page 21 of 23

6.

Add a new event by entering the appropriate event details in the first blank row of the spreadsheet:

Update Type: N

Event Code: your initials-990

New Description for Event: your initials Annual Audit Fee

Cost Center: 25800 **if you are using Cost Centers

Default Cost Center?: Y **if you are using Cost Centers

Retail: 600.00

FED: 500.00

IND: 575.00

INV: 125.00

7.

Save your updated Charge Master spreadsheet to your computer.

Import an updated Charge Master

1.

Navigate to Financials > Charge Master Import.

2.

Select the Charge Master Version to update.

3.

Click Choose File to browse to the saved spreadsheet on your computer.

OnCore reviews the submitted spreadsheet, then shows all warning and error messages in the Validate Data tab.

4.

When all errors and warnings are addressed (either fixed or accepted) click

Update Data to complete the import process.

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Charge Master | Page 22 of 23

Tips for importing the Charge Master

 The columns must exactly match the columns generated in the export file.

 The tabs in the workbook can be separated and imported individually – this reduces the number of warnings and errors that must be addressed at one time.

 Remove all rows in the spreadsheet for events and items that already exist and are not changing.

 Because panels contain items from lab events, the Panels tab must be uploaded separately, after the lab events and items have been added to

OnCore.

 If cost centers are enabled in OnCore, all charges must be associated with a cost center reference code. Each cost center that is applicable to an event must be in a separate row in the spreadsheet, with identical event details

(Event Code, Description, and so forth).

 Dollar amounts (entered for each rate base) must always be a number with exactly two decimal points.

 Do not import a Charge Master spreadsheet that contains formulas or formatting.

Charge Master | Page 23 of 23

Documenting Coverage Analysis in OnCore

When a new protocol is initiated, coverage analysis is performed to determine which procedures can be billed to the sponsor, what costs might be billable to the patient’s insurance provider, and if the study can be considered a Qualifying Clinical Trial according to Medicare regulations.

Procedures that can be submitted to Medicare or another insurance company require a modifier (Q1 or Q0) to indicate whether the procedure is a routine service or an

investigational clinical service related to the trial or the investigational device.

The Coverage Analysis Console in OnCore provides tools for:

 Documenting the logic/rationale used to determine whether the study is a

Qualifying Clinical Trial (QCT) according to Medicare rules

 Recording the billing designations selected for all procedures, to indicate how the costs will be covered for this trial

 Viewing the Billing Grid (a calendar view of all scheduled procedures and their respective billing designations)

Coverage Analysis | Page 1 of 16

Gathering Information for Coverage Analysis

Information from the protocol document, the schedule of events, the treatment arm(s), and other sources might be needed when performing coverage analysis. In the

Coverage Analysis console, a read-only view of the protocol details is available to coverage analysis team members (typically, they don’t have full access to see protocol information in the PC Console) as well as a link to all protocol attachments.

1.

Navigate to Financials > Coverage Analysis Console.

2.

Select a protocol from the

Select Protocol field.

The Coverage Analysis Console opens on the Protocol Summary > Details tab.

This tab provides read-only access to the information recorded in the PC Console >

Main tab.

Coverage analysis team members can review the basic protocol details, the protocol’s additional identifiers, the treatment details, the assigned staff, and the protocol sponsor(s). If the study is an investigational device (IDE) or an investigational drug (IND) protocol, those details are available for review, as well.

3.

Click Attachments.

Any protocol documents uploaded in the PC Console are available to view or download from the Protocol Attachment Details section of this page.

Additional documents related to the study’s coverage analysis can be uploaded to the

Coverage Analysis Attachment Details section of this page. Only OnCore users with access to the Coverage Analysis Console can see attachments uploaded here.

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Coverage Analysis | Page 2 of 16

Coverage Analysis | Page 3 of 16

Completing the QCT Checklist

The Qualifying Clinical Trial (QCT) checklist provides a place to record why a protocol does (or does not) qualify for Medicare reimbursement. You can document your rationale for device, non-device, and observational studies in the free-text fields; most coverage analysis teams record justifications and reference sources used to determine the protocol’s status. The questions on the QCT Checklist are not customizable, but they should reflect the standard questions considered during coverage analysis. The final decision can be recorded in the field labeled Is this a Qualifying Clinical Trial based

on Medicare guidelines?

1.

Navigate to the QCT Checklist tab.

2.

Click Update.

3.

Enter the details/rationale for QCT checklist questions, and then click Submit.

Does the study require items or services that are potentially billable to

a subject or third party payor? o

Yes

Which type of research is the study? o

Non-Device

If Non-Device, does the study have therapeutic intent as an objective? o

Yes

If Yes, what is the disease? o

“Subjects eligible for enrollment must have a diagnosis of cancerous tumor(s) in the liver, kidney, or abdominal cavity.”

Is this a Qualifying Clinical Trial based on Medicare guidelines? o

Yes

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Coverage Analysis | Page 4 of 16

Documenting Coverage in OnCore

Labs, panels, and procedures scheduled on the clinical calendar are listed in the

Procedures tab of the Coverage Analysis Console. During coverage analysis, billing designations are chosen for each procedure to indicate how the charges will be paid; items might be reimbursed by Medicare or by the patient’s insurance, or they might need to be negotiated with the protocol sponsor. Depending on how the clinical calendar is built, some procedures might not be billable at all, or their charges might already be included as part of the negotiated cost for a subject visit or milestone event.

Coverage Analysis | Page 5 of 16

Additional details are provided in the protocol document from the sponsor:

 The required Imaging procedure can be fulfilled by an MRI, CT scan, or ultrasound. By default, a CT scan should be performed, but sites will be reimbursed for MRI or ultrasound procedures which are deemed medically necessary by licensed research staff.

 The sponsor has agreed to cover the cost of the Physical Exam during the Off

Treatment segment if less than 12 months have elapsed since the Screening visit and the patient’s insurance will not cover the second exam.

 Subjects will be randomized to two arms (A and B). Subjects on Arm A of this study will receive the active ingredient being investigated plus a stabilizing agent which is thought to help increase absorption of the drug ($475 per administration). Subjects on Arm B will only receive the active ingredient ($90 per administration).

At your organization, it is standard practice to assess adverse events at every subject visit. The clinical procedure, data collection, and eCRF monitoring are not separately billable.

 For industry studies, it is appropriate to include the cost of staff time spent with the subject when negotiating with the sponsor.

 The follow-up phone calls (Y3-Y6) are not invoiceable to the sponsor individually; the sponsor has agreed to pay $850 for each subject who reaches a status of On Follow Up regardless of how long the subject remains in contact with their local study site.

Coverage Analysis | Page 7 of 16

Document coverage without linking to Charge Master events

1.

Navigate to the Coverage Analysis Console > Procedures tab.

2.

Click the Adverse Events Assessment procedure, and then click Update.

3.

Deselect the Bill to Sponsor? checkbox.

4.

Select Bundled Service, Not Separately Billable from the drop-down list attached to the Billing Designation field.

5.

Click Submit, and then click Close.

The Adverse Events Assessment procedure now has a billing designation of

NB.

6.

Click the Quality of Life procedure and then click Update, if necessary.

7.

Deselect the Bill to Sponsor? checkbox.

8.

Select Not Billable in the Billing Designation field.

9.

Click Submit, and then click Close.

The Quality of Life procedure now has a billing designation of NA.

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Coverage Analysis | Page 8 of 16

What are the billing designations in the Forte training/demo environments?

The chart below lists the billing designation codes and descriptions in Forte training environments:

F

Forms

S

Billable to Patient/Insurance

R

Paid for by Sponsor

NR Not Part of the Research Study

NA Bundled Service, Not Separately Billable

NB Not Billable

ICF Promised free in Informed Consent

Can we customize the billing designations in OnCore to match what we use at our organization?

The billing designations (codes and descriptions) are customizable via Admin >

Reference Codes. Be sure to work with OnCore product support or project management when making changes to this reference code; the description “Billable to Patient/Insurance” can change, but the meaning cannot change. This choice will map to a charge type of S (Standard of Care) in the Financials Console.

Similarly, the description “Paid for by sponsor” can be modified, but the intent cannot change; this code will map to a charge type of M (Milestone) in the

Financials Console.

Coverage Analysis | Page 9 of 16

All other billing designations can be modified as needed. Reference code values that are not “Billable to Patient/Insurance” or “Paid for by sponsor” will all map to a charge type of N/A in the Financials Console.

Bill to Sponsor

The event has been negotiated as part of the sponsor-paid budget.

Billable to Patient/Insurance

This event can be submitted to Medicare or another insurance company, based on Medicare Coverage Determination.

Bundled Service, Not Separately Billable

These services or items cannot be billed individually to the insurance provider but is included in the charge for a surgery or lab procedure.

Forms

This designation can be used with other billing designations to provide more details re: why the item or event is billable.

Not Billable

This event is not billable to insurance or to the sponsor. This procedure appears on the subject calendar. The organization wants to track this procedure, but the fees are absorbed internally. Not Billable is sometimes used in legacy studies to indicate an event which was not identified in the original budget or negotiations and now cannot be billed to the patient’s insurance or to the sponsor.

Not Part of the Research Study

This designation can be used with other billing designations to provide more details regarding why the item or event is billable. This event might not be specified by the protocol or it might not be a component of the research study.

No determination was made as to whether this is billable under normal billing rules.

Promised Free in the Informed Consent

This designation is primarily used in legacy studies where the sponsor budget is already finalized and the wording in the ICF indicates the event will not be charged to the subject or the subject’s insurance.

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Coverage Analysis | Page 10 of 16

Routine Costs

Routine costs is the standard term used to describe those events that would be performed on the patient, regardless of participation in a clinical trial. This is slightly different than the term OnCore uses for Standard of Care (SOC).

SOC is a more broad term and can be more subjective. Research documents are moving towards the term routine costs as defined by Medicare. **This is

not used as an actual billing designation.

Document coverage by linking to a Charge Master event

Billing designations can be selected before or after charge master events are linked to clinical procedures. If the billing designation is selected for the clinical procedure, it copies to any charge master events that are linked later. If the charge master event(s) are linked first, the billing designations must be set for each linked event separately.

IMPORTANT

Procedures can be linked to charge master events in the Coverage Analysis

Console or in the Financials Console. Billing designations can only be selected in the Coverage Analysis Console. Changes made to the charge types in the Financials Console affect the billing designations.

Each organization must decide which team or persons are responsible for each step of the workflow, and in what order the steps must be completed.

1.

Navigate to the Financials Console > Subject Related tab.

2.

Click the Physical Exam procedure.

3.

Before choosing a billing designation, click Add Events.

4.

Add the Charge Master event called Physical Exam, then click Submit.

Coverage Analysis | Page 11 of 16

Now that a Charge Master event is linked to this procedure, the billing designation cannot be set at the procedure level. The billing designation must be chosen for the charge master event, either for the whole event or for each visit individually.

Visit the OnCore Learning Portal at http://docs.onsemble.net

Coverage Analysis | Page 12 of 16

Choose different billing designations for different visits

1.

Click Visits in the Event Detail section.

The first physical exam (performed at the Screening visit) can be billed as a

SOC procedure to the patient’s insurance provider. The sponsor has agreed to pay for the second physical exam (performed after disease progression) since it will likely be less than 12 months since the first physical exam, and insurance providers typically only cover one physical exam per year.

2.

Deselect the Sponsor checkbox for the second physical exam, and then choose Billable to Patient/Insurance as the billing designation.

3.

Click Save.

The Charge Master event now displays Designations set at visit level. The billing designations for the physical exam must now be set using the Visits link.

4.

Now that the physical exam is set as a SOC procedure (for at least one visit) choose a Q1 Billing Modifier, then click Submit.

5.

Click

Close to return to the list of procedures.

Verify that the Physical Exam procedure has two billing designations listed: R and S (shows as R/S)

Clinical procedures can be linked to Charge Master events in the Coverage

Analysis Console or in the Financials Console. The coverage analysis team might be responsible for linking all clinical procedures to charge master events, even if the billing designation does not need to change from Bill to Sponsor.

Alternatively, the coverage analysis team might only be responsible for choosing billing designations, while the budgeting team does the linking and the cost tracking.

Finish the budget for this protocol in the Financials Console, using the Pre-Award

Budgeting section of this training manual.

Coverage Analysis | Page 13 of 16

Other Coverage Analysis Tools

View the billing grid

Once billing designations have been chosen in the Procedures tab, the designations appear in the Billing Grid for every procedure/event scheduled on each calendar visit.

1.

Navigate to the Coverage Analysis Console > Billing Grid tab.

The default view shows the billing designations selected at the procedure level.

If the study has multiple arms, each arm has its own section in the Billing Grid.

Click the + expand icon next to any clinical procedure to see the designations selected for the Charge Master event(s) linked to it.

2.

Choose Billing Grid Display Filters, and then click Refresh.

 Example: select Protocol

Arm A.

 Example: select Paid for by Sponsor in the Billing Designation Filter.

With this filter applied, the Billing Grid displays only procedures on visits for which the sponsor has agreed to pay.

Visit the OnCore Learning Portal at http://docs.onsemble.net

Coverage Analysis | Page 14 of 16

With only one treatment arm selected, the Freeze Panes option is available when reviewing the Billing Grid. Freeze Panes allows you to keep the procedures in view as you scroll through the schedule of events.

Coverage Analysis | Page 15 of 16

Adding coverage documents/attachments

Supporting documentation, reference documents, and other attachments can be uploaded to the Coverage Analysis Console > Attachments tab.

Protocol documents uploaded in the PC Console can also be viewed on this tab.

Any documents uploaded to the Coverage Analysis Console can be viewed only in this console; only users with access to the Coverage Analysis Console can see these attachments.

Visit the OnCore Learning Portal at http://docs.onsemble.net

Coverage Analysis | Page 16 of 16

Financial Budgeting in OnCore

Many organizations use OnCore to track sponsor negotiations and compare budgeted costs to actual costs of a research study. Setting up a protocol budget includes many “pre-award” tasks that are typically completed before subject enrollment and visit tracking begins. Pre-award tasks related to budgeting and invoicing include:

 Setting indirect and/or overhead rates

 Choosing a “rate base” for a protocol sponsor

 Billing for SAEs, OSRs, and screen failures

 Adding bill-to and remit-to addresses for invoicing

 Entering negotiated costs for subject procedures and labs

 Tracking protocol-related costs (startup fees, IRB review fees, etc)

 Choosing billable milestones

Financial Budgeting | Page 1 of 37

Before Building a Budget in OnCore

A protocol must have a principal sponsor and a clinical calendar before the study budget is created. Some of the financial-related parameters for a protocol are specific to one sponsor, and can vary if multiple sponsors are involved with the study. Costs are calculated for visits on the clinical calendar based on the procedures and labs scheduled for each visit.

List all sponsors and indicate the principal sponsor

Sponsors for a protocol are listed in the PC

Console > Main > Sponsor tab. More than one sponsor can be associated with a study.

Regardless of the number of sponsors listed in the

PC Console, one must be flagged as the principal sponsor before the protocol’s financial parameters can be set in the Financials Console.

Want to learn more?

To learn more about managing protocols in OnCore, visit the

Protocols page on the Learning

Portal.

If a principal sponsor has been selected for a protocol, the sponsor will be listed in the header of the PC Console or the Financials Console:

Financial Budgeting | Page 2 of 37

Build a clinical calendar

Once a clinical calendar is built in OnCore (with visits and scheduled procedures) the budget is created by entering negotiated costs for procedures, subject milestones, and other research-related costs.

Complex calendars with numerous labs and procedures or multiple treatment arms can have a very precise budget in OnCore, but even a simple calendar with one generic procedure and a handful of visits allows an organization’s financials team to enter negotiated costs in the budget, track subject visits, and invoice the sponsor.

Learn more about building clinical calendars by visiting the Specifications page on the Learning Portal.

Build your Charge Master

If you plan to use a Charge Master to store standard costs for study budget events, the

Charge Master should be built or uploaded into OnCore before creating any protocol budgets.

Most organizations only upload a subset of events from their hospital’s comprehensive

Charge Master into OnCore for research budgeting. During a financials implementation

Want to learn more?

Learn more about uploading and managing Charge Master events in OnCore in section 1 of this manual, or by visiting the

Charge Master page of the

Learning Portal. project, Forte project managers provide guidance and best practices from other

OnCore customers that use a Charge Master for budgeting.

Financial Budgeting | Page 3 of 37

Setting up Study Parameters

The first step in creating a study budget is to set parameters in the Financials

Console which affect the protocol’s budget reports and sponsor invoices.

Parameters used by OnCore’s financial tools include:

 Rate base(s)

 Sponsor withholding %

 Overhead and indirect rates

 Billing and remitting contact information

 Invoicing details for SAEs, OSRs, and screen failures

The most common financials workflow in OnCore involves “pre-award” tasks related to budgeting, and “post-award” tasks related to invoicing. The Parameters tab of the

Financials Console is divided into two sections: budget-related parameters used during the “pre-award” workflow, and invoice-related parameters used in the “postaward” workflow.

Set budget related parameters

Budget-related parameters affect how OnCore’s financial reports calculate the actual costs of a research study and determine if indirect costs are calculated on invoices.

1.

Navigate to Financials > Financials Console.

2.

Use the Select Protocol field to open a protocol with at least one sponsor and a clinical calendar with visits and scheduled procedures.

Verify that a sponsor is listed in the header of the Financials Console. The sponsor in the header is flagged as the “principal sponsor” for this protocol.

3.

Click Update.

Financial Budgeting | Page 4 of 37

4.

Choose a default Rate Base for this protocol. For example:

Rate Base: IND – Industry

5.

Choose a Default Sponsor for this protocol.

If this protocol only has one sponsor, it will be selected by default.

6.

Enter the Withholding percentage for the sponsor(s). For example:

Withholding: 10%

7.

Select checkboxes to indicate which type(s) of billable items qualify for withholding.

 Select Protocol-Related events and Subject Milestones

Do not select Pass Thru Items.

8.

Leave the Inflation Multiplier at 1.0.

Inflation can be calculated for long-term studies that will be active for many years.

9.

Enter an Overhead Rate and/or Indirect Rate.

Overhead and indirect costs can be added to negotiated costs in OnCore’s budget reports and sponsor invoices. Overhead and indirect rates are similar, except that the indirect rate can be applied to subject-related charges, protocolrelated charges, milestones, or any combination of those charge types.

Overhead Rate: leave blank

Indirect Rate: 25%.

Financial Budgeting | Page 5 of 37

10.

In the Settings for Application of Indirect Charges section, select checkboxes to indicate that indirect charges apply to subject events but not milestones or protocol events.

NOTE: These parameters for applying indirect costs are simply the default settings for this protocol; indirect can be applied or removed from any subjectrelated event or protocol-related event during budgeting, if needed.

11.

Leave the

Apply indirect charges during

budgeting only? checkbox unselected.

For this protocol, the sponsor has agreed to pay an additional 25% for subject charges and milestones. Leaving this checkbox unselected will show the indirect costs calculated in the budget reports and on the sponsor invoices.

Want to learn more?

Click the question mark (?) in the top-right corner of the

Parameters tab to learn more about all budget-related settings.

12.

Leave the View Budget Display Options? checkbox selected for the most flexibility when generating budget reports.

Financial Budgeting | Page 6 of 37

Set invoice related parameters

Invoice-related parameters determine whether and when the sponsor can be billed for SAEs, OSRs, ineligible subjects, and subject visits. If it would be valuable, an email reminder can be configured in the Parameters tab to remind the appropriate person or team to complete invoicing for this protocol.

1.

Enter a Screening Failures Invoice Ratio of 1:3 to indicate that one screen failure can be invoiced after 3 subjects have successfully enrolled on this study.

2.

Choose the Enrollment Status at which a subject qualifies as “enrolled” on this study.

Enrollment Status: ON STUDY

3.

For Initial Invoiceable Screening Failures, type 5.

This indicates that the sponsor can be billed for the first five ineligible subjects, regardless of how many eligible subjects have been registered.

4.

For Maximum Screening Failures, type 50 (which is appropriate if the accrual target for this study is 150 enrolled subjects).

5.

Enter values for No. of SAEs/OSRs After Which Sponsor Will Be Invoiced.

 Example: If the sponsor has agreed to pay $75 for each SAE after the

first 5, enter a value of

6. The 6 th

SAE that occurs will be invoiceable, as well as all SAEs recorded after that.

 The OSRs field works in the same way. Entering a value of 5 would make the 6 th

OSR billable.

6.

Enter a value for Maximum Invoiceable OSRs for this study.

 Example: The sponsor has agreed to pay for all OSRs beyond the first 5, so enter a large maximum value such as 999.

Financial Budgeting | Page 7 of 37

7.

Choose a visit status in the Milestone Invoiceable Visit Prerequisite field, to indicate when occurred visits are available for invoicing.

 Example: Visits for this study can be invoiced as soon as they have

occurred.

8.

Configure an Invoicing Reminder to be sent every 2 months, starting two months from today. Be sure to send one follow-up notification after study closure.

Want to learn more?

Notification Frequency: 2

Number of invoice reminders to

send after study closure: 1

Notification Start Date: m+2

NOTE: The Invoice Reminder notification must be configured to send to the appropriate staff member(s) or email address(es), either at the protocol level or at the Library level.

Learn more about configuring notifications (including the

Invoice Reminder Notice) on the

Notification Administration page of the Learning Portal.

For other Parameters tab questions, click the ? icon in the upper right of the page.

9.

Add a Remit To address for invoicing. Then click Add.

Organization Name: Outstanding Research Center

Contact: Jim Henson

Address: 1445 Keystone Way, Winchester NV 88902

10.

Add at least one Bill To address for invoicing. Then click Add.

Organization Name: Amgen

Contact: Mary Lou Stevenson

Address: 308 S Main, Allegan MI 49010

Email: [email protected]

Additional Bill To addresses can be added if more than one sponsor will receive invoices for this protocol.

11.

Click Submit to save all changes in the Parameters tab.

Financial Budgeting | Page 8 of 37

Budgeting for Protocol-Related Costs

A comprehensive protocol budget typically includes charges that cannot be attributed to one particular subject, such as IRB review fees and pharmacy fees.

These costs do not change based on the number of subjects enrolled on the protocol; IRB review fees and startup fees must be paid, regardless of how many subjects join the research study. Some protocol-related costs must be paid annually or quarterly, while others are only paid once at the start of the trial.

These types of study costs are built in the Charge Master as protocol related events, and can be included in a protocol budget by adding them to the Protocol

Related tab of the Financials Console. Protocol related costs are included in the

Budget Summary and Budget Calendar reports in order to accurately determine the actual cost of an OnCore protocol.

Add protocol-related costs to a budget

1.

Navigate to the

Financials Console > Protocol Related tab.

2.

To include protocol-related events from the Charge Master in this budget, click

Select. (If you do not see a Select button, click Update first.)

3.

In the pop-up window, search for the following protocol-related events in the

Charge Master, and then click

Add:

IRB Initial Review

IRB Annual Renewal

Quarterly Pharmacy Fee

4.

Enter the Negotiated cost that the sponsor has agreed to pay for each of these study fees.

Example: The sponsor has agreed to pay $4000 for the initial IRB review and $2000 for each annual renewal after that.

Financial Budgeting | Page 9 of 37

 The sponsor has agreed to reimburse the quarterly $350 fee for pharmacy staff and storage costs.

5.

Mark any events that can be billed more than once as Variable.

 Example: You only submit this protocol for initial IRB review once, at the beginning of the study. But you must resubmit the protocol each year for re-review, and you must pay the pharmacy fees every 3 months while the study remains open. Therefore, select the Variable checkboxes for the Quarterly Pharmacy Fee and the IRB Annual Renewal.

Configure protocol charges to be triggered automatically

IRB fees can only be invoiced once per year, after the IRB review has occurred and been documented in OnCore. To prevent accidental double-billing the sponsor, configure a trigger to hide the IRB Annual Renewal event until a continuing IRB review has been recorded for this protocol. The IRB Annual Renewal fee can only be billed once the review is documented in the PC Console, and it can’t be added again until another continuing review occurs.

1.

Click the IRB Annual Review link.

2.

In the Event Triggers section, click

Add.

3.

Select an IRB Review with a reason of Continuing Review (either Full or

Expedited) as the trigger for this event, then click Save.

To select both the Expedited and Full review types, you would hold CTRL and click each type.

4.

Click Submit and then Close.

Note: In the Parameters tab, indirect costs were not applied to protocol-related events by default. If any of these protocol costs should have a 25% indirect cost included in the budget reports and invoices, you could select the Indirect? checkbox for that event.

Financial Budgeting | Page 10 of 37

Budgeting for Subject-Related Costs

Unlike protocol-related costs, subject-related costs can be directly attributed to a particular subject enrolled on the study, and the actual charges will vary based on the number of subjects who participate on the trial. Some subject-related charges need to be adjusted when certain procedures or visits are missed, or when additional unplanned procedures were necessary for a subject. Most of the subjectrelated costs in a budget are associated with the clinical procedures performed at each visit; the clinical calendar (scheduled visits and procedures) is the framework for budgeting for subject related costs.

In addition to the baseline costs for each lab and procedure scheduled on the subject calendar, it is important to account for extra “hidden” costs incurred during subject visits; consider staff costs, any equipment used, technical and professional fees, or lab prep/readings.

Financial Budgeting | Page 11 of 37

Additional details provided in the protocol document from the sponsor:

 The required “Imaging” procedure can be fulfilled by an MRI, CT scan, or ultrasound. By default, a CT scan should be performed, but sites will be reimbursed for MRI or ultrasound procedures which are deemed medically necessary by licensed research staff.

 The sponsor has agreed to cover the cost of the Physical Exam during the Off

Treatment segment if less than 12 months have elapsed since the Screening visit and the patient’s insurance will not cover the second exam.

 Subjects will be randomized to two arms (A and B) – subjects on Arm A of this study will receive the active ingredient being investigated plus a stabilizing agent which is thought to help increase absorption of the drug ($475 per administration).

Subjects on Arm B will only receive the active ingredient ($90 per administration).

At your organization, it is standard practice to assess adverse events at every subject visit. The clinical procedure, data collection, and eCRF monitoring are not separately billable.

 For industry studies, it is appropriate to include the cost of staff time spent with the subject when negotiating with the sponsor.

 The follow-up phone calls (Y3-Y6) are not invoiceable to the sponsor individually

– the sponsor has agreed to pay $850 for each subject who reaches a status of

On Follow Up regardless of how long the subject remains in contact with their local study site.

View the Subject Related tab

1.

Click the Subject Related tab of the Financials Console.

The events in the Subject Related tab are the free-text procedures, labs, and panels on this protocol’s clinical calendar. Budget for these subject-related charges by manually entering costs for each event, or by linking each procedure/lab to a Charge Master event with standard costs.

Financial Budgeting | Page 13 of 37

Billing designations translate to exactly four charge types

Notice that the procedures in the Subject Related tab have one of four charge types:

S (Standard of Care)

These charges are not billable to the sponsor. Costs marked as Standard of Care are assumed to be reimbursed by Medicare or by the subject’s insurance. If applicable, a Q1 or Q0 modifier can selected for Standard of Care procedures.

M (Milestone)

These charges are billable to the sponsor. They are included in the total calculated cost for visits selected as invoiceable milestones.

P (Pass Thru)

These charges are billable to the sponsor. When a procedure marked Pass Thru occurs on a subject visit, the charge appears as its own invoiceable item in the

Financials Console. When added to an invoice, each Pass Thru procedure is listed as its own line-item. Pass Thru charges are not included in the total calculated cost for billable milestones.

N/A (blank; not applicable)

These costs are not billable to the sponsor. These charges are not included in the calculated milestone costs, and they cannot be put on an invoice.

These charge types correspond to Coverage Analysis billing designations as follows:

When “Billable to Patient/Insurance” is selected as the billing designation in the

Coverage Analysis Console, the procedure is assigned a charge type of S (Standard of

Care) in the Financials Console.

When “Bill to Sponsor” is selected as the billing designation in the Coverage Analysis

Console, the procedure is assigned a charge type of M (Milestone) in the Financials

Console. The charge type can be changed to P (Pass Thru) without affecting the billing designation. Procedures are never assigned a charge type of P by default; events must be manually designated as Pass Thru when appropriate.

Financial Budgeting | Page 14 of 37

When any other billing designation is selected in the Coverage Analysis Console, the procedure is assigned a charge type of N/A. The Charge Type column in the Subject

Related tab will be empty for that procedure unless a Charge Master event is linked to the free-text procedure, in which case an N is listed.

IMPORTANT

Any changes made to a procedure’s charge type in the Financials Console can affect the billing designation selected in the Coverage Analysis Console! The financials team and the coverage analysis team must work together to determine a standard operating procedure (SOP) for performing coverage analysis and budgeting for a protocol. Signoffs can be used to ensure that each team has the opportunity for final review of the entire budget before it is released.

the billing designation – both charge types correspond with the default “bill to sponsor” billing designation in the Coverage Analysis Console.

Budget for clinical procedures without a charge master

The Adverse Events Assessment and Quality of Life procedures both have a charge type of N/A in the Financials Console, even though different billing designations were selected while performing coverage analysis.

The Physical Exam procedure has two charge types listed (S/M) because billing designations were chosen at the visit level; the physical exam at Screening was marked as Standard of Care, but the physical exam after treatment will be billed to the sponsor, so it has a charge type of Milestone.

Standard retail and research costs for the Physical Exam procedure are listed here because the free-text procedure was linked to a Charge Master event during coverage analysis. However, negotiated costs for procedures can be entered manually without linking to a Charge Master event:

1.

Click the Adverse Events Assessment procedure.

While reviewing the coverage analysis for this study, you decide that the budget should account for staff time required to discuss and update a subject’s list of

Financial Budgeting | Page 15 of 37

adverse events at each visit, and that these costs should be negotiated with the sponsor.

2.

Change the Charge Type from N/A to M (for Milestone) by selecting the appropriate radio button.

NOTE: Remember that this action changed the billing designation back to “bill to sponsor” in the Coverage Analysis Console. Be sure to communicate this change to your coverage analysis team.

3.

Enter a Negotiated Cost of $25.00 for this procedure, and then click Submit.

Now, when milestone (visit) costs are calculated, each occurrence of the Adverse

Event Assessment procedure will add $25 to the total milestone cost.

Budget for clinical procedures using a charge master

Even within the same study budget, some procedures might be budgeted using the

Charge Master, and others might be budgeted without it. It is common (but not required) to use the Charge Master to compare negotiated costs to standard costs when building a budget.

1.

Choose the Complete Metabolic Panel in the Switch Procedure field at the bottom of the Procedure Details page. (Alternatively, from the Financials Console >

Subject Related tab, click the Complete Metabolic Panel link.)

2.

Click Add Events.

3.

Search for Complete Metabolic Panel to find the Charge Master panel event.

4.

Click Add, then click Submit.

The Charge Master panel event is now linked to the clinical panel on the calendar.

Financial Budgeting | Page 16 of 37

The Retail cost and the Research cost are brought in from the Charge Master event.

The Research cost is the charge for this panel according to the Rate Base selected on the Parameters tab.

By default, the Negotiated cost is the Research cost for this charge master event.

The Indirect? checkbox is selected (or unselected) based on the default indirect settings for this study in the Parameters tab.

The Charge Type selected corresponds to the billing designation selected in the Coverage

Analysis Console.

Want to learn more?

The default Charge Type can be M

(Milestone) or N/A. The system-wide default is determined by the

DEFAULT_CHARGE_TYPE configuration setting.

Learn more about all financialsrelated system settings on the

Configuration Options page of the

Learning Portal.

Financial Budgeting | Page 17 of 37

What are Cost Centers, and why might I use them?

Cost Centers are typically locations where procedures might occur during a research study. Cost Centers are either enabled or disabled in an OnCore environment. When enabled, Cost Centers provide additional details about where a procedure was performed if the location affects the price of the procedure.

Good to know

Cost Centers are enabled in

Forte training and demo environments. Learn more about Cost Centers in the

Charge Master section of this training manual, or on the

Charge Master page of the

Learning Portal.

For example, a complete metabolic panel might cost $90 when performed at the hospital and sent to the central lab for processing, or $150 when performed by staff at the local clinic and processed by the local lab.

Cost Centers can also be used during subject visit tracking, to determine which procedures were performed at the hospital and should be listed on the Billing Slip, and which procedures were performed by research staff and will not incur any charges for the hospital.

Financial Budgeting | Page 18 of 37

Include multiple items when budgeting with a charge master

1.

Choose the Tumor Biopsy in the Switch

Procedure field at the bottom of the

Procedure Details page. (Alternatively,

Good to know

2.

3.

4.

click the Tumor Biopsy link from the

Financials Console > Subject Related tab.)

Click Add Events.

Search for the event.

Click

Biopsy charge master

Add, then click Submit.

Any charge master event(s) can be linked to clinical procedures on the calendar, even if the

names and descriptions don’t

match.

Clinical procedures typically have patient-friendly descriptions or labels that match the sponsor calendar exactly, while charge master events typically have more detailed codes and descriptions used by the financial team.

In this case, the research cost did not default in as the negotiated rate for this event. That’s because the Biopsy charge master event has several items, each with its own cost. The cost of the Biopsy event is the sum of the costs of all included items.

Two items (the Technical Fee and the needle) were included by default because they were designated as Auto Add items in the Charge Master. Include additional items in this budget to recalculate the retail and research costs of this event.

5.

Click the Items link.

Note that the Auto Add items are automatically included in this budget.

Financial Budgeting | Page 19 of 37

6.

Select the checkbox(es) to include additional items in this budget.

 Select the

Prep and reading of tissue, the Biopsy procedure, and the tray

items

7.

Click Submit.

The Retail and Research rates have recalculated to include the costs of the additional items.

8.

The sponsor has agreed to cover all costs associated with the biopsies performed during this study. Enter the total Research cost in the Negotiated cost field, and then click Submit.

Charge master procedures (such as the Biopsy event) can have items, but procedures are not required to have items. Charge master labs always have items, and the cost of the lab event is always determined by the items included in a study budget.

9.

Choose Blood Chemistries in the Switch Procedure field at the bottom of the

Procedure Details page (or click the Blood Chemistries link from the Financials

Console > Subject Related tab).

10.

Click Add Events.

11.

Search for the Blood Chemistries charge master lab event.

12.

Click Add, and then click Submit.

No items are selected by default when a charge master lab is linked to a clinical calendar.

Financial Budgeting | Page 20 of 37

13.

Click Items. Select the appropriate checkbox(es) to include the following lab items in this protocol budget:

Amylase

Cholesterol

Sodium

Uric Acid

14.

Click Submit.

15.

Enter the total Research cost for the Blood Chemistries event in the Negotiated field, and then click Submit.

Financial Budgeting | Page 21 of 37

Set visit-specific costs for a procedure

Subjects on Arm A of this study will receive the active ingredient being investigated plus a stabilizing agent which is thought to help increase absorption of the drug. Subjects on

Arm B will only receive the active ingredient. The cost of the Treatment Administration procedure will vary based on the subject’s assigned treatment arm. Use OnCore’s

Financials Console to set visit-specific costs for the Treatment Administration procedure:

1.

Select

Treatment Administration in the Switch Procedure field at the bottom of the Procedure Details page (or click the Treatment Administration link from the

Financials Console > Subject Related tab).

2.

Click Add Events.

3.

Search for

Treatment Administration in the charge master (you might find an event called Treatment and Drug Administration)

4.

Click Add, and then click Submit.

The Treatment Administration event does not have a Retail or Research charge because it is marked as TBD Cost in the charge master; the cost of drugs and treatments varies widely across an organization’s research portfolio. The charges for a protocol’s trial drug must be entered manually in the study budget.

5.

Enter a Negotiated charge of $475, and then click Submit.

Save time by entering a Negotiated charge at the event level; then, you will only need to modify the charges for visits where the cost is different.

6.

Click the Visits link.

Financial Budgeting | Page 22 of 37

7.

Change the cost to $90 for all Arm B visits, then click Save.

A checkmark next to the Visits link indicates that visit-specific settings (either costs, charge types, or both) have been entered for this event. You can no longer change the charge type or the negotiated cost for this event with one click; make changes at the visit level, or click Clear to remove all visit-specific settings.

Provide multiple alternatives for a clinical procedure

Some clinical procedures on the calendar can be achieved in more than one way during a subject visit; the research staff might decide to perform an MRI, a CT Scan, or an

Ultrasound for a subject, depending on the resources available at the subject’s location or the subject’s physical limitations. These procedure alternatives might be medically necessary for certain subjects, but the cost can vary greatly depending on the procedure that is actually performed. When it is not possible to determine exactly which what procedure will be performed at each visit, the clinical staff can choose from a list of

procedure alternatives when the visit occurs.

1.

Select Imaging in the Switch Procedure field at the bottom of the Procedure

Details page (or click the Imaging link in the Financials Console > Subject Related tab)

2.

Click Add Events.

3.

Find all possible charge master events that might be performed when a subject visit occurs and link them to the Imaging procedure.

 Search for CT Scan and click Add.

 Search for MRI and click Add.

 Search for Ultrasound and click Add.

4.

If any of the linked charge master events have items, click Items and select the appropriate checkboxes to include items in the budget for the Imaging procedure.

5.

Enter the Negotiated Cost for each charge master event, and then click Submit.

Financial Budgeting | Page 23 of 37

When multiple events are linked to a clinical procedure in the budget, OnCore assumes that all events should be included in the budget.

6.

Select the Procedure Alternatives? checkbox to indicate that only one of the linked events will be performed at each visit.

IMPORTANT

If you select the Procedure Alternatives? checkbox, only one of the linked events can be selected (and invoiced for) when a visit occurs.

7.

Click Submit.

The research staff can select the event that was performed when the visit is marked as Occurred on the subject calendar.

8.

The Negotiated cost field for the clinical procedure is now editable at the top of the

Procedure Details window. Enter the value that OnCore should use when budgeting for this procedure.

 For subjects on this study, a CT scan is typically done when imaging is required at a visit. An MRI is occasionally performed when more detailed images are required for analysis. Enter an estimated Negotiated Cost of

$1200 for the overall clinical procedure.

This is the value that will be used to calculate the actual cost of each subject visit/milestone for this protocol. The negotiated cost for the overall procedure will be used in the Budget Summary and Budget Calendar reports.

Financial Budgeting | Page 24 of 37

Select pass thru procedures

Most charges that are billable to the study sponsor are invoiced as part of a subject visit milestone. Some procedures (typically “big-ticket” items like MRIs and CT scans) must be invoiced separately. An event marked as Pass Thru has additional features in

OnCore:

 Appears as its own line item when added to a sponsor invoice

 Can be invoiced to the sponsor immediately when it is performed—even if the milestone cost of the corresponding subject visit can’t be invoiced for several weeks—after the data is monitored or locked.

 Its indirect rate can be configured independently from subject milestones

 Its charge can be edited directly on an invoice if needed (milestone costs cannot be modified)

 When procedure alternatives are marked as Pass Thru, the sponsor can be invoiced for the actual (negotiated) cost each time an event occurs.

1.

Select the Pass Thru radio button for the MRI, CT Scan, and Ultrasound charge master events.

2.

Click

Submit, and then click Close to return to the Subject Related tab of the

Financials Console.

Financial Budgeting | Page 25 of 37

Include “budget only” costs incurred during subject visits

When the financials team wants to budget for additional visit charges that cannot be directly attributed to procedures on the clinical calendar, budget procedures can be added to the list of known subject-related costs. Budget procedures can be scheduled to clinical visits but will not be seen by the research staff or the patient – budget procedures are included on the financial calendar and billing grid, but not on the subject calendar.

Budget procedures are built in the Charge Master and then added to a protocol budget in the Subject Related tab of the Financials Console.

Beyond the costs of clinical procedures performed, additional costs can be included in the budget as indirect or overhead costs, protocol-related charges, or budget procedures. Organizations employ a variety of budgeting strategies to define and account for these additional costs. Examples of budget procedures might include:

 Coordinator time, PI time, research nurse time, or time spent by other staff

 Dry ice, shipping, or storage costs for lab samples or specimens

 Pharmacy fees (if charged per subject or per drug administration)

1.

On the Financials Console > Subject Related tab, click Budget Procedures.

2.

In the pop-up window, search for the event called Research Nurse – 30 min.

3.

Click Add, and then click Submit.

The budget procedure is added to the list of procedures on the Subject Related tab. It appears at the bottom of the list and is indicated by an asterisk.

Budget procedures must be scheduled to calendar visit(s) on which they are incurred. Just like clinical procedures, budget procedures can be scheduled multiple times on one visit if needed.

Financial Budgeting | Page 26 of 37

4.

Click the Research Nurse – 30 min budget procedure.

By default, the Negotiated cost field is populated with the Research cost for this event. But this budget event is currently not scheduled for any calendar visits, so it will not be included in the budget; no charge will be listed in the Budget Summary or Budget Calendar reports.

5.

To schedule this budget procedure on calendar visits, click the Visits/Schedules link at the bottom of the Procedure Details page. (Do not click the Visits link in the

Event Detail section.)

6.

You will schedule the Research Nurse budget event on all visits that require faceto-face interaction between the research staff and the subject. On the Visits tab, select the following enumerated visits, and then click Submit.

Screening visit

 Both Off Treatment visits

In-clinic follow-up visits

7.

On the

Treatment Schedules tab, select the following cycling visits, and then click

Submit.

Treatment segment Day 1 visits

Treatment segment Day 15 visits

Maintenance segment Day 1 visits

8.

Click Close.

9.

Click the Details button to schedule this budget procedure more than once on any calendar visit.

During the screening visit, a member of the protocol team usually spends about an hour with each subject, going over the informed consent and protocol details. Enter

2 for the Screening visit to account for two 30-minute blocks of staff time.

10.

Click Submit, and then click Close.

The budget now includes the cost for the staff who perform the clinical visits.

Financial Budgeting | Page 27 of 37

OnCore Financial Reports

Two standard budget reports are available in

OnCore and are frequently used to analyze the actual vs. negotiated costs of a study budget.

The Budget Summary report calculates the total protocol-related charges for a study and the total cost of all subject-related charges for one subject who completes the entire study.

The Budget Calendar report provides a calendar view of all charges incurred during each subject visit. Total charges for each visit and for each procedure are calculated, as well as the overall total cost for a subject who completes the study.

Want to learn more?

The Budget Compare report compares the current negotiated costs of a longrunning study to the current costs in the Charge Master. If a protocol has been open for many years, the original negotiated amounts might no longer cover the actual costs incurred by your organization.

Learn more about the Budget

Compare report on the

Financials Console /Subject

Related page of the Learning

Portal.

Run the Budget Calendar report

1.

Click the Budget Calendar button.

2.

To include costs for all arms and all sponsors on the study, leave the

Protocol

Arm and Protocol Sponsor fields blank.

3.

Select Negotiated in the Use Cost field.

4.

Select the checkbox to Display Overhead/Indirect Charges?

5.

Click Calendar to run the report.

Financial Budgeting | Page 28 of 37

Analyze the budget calendar

Charges for each event are shown in the calendar grid when the corresponding procedures occur on a subject visit.

Charges for Standard of Care procedures are replaced by an “S” instead in the calendar grid.

Total costs for each subject visit are shown at the bottom of the visit’s column.

Total costs for each procedure are shown in the far-right column.

Based on the report parameters, the indirect/overhead cost for each subject visit is calculated and is included in the total cost of the visit.

If there are multiple treatment arms on the protocol, each arm will have its own budget calendar grid. Notice that the cost of a subject on Arm B is less than the cost of a subject on Arm A because the treatment administration charge is higher for Arm A visits.

Financial Budgeting | Page 29 of 37

Configuring Billable Milestones

The final “pre-award” task when setting up a protocol budget in OnCore is to choose billable milestones. Milestones are required for sponsor invoicing in OnCore; milestones are specific events or subjects statuses that can be added to an invoice once they are achieved.

1.

Navigate to the Financials Console > Milestones tab.

2.

Click Update (if needed) then click Select.

3.

Select all subject events, statuses, and visits that should be invoiceable to the sponsor for this study.

Example: select the checkboxes for Screen Failed, SAEs, and OSRs.

 Example: select the checkboxes for

all subject visits.

NOTE: If most milestones will be invoiceable during this study, save time by clicking Select All and then un-selecting the milestones that are not applicable for this protocol.

4.

Click Submit.

All selected milestones appear in the Financials Console. If possible, the Total

Negotiated Costs appear next to each selected visit milestone.

5.

To accept the calculated costs for each milestone visit (based on the procedures scheduled at each visit with a charge type of “Milestone”) scroll to the bottom of the screen and click Default Charges.

6.

Enter the Negotiated Amount for subject statuses or events that do not have a calculated cost.

 Example: the sponsor agrees to reimburse $25 for each screen failure, $125 for each SAE, and

$250 for each OSR (according to the ratios set in the

Parameters tab).

Financial Budgeting | Page 30 of 37

7.

Click Submit.

NOTE: Sometimes, a standard cost per visit is negotiated with the sponsor, instead of negotiating at the event level. If the sponsor has agreed to pay different amounts than what is calculated in OnCore, simply override the calculated values with the negotiated milestone costs. The sponsor invoices will show the expected amounts for occurred subject visits.

Some of the milestones might have a calculated cost of $0. If this is the case, the charge can be manually entered in the Negotiated Amount field, or the milestone can be removed using the Delete? checkbox.

If a visit has charges associated with it but the sponsor does not want an invoice generated for that visit, delete the visit from the list of milestones. The costs will be rolled-up into the next milestone, as long as the visits are part of the same segment.

Financial Budgeting | Page 31 of 37

Releasing and Updating Protocol Budgets

A budget must be released in order to generate invoiceable items when subject visits occur and subject statuses are achieved. The clinical calendar (schedule of events) must also be released in order to generate individual calendars for subjects enrolled on the study.

Because the clinical calendar and the protocol budget are so intricately linked, the budget is automatically released when the clinical calendar is released. The first time the protocol calendar is released, calendar version 1 (V1) and budget V1 are created simultaneously.

After the initial calendar + budget are released, the budget can be updated without creating another version of the clinical calendar. This is advantageous because creating a new clinical calendar either requires upgrading existing subjects to the new calendar version, or maintaining two schedules of events (calendar V1 and V2) for the rest of the study.

At any point in the future, if the clinical calendar is updated (due to an amendment, etc) and a new calendar version is released, a new budget is automatically released with it.

So, a protocol can have one or more released calendar versions, and each calendar versions can have one or more released budget versions associated with it.

Financial Budgeting | Page 32 of 37

A sample timeline of updates to a protocol budget

Jan 2014

Protocol created in OnCore; clinical calendar is built

Feb 2014 Coverage analysis is performed

Mar 2014

Budget is created; all teams sign off on the study calendar and budget

Apr 2014

Initial calendar and budget are released

--

--

--

Calendar V1

Sep 2014

Milestone costs for follow-up visits need to be increased by 5% - new budget version is released

Calendar V1

Nov 2014

Amendment to protocol received from sponsor – new calendar version is released

**A new budget version is automatically released as well

Calendar V2

--

--

--

Budget V1

Budget V2

Budget V1

Financial Budgeting | Page 33 of 37

Each time a new calendar is released, a new initial budget is released with it. The initial budget released with a new calendar version is always budget V1. Updated budget versions can be released while the calendar remains on V1, but if calendar V2 is released, a second (new) budget V1 is released with it.

IMPORTANT

If there are multiple released versions of a calendar, there will be multiple

“Version 1” budgets as well.

Financial Budgeting | Page 34 of 37

Release an initial calendar + budget

When the clinical calendar is complete and the costs for budget events and milestones are finalized, the initial calendar and budget are released via eCRFs/Calendars >

Specifications.

1.

Navigate to eCRFs/Calendars > Specifications.

 If you are already in the context of a protocol, the protocol specification

(calendar of events) appears, skip to step 5.

 If you have not been working in a particular protocol during this OnCore session, open the specification whose calendar + budget needs to be released:

2.

Click Protocol Specifications.

3.

Click the Protocol No. to open the specification.

4.

Click Calendar.

5.

Click Complete.

Marking a calendar as “Complete” indicates that no more changes will be made to the schedule of events. “Completing” a calendar is not the same as “Releasing” a calendar; there are additional required steps to release the initial calendar + budget.

Because the initial calendar and initial budget version are always released together, several teams might want to review each protocol specification before it is released. Signoffs are required after a calendar is marked as Complete, before the

Release button appears. Signoffs are created by a script provided by the Forte engineering team, and can be configured (enabled or disabled) by library.

Only users with the appropriate privileges can document signoffs for protocol calendars.

Financial Budgeting | Page 35 of 37

6.

Complete any required protocol specification signoffs by clicking the Signoff button(s).

 Click Biostatistician Signoff.

7.

Click Release.

The initial calendar and budget are now released (calendar V1 + budget V1). No further changes can be made to the schedule of events, protocol-related budget events, subject-related budget events, or invoiceable milestones unless a new version of the budget or calendar is created.

Create a new budget version without creating a new calendar version

If changes need to be made to a budget but the schedule of subject visits and procedures should remain the same, create a new version of the budget:

1.

Navigate to Financials > Financials Console.

2.

Click Subject Related.

3.

Click New Budget Version.

You must choose to lock budget events, or leave budget events unlocked.

Financial Budgeting | Page 36 of 37

If you lock the budget events, you can only make limited changes to the budget.

Changes will take effect on already occurred visits if you enter a past date as

the Effective Date for this new budget. The list of retroactively impacted visits is shown before the new budget version is released.

If you do not lock the budget events, the

Effective Date must be a current or future

Want to learn more?

Find out more about locked vs. unlocked budget events (and what changes can be made when budget events are locked) on the Financials Console

/Subject Related page of the

Learning Portal. date. Retroactive changes are not applied to visits checked in prior to the release of the new budget version.

4.

Select

No, do not lock budget events. Occurred visits will not be updated

retroactively.

Any changes can be made to the new budget version, including updating costs, linking Charge Master events, changing charge types, or adding/removing

Milestones.

5.

When the new budget version is ready to be released, enter an Effective Date of t and click Release Budget.

This new budget version will apply to visits checked in from this point forward.

Financial Budgeting | Page 37 of 37

Subject Administration

Subject Administration

The focus of this training section is on subjects. In OnCore, a subject is a person who is participating in a protocol or may participate in a protocol. There are two consoles used in subject management: the Subject Console and the CRA Console.

The Subject Console

The Subject Console allows you to view subject information within the context of a protocol. The console provides access to a subject’s demographic information, the protocols the subject is associated with, what consent forms the subject has signed, their eligibility status, etc.

The CRA Console

The CRA Console is designed to provide subject information at a protocol level. When a protocol is selected in the CRA Console, it displays the subjects who have been accrued, which subject forms have been completed and are yet to be completed, a list of Serious Adverse Events (SAEs), visits outside of tolerance, and other subject deviations in this protocol.

It is quite easy to move from one console to the other. The CRA Console lists the subjects associated with the current protocol, and each subject links to the corresponding subject in the Subject Console. Conversely, the Subject Console has a vertical tab to transfer to the CRA Console.

As you manage subjects, you will move between these consoles. This manual covers the basic tasks when dealing with a subject: registering the subject, logging consent information, and placing the subject on study. An important part of this discussion will be centered on entering data, especially key dates.

Subject Administration | Page 1 of 17

Registering Subjects

The first task is to create a new subject. Subjects must be associated with a protocol.

Register an existing subject

1.

Navigate to Subjects > CRA Console.

2.

In the Select Protocol field, select your protocol: PROT-your initials.

3.

Click the New Subject Registration tab.

The New Subject Registration page allows you to search for existing subjects or add a new subject. Note that you are still working within the context of your protocol; a subject cannot be entered into OnCore without a protocol association.

4.

In the Study Site field, choose the Outstanding Research Center.

This field indicates the location where the subject is enrolled. This is a find-as-you-type field that allows you to choose among the study sites participating in this protocol at your institution (or an institution with which you are affiliated).

5.

When entering a new subject, first check to see whether they have already been entered into OnCore, in order to avoid duplicate subject entries. In the

Find Fields

section on the left, enter Smith in the Last Name field and click Find.

The Subject Find Results table shows all subjects matching the search criteria.

Subject MRN displays as a link; clicking this link populates the fields in the New

Subject screen with the selected subject’s data.

For this exercise, do not select from this list; instead, the next section shows you how to create a new subject record.

Good to know

The Subject Find Results table shows subject records that already exist in OnCore. These subjects are either already associated with another protocol or have been loaded into

OnCore via a demographics interface with your organization’s EMR.

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Subject Administration | Page 2 of 17

Register a new subject

If the subject does not yet exist in OnCore, you will need to create a new subject record.

1.

On the New Subject Registration page, click Clear All.

2.

In the Study Site field, select Outstanding Research Center.

3.

Enter the following into the New Subject Details section:

4.

Subject MRN: your initials123

Last Name: your choice

Birth Date:

your choice

First Name: your choice

Gender:

Race:

Click

Ethnicity:

Add to register the new subject to the protocol.

your choice

your choice

your choice

Good to know

It is possible to customize the display of the Subject MRN label. If you do not want this identifier to be referred to as an

MRN, consult your Forte Project

Manager or Product Specialist.

It is also possible to configure

OnCore so that the SSN field is hidden, if you do not intend to collect this information.

The Subject Console page opens on the

Demographics tab. Note that the subject demographic information you entered appears on the page.

Updating subject demographics

Subject demographic information is updated on the Subject Console > Demographics tab of the Subject Console. Clicking Update allows you to make changes to a subject’s demographic and contact information.

Subject Contact Information

This section is where you record contact information, such as address, phone number, and e-mail address, and the subject’s emergency contacts. This information may be kept in OnCore or it may be kept in another electronic registration system.

Subject Administration | Page 3 of 17

Additional Subject Identifiers

This section lists identifiers for the subject other than the MRN. Information in the

Identifier Type field is selected from a pre-defined list (a Domain); free text can be entered in both the Identifier and Identifier Owner fields. An example of an additional subject identifier is a Hospital ID from another system.

Managing Subjects

Subjects in OnCore may progress through several statuses during the course of the protocol. The vertical tabs in the Subject Console (Consent, Eligibility, On Study,

Treatment, Follow-Up) allow you to record this status information.

Enter subject consent

Since you have already selected a subject, the Subject Console header displays the

Protocol, Protocol Status, the Subject's MRN, and Subject Name. Note that the subject does not yet have a subject status. In the next procedure, you will set the subject’s status as having consented to the protocol.

1.

Select the Consent vertical tab.

The Existing Consents section will list signed consent forms for this subject .

Since this is a new registration, the message “No Subject Consent Found” appears in the

Consents section because no consent forms have yet been signed.

2.

Click Update.

3.

In the Signed Date field, enter w-20, and then click Select Consents.

A list of available consents opens, showing consent forms for the subject that have been approved at the subject’s study site and added at the protocol level via PC

Console > Reviews > IRB record, or if an affiliate study site, via Institution > select

an institution > Consent Forms tab.

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Subject Administration | Page 4 of 17

4.

Select Accepted, and then click Save.

The consent form information appears along with the subject's signed date. Note that the Subject Status field at the top of the page has been updated to

CONSENTED.

The Other Consent Status table records comments related to consent information, consents being refused, or waived, or withdrawn; and reconsents when a minor subject has reached the legal age.

5.

Click Close.

Recording Reconsent

When a newer consent is available for a subject to sign (a new consent was approved in an IRB review and indicated as Reconsent Required), an RR superscript appears next to the consent type (such as Treatment Consent

RR

). This superscript also appears next to the Subject MRN on the CRA Console > Accrual tab. OnCore does not restrict your ability to add treatment information, but the RR will not go away until the reconsent is recorded or marked as not applicable.

When a subject requires reconsent, follow the procedure described above in “Entering a consent,” and then add the newer version of the consent for the subject.

Alternatively, you can indicate that the reconsent is not applicable to the subject. On the

Subject Console > Consent tab, select the consent link that includes the RR superscript.

A box will open that allows you to indicate that reconsenting is not applicable. If you make this choice, the superscript will change to N/A (for example,

Treatment Consent

NA

).

Make a subject eligible

Confirming a subject’s eligibility is not required by OnCore prior to placing that subject

On Study, but it is generally done. To confirm a subject’s eligibility, use the following procedure:

Subject Administration | Page 5 of 17

1.

Navigate to Subject Console > Eligibility.

The Eligibility tab is used in one of two ways, depending on how the protocol was set up:

 To record the subject’s eligibility status and the date of that status

 To supply the answers to a predefined eligibility questionnaire that helps users to determine the subject’s eligibility status. This questionnaire is defined per protocol in the PC Console > Eligibility tab.

2.

Your example protocol has a questionnaire. To record the subject’s responses, click Update.

The eligibility questionnaire appears. Note that the questions are followed by Yes and No buttons labeled red or green. A red answer indicates ineligibility.

3.

Enter the following:

Verified By: your initials

Status Date: w-18

Eligibility Questions: provide the answers that make the subject eligible

4.

Click Submit.

Note that the Subject Status has been changed to ELIGIBLE.

5.

Click Close.

Place a subject on study

Our subject has a recorded consent and a status of Eligible. The next step is to place our subject On Study.

1.

Navigate to Subjects > Subject Console > On Study and click Update.

At the top right of the page is the Sequence No., a number unique to each subject within the protocol. The sequence number may be manually entered or it can be generated automatically by OnCore. Your training protocol has been configured for

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Subject Administration | Page 6 of 17

automatic sequence number. By default, automated sequence numbers start with the number 1, but the numbering scheme can be defined by the protocol.

2.

One of the most important fields is On Study Date. The presence of this date is what OnCore uses to determine subject accrual to the protocol. Enter an

On Study

Date of w-16.

The Diagnosis (Disease Site and Histology

*

) fields contain drop-down lists based on the values entered in the PC Console > Treatment > Diagnosis tab. The values that appear in the case of an Oncology protocol are defined in the NCI Data Table

3 Primary Disease Site mapping guidelines.

3.

Make your selections for Primary and Secondary Diagnosis fields as appropriate:

Non-Oncology Oncology

Primary Diagnosis: Heart Disease

Secondary Diagnosis: Leave blank or

click into the attached drop-down list, select View All, and then choose a

diagnosis from the pop-up window.

Disease Site: Bronchus and Lung

Histology: Carcinoma, NOS

Oncology Group: select the group that

should receive accrual credit for the subject (defaults to the Primary Oncology

Group indicated on the PC Console >

Main > Management tab)

4.

In this example, do not edit the Study Site and or enter a Transferred Date.

The Study Site field is populated with the study site selected during the new subject registration process. Clicking the browse icon next to the field displays all the study sites participating in the study.

The Transferred Date field indicates the date that a subject who was enrolled on the protocol at another institution was transferred to the study site.

5.

Click

Submit.

*

Oncology library specific

Subject Administration | Page 7 of 17

Note that the Subject Status has been changed to ON STUDY and a Sequence

Number has been assigned.

6.

The Additional Protocol Subject Identifiers section contains identifiers for the subject applicable to this protocol. Enter the following, and then click Add

Identifier Type: choose any

Identifier: type any value, using letters and/or numbers as desired

Add subject staff

The Subject Staff section on the Subject Console > On Study page holds information about the treatment staff assigned to the subject.

1.

Enter the following staff information from the drop-down lists attached to each field:

Role: Treating Physician (if unavailable, choose any role)

Staff Name: choose any

2.

Click the Add button.

When staff members have been added to the subject record, their first and last names appear as links in the Subject Staff section. In view-only mode, selecting the name link displays a staff member’s contact information. In update mode, selecting the name link opens a window where additional staff information may be added, or where the staff member can be deleted.

3.

Click See All to display additional subject staff fields.

Staff with a past Stop Date will appear as well.

4.

Click Team to create subject staff from the already-defined Protocol Staff list.

5.

Add yourself as a subject staff with the Clinical Research Associate role.

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Subject Administration | Page 8 of 17

Place a subject on treatment

In the Subject Console, the Treatment tab allows you to select the protocol arm assigned to the subject. You can also enter additional dates used in subject visit scheduling.

1.

Select the Treatment tab, and then click Add.

2.

Enter the following information:

Arm: Arm A

On Arm Date: w-15

On Treatment Date: w-15

Click Save.

Notice that the Subject Status in the upper right of the page changed to

ON TREATMENT.

As you’ve been doing these steps, visits have been populating on the subject’s calendar

(if a calendar has been created for the protocol). The planned dates for the visits in the calendar are relative to the dates entered for each individual subject.

Enter Off Treatment, On Follow Up, and Off Study statuses

Additional subject statuses are available after On Treatment, including Off Treatment,

On Follow Up, and Off Study. These statuses can also be triggers for visits in the subject calendar. If the protocol doesn’t have a follow up portion, the On Follow Up status isn’t required.

The following instructions show you how to enter these statuses as an exercise, but you will remove the statuses in the final step in order to avoid problems with the subject calendar.

1.

Click the Follow-Up tab, and then click Update (if necessary).

2.

In the

Off Treatment Date field, type w-5 and click Submit.

Subject Administration | Page 9 of 17

Note the change in Subject Status; the subject is now OFF TREATMENT. This page also has a field for the Off Treatment Reason and a field for a free-text note.

3.

In the Follow-Up Start Date field, type w-4 and click Submit.

Note that the Subject Status has changed to ON FOLLOW UP. If you are using a protocol calendar, treatment visits with

Planned Dates after the Follow-Up Start

Date will no longer be available to be checked in.

There are additional fields in the Subject

Follow-Up Update section, some related to tracking follow-ups without a calendar and others related to the last known status of the subject. The Expired Date field appears here in addition to being on the

Demographics tab.

Want to learn more?

The Expired Date field can be configured to allow the entered expired date to cascade down to the Off Treatment Date and

Off Study Date fields. This feature will function the same way for all protocols to which the subject is associated. For more information, see the

Expired Subject Workflow on the Configuration Options page of the Learning Portal.

4.

Enter an Off Study Date of t-20 and click the Submit button.

Note that the Subject Status has changed to OFF STUDY. You do not want your subject to be Off Study at this point, however.

5.

Remove the Off Treatment Date, Off Study Date, and Follow-Up Start Date and any Reasons you may have entered. Then, click Submit.

Note that the Subject Status has returned to ON TREATMENT.

Create a Serious Adverse Event (SAE)

The SAEs tab in the Subject Console records any serious adverse events associated with a subject. SAEs must be entered at the subject level; however, SAEs can be viewed across all subjects at the protocol level in the CRA Console.

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Subject Administration | Page 10 of 17

1.

Navigate to Subjects > Subject Console > SAEs tab and click New.

2.

In the Subject SAE Update section, type the following information in the required fields listed below:

Event Date: w-8

Reported Date: w-7

Protocol Attribution: Possible

Outcome: Recovering/Resolving

NOTE: The Event Date must be on or after the subject’s Consent Date.

3.

Click Submit.

Upon submission, an Event Number will be assigned to the SAE. This unique number appears at the top of the page.

4.

SAEs can be locked when you are finished to prevent edits to all but the Tracking

Details section. Click Complete and Lock.

NOTE: Even though the SAE has been locked, you have the ability to update the

Tracking Details section of the SAE and to create a follow-up SAE.

The following optional sections of an SAE allow you to track additional details, if desired:

Want to learn more?

SAE Classification

Allows you to select one or multiple SAE classifications from a drop-down list.

See the Subject_Console/SAEs page of the Learning Portal more information on recording and tracking SAEs.

Adverse Event Details

This section is optional, but if information is entered in this section, all required fields must be filled before clicking Add.

Tracking Details

Records the dissemination of information regarding the SAE.

Subject Administration | Page 11 of 17

Additional SAE Identifiers

Records other identifiers for the SAE, such as a number assigned by the IRB. An

Identifier Type can be selected from the drop-down list, and free text may be entered into the Identifier and Identifier Owner fields.

Supporting Documents

Allows you to upload files relevant to the SAE

Create a follow-up SAE

OnCore allows you to create a follow-up to an existing SAE. The follow-up SAE copies most of the parent record’s information; you can then make modifications as needed

(most commonly this involves changes to the Outcome field).

1.

Select the SAEs tab and click on the SAE’s Event No. link.

2.

Click Create Follow-Up.

A follow-up SAE is created and a new Event No. is assigned to this SAE. The

Event No. of the parent SAE appears next to it in parentheses. The Follow-Up

Number appears on the right side of the header band.

3.

Enter the following:

Reported Date: w-6

Outcome: Intervention for AE Continues

4.

Click Submit to save your entries, and then click the SAEs vertical tab.

You can see that the Event No. of the SAE shows its relationship to the parent.

NOTE: The follow-up SAE has a Delete link in the Delete column but its parent

SAE does not. When SAEs are deleted, they must be deleted in reverse order of creation (the child SAE must be deleted before the parent SAE).

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Subject Administration | Page 12 of 17

Create a subject deviation

A deviation is a variance from the approved protocol procedures. Deviations specific to an individual subject are entered via the Subject Console > Deviations tab.

1.

Navigate to the

Subject Console >

Deviations tab.

Good to know

The table at the top of the page shows the subject’s deviations. The bottom table shows any visits with a visit date outside of the planned date’s tolerance. This table is for informational purposes and you can use it as a guide for entering deviations if needed.

If you ever have a hard time finding the Subject Console, remember that it is accessed via the CRA Console. Navigate to

Subjects > CRA Console, select your protocol, and then find your subject in the subject list on the

Accrual tab. Click the subject name to open the Subject

Console.

2.

Click New to create a deviation.

The Date Discovered and Reported By fields default to the current date and user, but may be changed. When entering Deviation data, the required fields are marked with an asterisk.

3.

Enter the following:

Date Discovered: keep the default (the current day)

Reported By: keep the default (your user name)

Deviation Date: w-6

Category: Treatment

Description of Deviation: Missed a procedure on a visit

4.

Click Submit to create the deviation.

Other information may be entered to record when it should be reported to IRB, the date it was reported, and the date it was reported to the sponsor.

5.

Click the Deviations vertical tab to see the updated display.

The Delete link allows you to delete a deviation record entered in error.

Subject Administration | Page 13 of 17

Tracking Pre-Screenings

OnCore supplies a way to track pre-screening efforts for potential subjects and the time spent pre-screening these candidates. The information captured includes subject referral data, subject characteristic data, and protocol evaluation specifics.

Create a Screening Record

1.

Navigate to Subjects > Pre-Screening.

The initial page is a search tool. See the “Search the pre-screening database” section for instructions on how to use this tool.

2.

Click New to create a new pre-screening record.

The Referral Information table is where you can record Referral and Contact

Information. The fields are straightforward. The Contact Date is required.

3.

Choose a Management Group.

4.

Enter today’s date as the Contact Date.

5.

In the Referral Channel field, select Newspaper.

A new entry field will appear, allowing you to supply which newspaper was used.

6.

Select an item from Referral Details.

7.

The next section records Subject Characteristics. All data entry fields are optional.

Enter a Subject Identifier and select one or more Race checkboxes.

8.

Click Submit.

Visit the OnCore Learning Portal at http://docs.onsemble.net

Subject Administration | Page 14 of 17

Add a pre-screening subject to a protocol

After the potential subject has been evaluated, evaluation data can be entered in the bottom portion of the screen.

1.

Select Yes for Subject Evaluated?

2.

Select your protocol number in the Protocol No. field.

3.

Select Yes for Subject Consented?, then click elsewhere in the screen.

When a Protocol No. is entered and the patient is listed as having consented, the

Add Subject to Protocol button appears.

4.

Click Add Subject to Protocol.

You are transferred to the New Subject registration screen. On this page you can add a new subject to the protocol. (We will not.)

5.

Return to the search page via the Subjects > Pre-Screening menu item.

Search the pre-screening database

Now that you've seen the Screening entry page, the initial search page makes sense.

It's a typical search page.

Here you may enter or select data in the various fields to narrow your search. Let’s see the pre-screening record you just entered.

1.

Select your name in the Entered By field and click Submit.

The Search Results screen displays the search criteria in the header, and the found records in a table below. The column headers in the table are hyperlinks- click them to sort the records by that column.

2.

Click the Pre-Screening ID link. This will display the Pre-Screening Record. Click

Update.

Subject Administration | Page 15 of 17

Additional fields allow you to indicate who did the evaluation and the time it took, if the patient is eligible. After the patient goes On Study, the Patient On Study and

Record Completed fields may be set to Yes. You may enter additional information in the Subject Notes section that will appear at the bottom of the page.

3.

Click Submit to save the information, and then click Close.

Visit the OnCore Learning Portal at http://docs.onsemble.net

Subject Administration | Page 16 of 17

4/15/2015 Subject Visit Tracking and Forms - OnCore Documentation

Subject Visit Tracking and Forms

Alternate Versions

13.5 13.0

edit

Page Contents

1 Subject Visit Tracking & Forms

1.1 Subjects and Consoles

1.2 Subject Calendars

1.3 Calendar Versions

1.4 Verifying Subject Visits

1.5 Additional Visits

1.6 Subject Forms

Subject Visit Tracking & Forms

This document describes OnCore subject visit tracking and subject forms. Depending upon the configuration of your OnCore system, you may not have all of the options, functions, and data access described in this document. Please contact your OnCore Administrator for further information.

Subjects and Consoles

In OnCore, a subject is a person who is participating in a Protocol or may participate in a Protocol. There are two consoles used in subject management - the Subject

Console and the CRA (Clinical Research Associate) Console.

The Subject Console is designed with a Subject focus. The console provides access to a subject’s demographic information, the Protocols the subject is associated with, what consents the subject has signed, what is their eligibility status, etc.

The CRA Console is designed to provide Subject information at a Protocol level. When a protocol is selected in the CRA Console it displays the subjects that have been accrued, which subject forms have been completed and are yet to be completed, a list of SAEs (Serious Adverse Events), visits outside of tolerance and protocol deviations in this protocol. It is quite easy to move from one Console to the other. The CRA Console lists the subjects associated with the current protocol, and each subject has a link to display the subject in the Subject Console. Conversely, the Subject Console has a vertical tab to transfer to the CRA Console.

Subject Calendars

This Overview assumes that a protocol and protocol calendar have already been set up for your protocol. The protocol calendar defines a schedule of visits (when a subject is to be seen) and what treatment will be done during each visit.

All sample data is based on information entered in the PC Console as directed from the Protocol Administration Overview and the Specifications Overview. Screenshots may not be consistent with the sample data in this overview, and are meant to be visual aids only.

To view a subject calendar, select the Calendar vertical tab in the Subject Console.

Subject Calendar Activation

In order to record subject visit information, the calendar segments containing the visit must be activated. Activation occurs when anchor dates for the subject are entered into OnCore. The anchor dates that can be used to define a calendar segment are 'Consent Signed', 'On Study', 'On Arm', 'On Treatment', 'Off Arm', 'Off Treatment', 'Off

Study' and 'End of Previous'.

When an anchor date is entered for a subject, the calendar segments based upon the date become active and a Planned Date will be calculated for the visits in the segment.

For treatment segments based upon 'End of Previous', the system calculates Planned Dates relative to the last date of the segment preceding it (segments are ordered by a

Sequence Number).

Here is an example of a subject calendar before an anchor date is entered:

Subject Calendar with no anchor dates entered: file:///C:/Users/leya/Downloads/Subject%20Visit%20Tracking%20and%20Forms%20-%20OnCore%20Documentation.htm

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Note that in version 13, the ability to see the Forms column is controlled by a separate privilege (Subject Calendar View Forms), without which, the column will not appear.

Here is the calendar with the Consent Signed date entered, which anchors the Screening segment:

Subject Calendar with Screening visit anchored to Consent Signed date:

When a segment is active, the visit labels of the segment become links. Click a link to display the visit’s Subject Visit Update page where you can verify the date the subject was seen and enter visit specific information (see the Verify Subject Visits section later in this document).

Hovering your cursor over a date in the Planned Date row of the subject calendar will display the date’s day of the week.

A procedure’s row will display with a gray background in the subject calendar when the procedure is retired in the version of the Charge Master that the version of the calendar is linked to.

Calendar Viewing Options

Toggle Full Screen

The view the calendar in a full screen, click the Toggle Full Screen link. Click the link again to return to the standard view.

Freeze Panes

Clicking the [Freeze Panes] button allows you to vertically scroll the calendar without losing the column and row header information. Click the [Unfreeze Panes] button to return to normal scrolling. If you turn on Freeze Panes, all Subject Calendars will display as ‘freeze panes’ until you click the [Unfreeze Panes] button.

Summary View

If a calendar has many visits, the scroll bar at the bottom appears. Clicking the [Summary] button will limit the display to show the last visits marked as Occurred and the next nine visits. Click the [Full Calendar] button to return to the normal display. If you turn on the Summary View, all Subject Calendars will show in the Summary View until you click the [Full Calendar] button.

file:///C:/Users/leya/Downloads/Subject%20Visit%20Tracking%20and%20Forms%20-%20OnCore%20Documentation.htm

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Note: Showing ten total visits is the default option, but it is a configuration choice that can be changed.

View PDF

The [View PDF] button will generate a PDF containing the last Occurred visit plus a number of future visits. The total number of visits in the PDF depends upon the value in the Number Of Visits field.

View Excel

The [View Excel] button exports the calendar to an Excel spreadsheet.

Export Forms

The [Export Forms] button exports the forms for any calendar visit. Clicking the button displays a window where any active visit may be selected. Once a visit is selected, the forms associated with that visit appear with checkboxes allowing you to select them for inclusion in the export.

Subject Calendar > Export Forms:

Checkboxes provide options when exporting the forms.

Export Options:

Occurred Visits Only

Select the checkbox to limit the export to forms associated with occurred visits only.

Include Footnotes

The footnotes defined in the Specification will appear under the appropriate form in the export.

Include Form Notes

The form notes/completion instructions defined in the form configuration will appear under the appropriate form in the export.

Enumerate List Items

The option list values used on the form will appear in the export.

Include Change History

Select the checkbox to include the Change History for the form on the top of the export.

Printable Subject Calendar

At the bottom of the calendar display is the Printable Subject Calendar link. Selecting the link displays a monthly calendar of the subject’s visits.

Printable Subject Calendar: file:///C:/Users/leya/Downloads/Subject%20Visit%20Tracking%20and%20Forms%20-%20OnCore%20Documentation.htm

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The calendar is generated for the current month and has arrows in the upper corners to navigate to other months. If a Visit Tolerance exists for a visit, a label Tolerance: +/-

# will appear for the visit.

You can add notes by clicking on the bolded number of the visit date. Once the note is entered, it will be visible only on the Printable Subject calendar.

file:///C:/Users/leya/Downloads/Subject%20Visit%20Tracking%20and%20Forms%20-%20OnCore%20Documentation.htm

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The calendar for a month can be exported to an Excel spreadsheet by clicking the Export link at the top of the page. Return to the Subject Console calendar page by clicking the Back to: Subject Calendar link.

Calendar Versions

Studies can have multiple calendar versions. When a new version of a subject calendar is available, you have the ability to switch the subject to a later version than the subject’s current version. (The ability to change a subject’s calendar version is controlled by a security privilege. These changes can also be made in bulk on the CRA

Console > Accrual tab.)

Switching Calendar Versions

The subject’s current calendar version is noted in the subject calendar header. When a newer calendar version is available, the subject calendar will have a Switch Version drop-down box.

Subject Console; Calendar; Switch Version: file:///C:/Users/leya/Downloads/Subject%20Visit%20Tracking%20and%20Forms%20-%20OnCore%20Documentation.htm

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If a new version is selected, the calendar displays a preview of the new version and a [Replace Version] button displays. Click the button to confirm the change.

Verified Visits and New Calendar Versions

In a new calendar version, visit procedures may be added or removed. If a visit has been verified prior to switching the calendar version, the new subject calendar display reflects this change.

In the scheduling grid, the subject calendar displays an 'X' for the procedure with a subscript 'A' or 'D'. The 'A' subscript indicates that a procedure that was not performed as part of the original visit schedule has been added to the calendar, the 'D' subscript indicates that a procedure that was performed as part of the original visit schedule has been deleted from the calendar.

If a visit was entirely removed from the schedule in a new version of the calendar and that visit has already been verified, the visit will show on the Orphaned Visits tab on the Subject Calendar.

Subject Console; Calendar; Orphaned Visits:

Verifying Subject Visits

Basic Verification

After a Subject Calendar segment has been activated, subject visit information can be entered (see the previous Subject Calendar Activation section). This is called verifying the visit.

To verify a visit, start by clicking the visit name link (which is displayed above the visit date). This will display the Subject Visit Update page.

Subject Visit Update page: file:///C:/Users/leya/Downloads/Subject%20Visit%20Tracking%20and%20Forms%20-%20OnCore%20Documentation.htm

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All that is required to verify the visit is to enter a Visit Date, (which defaults to the Planned Date shown on the subject calendar), select one of the 'Visit Status' radio buttons, and click the [Submit] button.

Once the visit has been submitted, additional buttons will become available:

Note that the Delete button is inactivated once a visit has been included on an invoice. If the invoice is voided, the button will be activated once again (unless the visit is an

additional visit).

If the 'Occurred' radio button is selected and the page submitted, the Subject Calendar will show a Visit Status of 'Occurred' and the Visit Date will display. Any procedure forms for the visit will populate the Subject Console > Forms By Status > To Do Forms tab.

After a visit has been marked as Occurred, the visit’s calendar version and financial budget version date will be displayed along with the Phase and Visit description on the right side of the Visit Details header band toward the top of the Subject Visit Update page.

The Subject Visit Update page displays a procedure in gray if the procedure is retired for the version applicable to the visit.

Additional Visit Details: 

Besides verifying the Visit Date, there are additional features available in the Subject Visit Update page.

Additional Visit Statuses

Missed

Used to indicate that the subject missed the particular visit. If selected, the Visit Date field will clear. Marking a visit as Missed results in a visit variation in the

Financials Console.

NA

Used to indicate that this visit does not apply for this specific subject. Marking a visit as NA will results in a visit variation in the Financials Console.

Planned

May be used to enter notes and comments for the visit.

For an Occurred visit, the subject calendar displays the Visit Date and Visit Status in black. For a Missed or N/A visit, these values are in red. When a visit is marked as

Planned (meaning the visit has not been verified), the values appear in blue.

file:///C:/Users/leya/Downloads/Subject%20Visit%20Tracking%20and%20Forms%20-%20OnCore%20Documentation.htm

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Visit Description

Enter details about the visit.

Subject Visit Tracking and Forms - OnCore Documentation

Reset Calendar?

Select whether, and by which means, future visit dates should be adjusted if the Visit Date was not the Planned Date. Future visit dates will be adjusted with the same offset from the scheduled date as the current visit. The Reset Calendar functionality is available for the treatment and follow-up portions of the calendar when cyclical schedules are being used.

The following four fields are used by the Financials Console:

Data Collection Completed Date:

When the data collection for the visit is complete, enter the completion date. The status of 'Completed' is displayed in the Status column of the Financials Console,

Invoiceable Items tab, with the date in the Status Date column.

Monitored Date:

When the data has been monitored, enter the monitored date. The status of 'Monitored' is displayed in the Status column of the Financials Console, Invoiceable Items tab, with the date in the Status Date column.

Submitted Date:

When the data has been submitted to the sponsor, enter that as the submitted date. The status of 'Submitted' is displayed in the Status column of the Financials Console,

Invoiceable Items tab, with the date in the Status Date column.

Locked Date:

The date the data is locked, meaning no more changes/alterations are allowed to the data. (The Locked Date is an informational field and does not affect the data entry status of the fields on the subject.)

If OnCore configuration UNCERTIFY has been enabled, you may ‘uncertify’ a visit after it has been verified. Otherwise the [Delete] button will be available if all forms are in the To Do status and the visit has not been invoiced.

Collection Location:

Select the location of correlative specimen collection for the visit from the predefined list. The drop-down will be populated with a default from the PC Console > Specimen

Collection Configuration tab if available.

Collection Time:

Enter the projected correlative specimen location time. This will be populated with a default from the PC Console > Specimen Collection Configuration tab if available.

The Collection Location and Collection Time are shown on the BSM Planned Visits Report.

Clinical Comments:

Enter clinical comments here. When clinical comments are entered, a (C) will display on the subject calendar next to the visit number. By moving the mouse over the (C), the comments preceded by the title ‘Clinical Comments’ will be visible.

Data Comments:

Enter data comments here. When data comments are entered, a (C) will display on the subject calendar next to the visit number. By moving the mouse over the (C), the comments preceded by the title ‘Data Comments’ will be visible.

Subject Calendar indicating clinical comments on visit 1:

Procedures Table file:///C:/Users/leya/Downloads/Subject%20Visit%20Tracking%20and%20Forms%20-%20OnCore%20Documentation.htm

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The procedures table allows you to enter information specific to the procedures scheduled for the visit. Changing the fields listed below (except Procedure Date) from the default state and adding additional procedures will flow through to the Financials Console > Visit Variations tab for the financial team to see. If a visit variation occurs, a modal window will appear to provide a free text field to record the variation’s Reason for Change.

Once the Reason For Change window is saved, the procedure will appear as a link allowing access to the Reason for Change comment. This reason will also appear in the

Financials Console, Visit Variation list.

Procedure Date:

Only enter a date if the date of a procedure is different than the Visit Date. Changes to the Procedure Date will not cause Visit Variations in the Financial Console.

SOC:

Check the SOC (standard of care) box if the procedure is standard of care. This field is used in conjunction with the Financials Console, where the procedure is specified to be SOC or non-SOC for all subjects on this study on a visit basis. Changing the default checked or unchecked status of this checkbox will result in a visit variation in the

Financials Console. The ability to modify the SOC box is available only for users with the Subject SOC privilege.

SOC Modifier:

The SOC (standard of care) modifier is used to indicate if the standard of care procedure is Q1, Q0 or U (unknown). This field is used in conjunction with the Financials

Console, where the procedure is specified to be Q1, Q0 or U for the study, on a visit basis. The ability to modify the SOC modifier is available only for users with the

Subject SOC privilege.

Missed/Missed Count:

Check the Missed checkbox if the procedure was missed during the visit. When the procedure is scheduled for multiple times on the visit date and some of the procedures are missed, enter the number of missed instances of the procedure in the Missed Count field. Entering data here results in a visit variation in the Financials Console.

N/A:

Check the N/A (not applicable) checkbox if the procedure does not apply for this visit. An N/A procedure results in a visit variation in the Financials Console.

Location:

When the procedure can be performed at different clinic locations (Cost Centers) and that location (Cost Center) is defined in the Financials Console, the location for this visit can be selected from the list. If the Cost Center functionality is not enabled, this column will not display.

Additional Procedures:

To record additional procedures for a visit, click the [Additional Procedures] button. (The button will appear only after the visit has been marked as Occurred.) A popup window will display.

Additional Procedures Browse Box: file:///C:/Users/leya/Downloads/Subject%20Visit%20Tracking%20and%20Forms%20-%20OnCore%20Documentation.htm

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The Protocol Procedures tab shows all procedures already assigned to the protocol. Any associated forms will be listed as well.

The All Charge Master Procedures/Labs tab shows all labs, panels, and procedures defined in the Charge Master.

The Filtered Charge Master Procedures/Labs tab shows Charge Master labs, panels, and procedures grouped by Filter Name (as defined in the Charge Master).

The Search tab allows you to search for labs, panels, and procedures defined in the Charge Master. On each tab, use the checkboxes and the [Submit] button to select an additional procedure for the visit. Adding an additional procedure will result in a deviation in the Financials Console.

Billing Slip

A [Billing Slip] button is available for generating a PDF file with information about the subject visit and procedures.

Additional Visits

At times, subjects will be seen for visits that are not on the standard schedule. These visits can be recorded via the Additional Visits tab. Clicking the [New] button on the

Additional Visits tab displays a Subject Visit Update page where visit details can be entered.

Once a Visit Date is entered and the [Submit] button clicked, an [Additional Procedures] button displays at the bottom of the page. Only procedures selected from the

Protocol Procedures tab have the ability to have Forms associated with them. When the forms are displayed on the Forms by Status > To Do Forms tab, the visit will be named ‘Additional’.

Additional visits do not appear on the subject calendar. Additional visits cannot be deleted once placed on an invoice, even if that invoice has been voided.

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Subject Forms

Subject Visit Tracking and Forms - OnCore Documentation

OnCore calendars define subject visits with procedures and associated CRFs (case report forms). Within OnCore documentation, the term forms is used to refer to CRFs.

To Do Forms

When a subject visit has been marked as Occurred, OnCore uses the visit’s scheduled procedures to determine which forms need to be filled out. OnCore provides an easy way for you to see the list of forms that need to be completed.

In the Subject Console, forms that need to be completed are listed on the Forms by Status > To Do Forms tab.

Subject Console > Forms by Status > To Do Forms tab (after an occurred visit):

Forms do not appear on this page if the procedure they are associated with has been marked as Missed on the Subject Visit Update page.

Click the link in the Form No. column to activate and view the form. Below is a Previous and Concomitant Medications form.

Previous and Concomitant Medications Form; Edit General Form Data: file:///C:/Users/leya/Downloads/Subject%20Visit%20Tracking%20and%20Forms%20-%20OnCore%20Documentation.htm

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Form Summary

The table at the top of the form contains the following fields, regardless of the form type and the procedure.

Category

Displays the form category defined in the eCRFs/Calendars > Forms. This field cannot be edited.

Data Entry Begin Date

This field is automatically populated with the date that the form moved from To Do status to Active status, and cannot be edited. The only way to change this date is to delete an active form, which returns it to To Do status.

Visit Date

The Visit Date populates from the Visit Date in the Subject Visit Update page. The date can be changed, but the change does not propagate to the subject Visit

Date field.

Missed

Check the checkbox if the form is not filled out.

Not Applicable

Check the checkbox if this form is not required (for example, when a pregnancy test is included for a male subject’s visit).

Lab

The lab performing the evaluation is selected from the Lab browse button.

Edit/Save/Cancel

Click Edit to enter or modify data in the header. While in edit mode, the Save and Cancel links are available, and apply to data entered in the header only.

Form Data Entry

The fields on the bottom portion of the page are specific to each form, and are used to record the data from the visit procedure. Required fields are shown with a red asterisk.

[Apply]

This button is included in multirow grid sections to allow multiple rows to be entered before saving. Note that applied changes are not saved until the [Save] button is clicked. Any changes added to a multirow grid section must be applied before clicking [Save]; otherwise, a warning message will display that unapplied changes will be lost.

[Save]

Saves the data on the form. Any data entered within a multirow grid section must be applied before saving.

Form Notes and Queries

Notes can be added for the entire form, for each row of saved data, or for an individual field.

To add a note relevant to the entire form, click  tab permits the entry of any number of form-level notes.

. The resulting popup window contains two tabs: one for notes and one for query responses. The Notes

Clicking on the Queries tab displays a place to enter responses to any form-level queries.

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Notes and query responses can also be added for each line of saved subject data, by clicking the blue notes button or orange query button associated with the line. To add a note specific to an individual field, first save the data, then hover over the field until the blue notes icon appears.

Keep in mind that Notes cannot be deleted once they have been saved.

Active Forms

When a form has been selected from the list displayed on the To Do Forms tab, the form is given a status of 'Started'. Started forms are shown on the Forms by Status >

Active Forms tab.

Subject Console > Forms by Status > Active Forms tab:

While in the Active Forms tab, you are able to use the Form No. link to open the form for editing. The form will remain as an Active Form until you declare the form to be complete by clicking the Complete link on the form. (See the screenshot below.)

Subject Console > Forms by Status > Active Form View: file:///C:/Users/leya/Downloads/Subject%20Visit%20Tracking%20and%20Forms%20-%20OnCore%20Documentation.htm

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In declaring a form as complete, you are stating that the form is completely filled-out and is ready for a data monitor to validate the data. Once the form is Complete, the form displays on the Completed Forms tab.

Completed Forms

Once the form is declared Complete, it displays on the Forms by Status > Completed Forms tab.

Subject Console > Forms by Status > Completed Forms tab:

Even though the form has a status of Completed, you are able to use the Form No. link to open the form for editing.

Planned Forms

When a visit has a planned date in the past and remains unverified, its forms are shown on the Forms by Status > Planned Forms tab.

Forms Summary

The Forms by Status > Forms Summary tab displays two tables tallying the subject’s forms by status.

Subject Console, Forms by Status, Forms Summary:

Forms By Visit

The Forms By Visit tab displays subject forms for a single visit or all visits, depending upon the selection in the drop-down field at the upper right of the page. Selecting All displays every form from every verified visit. Once a visit is marked as Occurred, it will become a selection in the drop-down field.

When forms are displayed, you can click a form link to begin or continue entering data into the form.

Subject Console, Forms By Visit tab: file:///C:/Users/leya/Downloads/Subject%20Visit%20Tracking%20and%20Forms%20-%20OnCore%20Documentation.htm

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Retrieved from "http://docs.onsemble.net/index.php?title= Subject_Visit_Tracking_and_Forms&oldid= 18348" file:///C:/Users/leya/Downloads/Subject%20Visit%20Tracking%20and%20Forms%20-%20OnCore%20Documentation.htm

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Online Forms Monitoring Overview - DM Console

Alternate Versions

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Page Contents

1 DM Console

1.1 Accrual

1.2 Forms By Status

1.2.1 Forms Summary

1.2.2 Form Status Tabs

1.2.3 Amended Forms

1.2.4 Validated Forms

1.2.5 Locked Forms

1.3 Protocol Calendar

1.4 Data Export

2 Validation Process

2.1 Validating a Form

2.2 Locking a Form

3 Query Process

3.1 Querying a Form

3.2 Queried Forms

3.3 Responding to a Queried Form

DM Console

This product overview covers the entire DM Console. Note that this overview will eventually be replaced by a set of wiki pages that correspond one-to-one with the pages in the DM Console.

The DM (Data Monitor) Console is the validation and management workspace for online forms. As online forms are declared as Completed, the data monitor is able to validate the data and either raise a query or lock the form.

Raising a query sends the form and a question back to the person who entered the data. A queried form can be amended and then validated and locked. The process of querying and amending a form may have multiple iterations.

Locking a form is intended to preserve the form data. (Centers determine what the locked status represents to them. For example, a locked form may mean that no changes are allowed after the form reaches the locked status.)

The DM Console is displayed by selecting the eCRFs/Calendars > DM Console menu item. Once displayed, a protocol must be selected in the Select Protocol field.

Accrual

After launching the DM Console and selecting a protocol, the Accrual tab is displayed.

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Summary information about the protocol’s subjects is displayed in the upper portion of the page. Accrual details by subject are seen in the lower portion of the page.

A View PDF link at the lower right will generate a PDF document with the page header and accrual data.

Forms By Status

Each subject form may be assigned one of the following statuses:

To Do

Assigned to forms for a subject visit marked as Occurred. This status will remain until form data entry begins.

Started

Assigned to a form when the data entry process is started. This status is set the first time the form is accessed.

Completed

Assigned when the form is declared as Completed.

Queried

Assigned when the Data Monitor adds a note questioning the form data. The CRA is expected to respond.

Amended

Assigned when the CRA responds to a Queried form. The response is sent to the Data Monitor.

Missed

Assigned to a form that has been marked as Missed or occurs on a visit or procedure that was marked as Missed.

Additional

Assigned to an additional form instance created for a subject’s visit.

Validated

Assigned when a Data Monitor declares the form data is valid. Validated forms are not editable.

Locked

Assigned when a Data Monitor locks the form, declaring the form data as unchangeable. A special security privilege is required to undo this status.

N/A

Assigned to a form that has been marked as Not Applicable or occurs on a visit or procedure that was marked as Not Applicable.

Forms Summary

On the Forms by Status tab, the Forms Summary horizontal tab identifies how many forms are in each status across the protocol (upper table) or by individual subject (lower table).

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Form Status Tabs

A data monitor’s role begins once a form is declared Completed. The monitor may query the form (placing it in Queried status), receive a query response (Amended status), validate the form (Validated status), or lock the form (Locked status). The Forms by Status tab contains horizontal tabs to display forms having these statuses.

DM Console > Forms by Status: 

Clicking on a column heading will sort the forms information by the specified column. A primary sort (left click) and a secondary sort (right click) are available. Use the

Save Sort Preferences link at the bottom right to reuse these settings the next time the tab is displayed (Each tab may have its own sort preference).

When using the horizontal tabs, use the Filter Forms By Subject drop-down (found in a vertical tab) to limit the display to forms for a specific subject.

Displaying Forms

When viewing entries in the Forms By Status horizontal tabs, clicking a link in the Form No. column will display the form and its data. Note the form status at the upper right of the form display.

Subject Form: file:///C:/Users/leya/Downloads/Online%20Forms%20Monitoring%20Overview%20-%20DM%20Console%20-%20OnCore%20Documentation.htm

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The top vertical tab displays the form number.

Directly below is the name of the DM Console horizontal tab containing this form. Clicking it will return you to the DM Console, redisplaying the horizontal tab.

Next Form and Prev Form tabs may be used to display other forms listed in the DM Console horizontal tab (i.e. having this status).

After reviewing the form data, the Data Monitor can validate or query the form (discussed below).

Status History

The Status History link displays the history of the form: when data entry was started, when the form was declared complete, when the form was queried, amended, etc.

Change History

The Change History link displays the change history of the form. When the value of an exam is changed, the Change History will show the original value entered (Old

Value) and the New Value entered along with the user and the date.

Amended Forms

All forms with the status of Amended appear on the Amended Forms horizontal tab. Displaying an amended form allows you to review a query response, raise another query, or change the status to Validated.

Validated Forms

Forms with the status of Validated appear on the Validated Forms horizontal tab. The forms can be individually updated to the Locked status by clicking on the form link or the  Lock Selected Forms  button can be used to lock all selected forms within the Validated tab.

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Online Forms Monitoring Overview - DM Console - OnCore Documentation

Locked Forms

All forms with the status of Locked appear on the Locked Forms horizontal tab. The forms can be individually unlocked by clicking on the form link and clicking the 

Undo Locked  button. This will change the form status back to Validated. (Only users with the appropriate privilege will see the  Undo Locked  button.)

Protocol Calendar

From the Protocol Calendar tab in the DM Console, the protocol calendar is visible. Changes to the protocol calendar are not allowed from the DM Console.

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Data Export

The DM Console > Data Export tab allows you to export all form data for a protocol. The data will export onto a single spreadsheet. When the form status filter is used, only forms with the status selected (All, Completed, Validated) will be exported.

To limit the data exported to a single subject, select the subject in the Filter Forms By Subject box before clicking the  Export  button.

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Lab Exams as Columns

Select the checkbox to see lab items presented in columns rather than rows within the export. This option will automatically present the values from the second column on the form underneath the lab item names.

Use Domain Descriptions

Select the checkbox to include option list descriptions rather than numeric codes in the export.

Validation Process

The DM Console validation process is straightforward: display a completed form, review the data, declare the form as validated, then declare the form as locked.

Validating a Form

In the Forms By Status horizontal tabs, clicking a link in the Form No. column will display the form and its data. If the data is accurate and the monitor has no questions, the form can be Validated by clicking the  Validate  button (shown for Completed and Amended forms).

DM Console > Validate:

This will disable the form’s data entry capability on the CRA Console and the Subject Console, and set the form status to Validated.

DM Console > Validated Status: file:///C:/Users/leya/Downloads/Online%20Forms%20Monitoring%20Overview%20-%20DM%20Console%20-%20OnCore%20Documentation.htm

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When a form is Validated, an  Undo Validated  button will appear. Clicking the button will return the form to the Completed status.

Locking a Form

A Validated form can be Locked by clicking the  Lock  button. Locking a form prevents editing of form data.

DM Console > Locked Status: file:///C:/Users/leya/Downloads/Online%20Forms%20Monitoring%20Overview%20-%20DM%20Console%20-%20OnCore%20Documentation.htm

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When a form is Locked, an  Undo Locked  button will appear. (A separate security privilege is required for this button to display.) Clicking the button will return the form to the Validated status.  

Query Process

On the Forms By Status tab, Completed or Amended forms are listed. Clicking a form’s link in the Form No. column displays the form. If the Data Monitor has a question or concern about the form data, the form can be Queried.

Querying a Form

For example, if the value for Creatinine raises a flag to the Data Monitor, she can use the DM Console to send a query to the CRA who entered the data into the form.

The first step is to hover over the field name and click the  +Query  button, which will launch a pop-up window where the Data Monitor can enter a query.

DM Console, Notes Browse:

After entering the query, clicking the  Save  button, and clicking  Close , the form appears again. The Creatinine field now includes a question mark icon indicating there is a query along with a count of the number of outstanding queries/the total number of queries. The link may be clicked again to enter another query.

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After entering all queries, the Data Monitor must click the  Query  button. This will change the status of the form to Queried and will send the queried form to the CRA who entered the data. In addition, the  Undo Queried  button is available.

Queried Forms

From the Queried Forms tab of the DM Console all forms with the status of Queried are displayed. The form will remain visible from the queried tab until the status of the form is changed to Amended by the CRA.

Clicking the form link displays the form, and clicking the question mark icon launches a pop-up window that displays the query.

If needed, the Data Monitor can undo the queried status of a form. To do that, the Data Monitor should mark the queries as closed by clicking the Close link and clicking the

Submit  button.

Subject Form Query Browse:

After closing the queries, the DM must click the  Undo Queried  button on the form display page. This will undo the Queried status and mark the form as Completed.  

Responding to a Queried Form

A queried form is a form that requires attention from the CRA – a question has been raised and clarification is required. To bring a queried form to the attention of the CRA, the CRA Console Forms by Status tab is highlighted as shown in the following screenshot.

CRA Console: Vertical Tab Selection:

Click the CRA Console > Forms By Status > Queried Forms tab to see the queried forms for the selected protocol.

CRA Console, Queried Forms: file:///C:/Users/leya/Downloads/Online%20Forms%20Monitoring%20Overview%20-%20DM%20Console%20-%20OnCore%20Documentation.htm

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All Queried forms for the protocol are displayed. Clicking the Form No. link will open the queried form so you can see and respond to the query.

CRA Console, Subject Form:

The question mark icon provides a visual indicator that the row has queries. A number shows how many queries don’t have responses. Clicking the question mark icon allows the CRA to read the query and enter a response.

CRA Console, Query Response: file:///C:/Users/leya/Downloads/Online%20Forms%20Monitoring%20Overview%20-%20DM%20Console%20-%20OnCore%20Documentation.htm

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If data needs to changed, this must be done from the Subject Form page. When editing a Completed or Queried form, a pop-up will appear requesting the reason for the change.

Reason for Change:

Once the value has been updated and a response has been saved for all queries, the CRA can change the form status from Queried to Amended by clicking the Respond link.

(If there are multiple queries, the Respond link will only appear after all queries have been addressed.)

CRA Console, Queried Forms, Respond:  file:///C:/Users/leya/Downloads/Online%20Forms%20Monitoring%20Overview%20-%20DM%20Console%20-%20OnCore%20Documentation.htm

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Changing the status to Amended makes the form available to the Data Monitor from the DM Console as an Amended form.

Note that the query/amend process is iterative and allows the form to circle between Queried and Amended multiple times until an acceptable resolution is reached.

Retrieved from "http://docs.onsemble.net/index.php?title= Online_Forms_Monitoring_Overview_-_DM_Console&oldid= 14184" file:///C:/Users/leya/Downloads/Online%20Forms%20Monitoring%20Overview%20-%20DM%20Console%20-%20OnCore%20Documentation.htm

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Biostat Console Overview

Biostat Console Overview - OnCore Documentation

Alternate Versions

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Page Contents

1 Biostat Console

1.1 Getting Started

1.2 Accrual

1.3 Forms

1.4 Exporting Data

1.5 Protocol Calendar Information

Biostat Console

This product overview covers the entire Biostat Console. Note that this overview will eventually be replaced by a set of wiki pages that correspond one-to-one with the pages in the Biostat Console.

OnCore’s Biostat Console is used to extract data from OnCore for use in statistical analysis tools. The Biostat Console can also be used to view the current progress of protocols related to accruals, forms, and adverse events.

Getting Started

To access the Biostat Console, select the eCRFs/Calendars menu, then the Biostat menu item.

From the initial Biostat Console page, you can select a protocol by entering the protocol number in the Select Protocol field.

eCRFs/Calendars > Biostat Console > Select Protocol search field:

Accrual

The Accrual tab is divided into an upper and lower section. In the upper section of the page the Accrual Summary table shows a summarized view of accrual information for the protocol. Detailed accrual information is displayed in the Accrual Details table shown in the lower section of the page.

eCRFs/Calendars > Biostat Console > Accrual tab: file:///C:/Users/leya/Downloads/Biostat%20Console%20Overview%20-%20OnCore%20Documentation.htm

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The Accrual Summary table shows the number of subjects who have signed at least one consent form, as well as the number of subjects currently on study, off treatment, off study, or expired.

eCRFs/Calendars > Biostat Console > Accrual tab > Accrual Summary section

The Accrual Details table shows accrual information for each subject on the protocol. The following fields are displayed.

Subject MRN

Last Name

First Name

Arm the Subject’s MRN (when you have access to see it) the first name of the subject (when you have access to see it) the first name of the subject (when you have access to see it) the specific Arm to which the subject is assigned

Level

Study Site

Sequence No.

the specific Level for the subject the site to which the Subject has been accrued the Sequence Number assigned to the subject (if you don’t have identifier access)

Consent Signed Date the date the initial Consent Form was signed

On Study Date the date the subject went On Study

On Treatment Date the date the subject went On Treatment

Off Treatment Date the date the subject went Off Treatment

Expired Date the date the subject expired eCRFs/Calendars > Biostat Console > Accrual tab > Accrual Details section:

The column headers are links used to sort the table rows based upon the column data.

You may print the Accrual Details by using the View PDF link at the bottom of the page to generate a PDF version of the table.

Forms

Forms Summary

On the Forms tab, the Forms Summary horizontal tab displays an overview of forms and their statuses for the selected protocol. Here are the statuses.

Queried any form on which the data monitor has questioned data, CRA to address question and respond

To Do any form for which the subject’s visit is verified and online forms for the visit are available

Started any form on which the data entry process is started (subject visit activated in Subject Console)

Completed any form on which data entry is finished and form is declared as completed

Amended any Queried form which the CRA has answered and sent a response to the data monitor

Missed

N/A any form which has been declared as Missed any form which has been indicated as Not Applicable

Additional any form which has had an additional form instance created for a subject’s visit

Validated any form on which the data monitor has declared the form data as valid

Locked any form on which the data monitor has declared the form data as unchangeable

Planned any form for a visit not checked in where the planned visit date has passed

The page is divided into two sections. The top section shows summary information for all forms.

eCRFs/Calendars > Biostat Console > Forms Summary tab > Forms Summary section file:///C:/Users/leya/Downloads/Biostat%20Console%20Overview%20-%20OnCore%20Documentation.htm

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The Subject Forms Summary table shows the number of forms in each status for each subject accrued to the protocol.

Missing Forms

On the Forms tab, the Missing Forms horizontal tab displays all forms which have been missed for the protocol. This is calculated by counting the forms that have been marked as Missed or Not Applicable for each subject accrued to the selected protocol. (For more information, see the Subject Visit Tracking and Forms overview.) eCRFs/Calendars > Biostat Console > Missing Forms tab

To generate a PDF version of the table, click the  View PDF  button.

Additional Forms

On the Forms tab, the Additional Forms horizontal tab displays the additional forms created for subject visits. Additional forms result by selecting Additional Procedures on the Subject Visit Update page or from the Additional Forms tab in the Subject Form Update page. (For more information, see the Subject Visit Tracking and Forms overview.) eCRFs/Calendars > Biostat Console > Additional Forms tab:

The SAE Counts tab displays serious adverse event information for a protocol. This information is displayed per Treatment Arm. Adverse event types are shown in the AE

Details column of the table, and various grades are broken out into specific columns.

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By default, all adverse events are included. You may use the Sources and Attributions multi select fields to filter the data to those AE Details that match the selected sources and attributions. Use these fields and click  Submit  to display matching adverse event data. The  Reset  button returns the sources and attributions to their default setting, in which all are selected.

Click  View PDF  to generate a PDF version of the adverse event information table.

Exporting Data

The Data Export tab is used to collect data for use in statistical research efforts. From the Data Export page you can select data to be exported into Excel spreadsheets or files formatted for easier import into SAS.

By default, the Export Data page initially displays information for any form, in all categories and all states, as indicated by the Form Status field at the upper right of the page (see the screenshot below). Through the Form Status field you can filter the Non-Empty Forms display count to only show Completed or Validated forms. Regardless of the selection for the Form Status field, the export process will export all available forms.

The Export? column checkboxes are used to select what forms will have data exported. You may also click the All, Non-Empty, or None links displayed below the form rows to select forms for export.

eCRFs/Calendars > Biostat Console > Data Export tab:

At the bottom of the form listing are checkboxes that affect the output of the data that is exported, and can be useful to make the exported data files easier to use in other data analyzing systems.

file:///C:/Users/leya/Downloads/Biostat%20Console%20Overview%20-%20OnCore%20Documentation.htm

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The Lab Exams as Columns checkbox allows you to display each lab exam as a distinct column in the export.

The Use Descriptions checkbox determines if Code values or Description values are displayed in the export.

The Exclude Headers checkbox controls if column headers are included in the output to Excel or not.

The Use Internal Column Names checkbox controls whether the internal name for the form field will be used as the column header in the SAS export file (the checkbox will be checked by default when the Export Format is changed to SAS).

The Include Rows for Empty Forms checkbox determines if empty forms are included in the output. This allows you to see whether the form was missed or there were no data to enter into the form.

Once the appropriate forms have been selected and the display options have been determined, you can use the Export Format field to select either SAS or Excel as the format in which to export the data.

Excel exports will be put into a ZIP file for download. Each form will be exported as a workbook with three worksheets. The first worksheet will consist of the Form data, the second worksheet will contain the Domain data, and the third worksheet will contain Format information for the data fields included on the form. If only one form is exported, the export file will not be zipped.

Forms exported in SAS format will be sent to a ZIP file with each form in a separate folder. Each form’s folder will contain four files: one with form data, one with a

SAS/OnCore field name map, one with the domain data, and one with format information. These data can then be imported into SAS as well as used by other statistical software such as R. When the forms are exported in SAS the data are formatted as simple text with the fields delimited by tabs.

Depending upon the format of your eCRF, the export may create multiple files. For example, multiple files will be created when the eCRF contains two grid sections, but a single file will be created when the form contains only a list section and a grid section.

Regardless of the export format chosen, a progress dialog box is displayed. This progress dialog includes a  Cancel  button which you can use to cancel the export, as shown in the following screenshot. Once the export is complete, the file download will automatically appear.

Export Progress Dialog

In the Export File, Sequence Number, Initials, Form, Not Applicable, Phase, Segment, Cycle, Day, Visit Date, Form Status, Arm, and Level will all be standard columns.

Following those fields the Form data will display.

If the form has date fields, there will be an additional column for each date field with an EXT suffix on the column name. Forms exported from the Biostat Console with

Fuzzy dates will display as 01/01/YYYY with 'Year' in the dates's EXT column when the date is accurate to the year. Dates accurate to the month will display as

MM/01/YYYY with 'Month' in the date's EXT column. Dates that are NOT fuzzy dates will display how they were entered with the exact day, month, and year.

The Follow-up and Demographics forms contain data from the Follow-Up and Demographics tabs in the Subject Console and do not contain any form data. The number of

Non-Empty Forms for Follow-Up is equal to the number of subjects with an On Study Date whose current status is Off Treatment or On Follow Up. The number of Non-

Empty Forms for Demographics is equal to the number of subjects with an On Study Date.

If a form contains a field using the Toxicity domain, the export automatically includes a column for AE Category.

Protocol Calendar Information

The Protocol Calendar tab is designed to be used as an easy reference tool to allow you to see the Calendar and Forms for a protocol. From the Protocol Calendar page, you can choose to export the calendar to Excel via the View Excel button, or view the forms as a PDF via the PDF Forms button.

From the Protocol Calendar page, you can choose to show or hide the selected lab/panel items (e.g. Under Blood Chemistries, the Albumin, BUN, Creatinine values) in the calendar by using the Show Items and Hide Items hyperlinks at the top of the calendar.

eCRFs/Calendars > Biostat Console > Protocol Calendar page file:///C:/Users/leya/Downloads/Biostat%20Console%20Overview%20-%20OnCore%20Documentation.htm

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Post-Award Financials:

Invoicing and Receipts

During the budgeting process in OnCore, financial staff enter the cost of each invoiceable subject milestone, as well as any protocol-related costs (such as IRB review fees) and pass thru items (MRI, CT scans, etc.,) which can be billed to the sponsor.

Any of the budgeted milestone costs, protocol-related costs, or pass thru items can be added to a sponsor invoice in OnCore. Invoices can be printed and mailed to the study sponsor, or the financials team might simply use the invoices to reconcile the study-related costs incurred with sponsor payments received.

In this section, you will enter subject statuses and visit details to trigger invoiceable items and complete the post-award tasks in the Financials Console.

Post-Award Financials | Page 1 of 14

Entering Subject Data and Tracking Visits

Costs entered in the Financials Console > Milestones tab cannot be added to an invoice until they occur and are recorded in OnCore. Invoices can be adjusted for missed visits, missed procedures, unscheduled visits or additional procedures that are needed—anything that does not happen exactly according to the schedule of events in the clinical calendar is recorded as a visit variation.

Invoiceable items and visit variations can be generated when:

 Subject visits are checked in (marked as Occurred)

 Subject visits are marked as Missed

 Additional procedures are performed during a subject visit

 Additional (unscheduled) subject visits occur

 Subject statuses are achieved (e.g., a subject reaches a status of On Study)

 Subject events are recorded (OSRs, SAEs, or screen failures)

 IRB reviews are documented for a protocol

 Pass thru procedures are performed during a subject visit (MRI, CT scan, and so on)

Enroll a subject on a protocol

Typically, subject visits and milestones can be invoiced to the sponsor as soon as they are checked in (marked as Occurred) by the study team. Study team members

(clinical research associates, research nurses, and so on) use the CRA Console and Subject Console to document subject information and track subject visits.

1.

Navigate to

Subjects > CRA Console.

2.

If necessary, select your protocol from the Select Protocol field. The protocol status must be OPEN TO ACCRUAL.

Visit the OnCore Learning Portal at http://docs.onsemble.net

Post-Award Financials | Page 2 of 14

The CRA Console provides a summary of all subjects who have registered to this protocol and their most recent status (CONSENTED, ELIGIBLE, ON

TREATMENT, and so on). If no subjects have been registered to a protocol yet, the CRA Console will be blank.

3.

Click New Subject Registration.

4.

In the Study Site field, select Outstanding Research Center. This is the study site to which the subject will be enrolled.

5.

Enter all required subject information (indicated by an asterisk *), then click

Add.

Subject MRN: XYZ55024 (where XYZ is your initials)

Last Name: any value

First Name: any value

Birth Date: y-38

Gender: any

Ethnicity: any

Race: any

The Subject Console opens, where details about each subject are tracked.

The information entered during registration appears in the Demographics tab.

Post-Award Financials | Page 3 of 14

Document a subject’s consent

1.

Navigate to Subject Console > Consent.

2.

Enter a Signed Date of m-5, and then click Select Consents.

3.

In the Status field, select Accepted, then click Save.

Note that the subject status in the header changes to CONSENTED.

Document a subject’s eligibility status

1.

Click Eligibility.

2.

Type your name in the Verified By field.

3.

Enter a Status Date of m-5.

4.

Complete the Eligibility questionnaire by selecting the green (eligible) answer for each question, then click Submit.

Note that the subject status in the header changes to ELIGIBLE.

Document subject statuses (On Study and On Treatment)

1.

Navigate to Subject Console > On Study.

2.

Enter a Sequence No. if the field is available, and an On Study Date of m-5.

NOTE: If the Sequence No. field is not editable, a sequence number will be automatically generated for this subject.

3.

Click Submit.

The subject status in the header changes to ON STUDY.

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Post-Award Financials | Page 4 of 14

6.

Click Treatment, then click Add.

7.

Choose any available Arm.

8.

Enter an On Arm Date of w-20 and an On Treatment Date of w-20.

9.

Click Save.

The subject status in the header changes to ON TREATMENT.

These subject dates created visits on the subject calendar to be available for check-in. When these visits are marked as occurred or missed, invoiceable items will appear in the Financials Console and can be added to a sponsor invoice.

Mark subject visits as occurred

1.

In the Subject Console, click Calendar.

2.

Click Screening to open the screening visit details page.

3.

In the Visit Status section, select Occurred, then click Submit and Close.

This visit has been checked in. If it was selected as a billable subject milestone in the Milestones tab of the Financials Console, it will now appear in the

Invoiceable Items tab for billing.

Indicate that a procedure was missed or N/A

1.

In the Calendar tab, click C1D1. In the Visit Status section, click Occurred.

2.

Select the Missed checkbox for the Complete Metabolic Panel (A).

3.

Enter low blood collection volume in the Reason for Change field, and then click OK.

Post-Award Financials | Page 5 of 14

4.

Click Submit and Close.

This visit has been checked in, but because the Complete Metabolic Panel was not performed, a visit variation will appear in the Financials Console, which can be added to an invoice and credited back to the sponsor, if appropriate. The visit will still appear in the Invoiceable Items tab.

Mark subject visits as missed

1.

In the Calendar tab, click the C1D15 visit.

2.

In the Visit Status section, select Missed, and then click Submit and Close.

This entire visit has been marked as Missed. It will not appear as an

Invoiceable Item in the Financials Console, but a visit variation was created and can be added to an invoice and credited to the sponsor, if appropriate.

NOTE: Most likely, you will simply refrain from invoicing the sponsor for missed visits. But if the billable milestones for this protocol are subject status milestones (for example, subjects who achieve a status of On Treatment) then it might be appropriate to credit the sponsor for a missed visit.

Indicate that additional procedures were performed

1.

In the Calendar tab, click the C2D1 visit.

2.

In the Visit Status section, select Occurred, and then click Submit.

The visit is checked in, but the Subject Visit Update page is still open.

3.

Click Additional Procedures at the bottom of the page.

4.

Select the checkbox to add an unscheduled Physical Exam to this visit.

5.

Click Submit.

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Post-Award Financials | Page 6 of 14

6.

In the Reason for adding field, type Subject presented with severe

abdominal pain, and then click OK.

7.

Click Submit and Close.

This visit is checked in and will appear in the Invoiceable Items tab of the

Financials Console. A visit variation for the unplanned Physical Exam will also appear in the Financials Console and can be added to a sponsor invoice.

Indicate which procedure alternative was performed

1.

In the Calendar tab, click the C2D15 visit.

2.

In the Visit Status section, click Occurred.

3.

Select the Imaging procedure that was performed.

4.

Select MRI – with dye.

5.

Click Submit.

This visit was selected as a billable milestone for this protocol, so it will appear in the Invoiceable Items tab of the Financials Console. The MRI imaging procedure will also appear in the Invoiceable Items tab because it has a charge type of Pass Thru, so it can be added to an invoice and will appear as its own line item.

Generate a billing slip

The billing slip is a list of procedures performed during a subject visit. The billing slip might include all procedures performed, or it might only list the procedures that were performed by non-research staff. The hospital billing team might request a billing slip so that those subject procedures can be charged to the appropriate account(s).

1.

On the Subject Visit Details page, click Billing Slip.

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A PDF document is generated in a new browser tab or window.

2.

Click Submit and Close.

Document a subject SAE (serious adverse event)

Screen failures, SAEs, and OSRs can be invoiced to the sponsor if they are selected in the Milestones tab of the Financials Console and a negotiated cost is entered. Screen failures and SAEs are tracked in the Subject Console.

1.

Navigate to Subject Console > SAEs.

2.

Click New.

3.

Enter the required information for this serious adverse event, as well as any other appropriate details:

Event Date: w-2

Reported Date: t

Reported By: [your name]

Outcome: Recovering/Resolving

Event Narrative: Patient received severe burns on upper arm and face during family BBQ; hospitalized for 24 hours

Protocol Attribution: Unrelated

4.

Click Submit.

Remember that this sponsor agreed to pay for the 6 th

SAE documented for subjects on this study. The first five SAEs will not appear on the Invoiceable

Items tab of the Financials Console, but the 6 th

SAE (and each one after that) will appear.

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Post-Award Financials | Page 8 of 14

Creating Sponsor Invoices

All subject events (visits, subject statuses, SAEs, OSR, and/or screen failures) selected on the Milestones tab of the Financials Console appear in the Invoiceable

Items tab and can be added to a sponsor invoice. Protocol related events (IRB review fees, pharmacy fees) and Pass Thru events (expensive items such as MRIs or CT Scans) can also be added to sponsor invoices.

Once an invoice is generated, the total amount can be adjusted by adding visit variations (any procedures or visits that were unplanned or missed) and either adding or crediting back charges appropriately.

Add protocol-related events to an invoice

1.

Navigate to Financials > Financials Console > Invoiceable Items. Open your protocol by selecting it from the Select Protocol field.

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1.

In the Protocol Items section, select the following items to add to an invoice:

 Select the checkbox for

IRB Initial Submission

 Select the checkbox for Quarterly Pharmacy Fee

NOTE: Remember that the IRB Initial Submission is not a variable protocolrelated event. It can only be invoiced once during this entire study.

If you only want to add protocol items to this invoice, click Create Invoice.

Otherwise, you can continue to select items that should be included on this invoice.

IMPORTANT

Do not enter an Invoice Date until this invoice is complete. Invoices with an

Invoice Date cannot be edited; they can only be voided or amended..

Add subject-related milestones to an invoice

1.

In the Subject Milestone Items section, select the checkboxes for all occurred visits (visits with an Occurred Date).

Add pass thru procedures to an invoice

1.

In the Pass Thru Items section, select the MRI – with dye checkbox to add it to an invoice.

Good to know

2.

Click Create Invoice.

An invoice is created with all selected items. This invoice remains editable

(additional items can be added, visit variations can be added, and so forth) until an Invoice Date is entered.

Only the costs of Subject

Milestone Items are not editable on an invoice.

The costs of Protocol Items,

Pass Thru Items and Visit

Variations can be manually adjusted on the invoice, if necessary.

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Post-Award Financials | Page 10 of 14

Note that the Remit To address from the Parameters tab appears on the invoice automatically.

3.

In the Bill To section, click Select.

4.

Select the checkbox for the Payor, and then click Submit.

Add Visit Variations to an invoice

1.

Click Visit Variations.

2.

Use the Select? checkboxes to include additional or missed procedures or visits on this invoice.

 From the C1D1 visit, select the missed Complete Metabolic Panel

 From the C2D1 visit, select the additional Physical Exam

3.

Click Submit.

The sponsor is credited back the amount for the missed panel, and the cost of the additional physical exam is added to the invoice total.

Finalize an invoice

To finalize this invoice, you need to enter an Invoice Date.

1.

Enter t in the Invoice Date field and click Submit.

The Update button no longer appears on this invoice. The only available options are Void and Amend.

Amending or voiding an invoice

Voiding an invoice will release its invoiceable items and visit variations so that they can be added to another invoice in the future.

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Amending an invoice will quickly void the current invoice and create a new, identical invoice that does not have an Invoice Date entered. This new invoice is editable.

View invoice withholdings

If a withholding percentage is entered for a sponsor in the Parameters tab of the

Financials Console, a certain amount of each invoice will remain unpaid until study closure.

1.

Navigate to Financials Console > Invoices.

2.

Click the Invoice Withholdings horizontal tab.

All invoices are listed, with the total amounts due and the amount due after withholding. At the end of the study, make sure that the checks received from the sponsor cover the billed amounts and the withholding amounts on each invoice.

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Post-Award Financials | Page 12 of 14

Tracking Receipts

When payments are received from a sponsor, they are tracked in the Financials

Console > Receipts tab and applied to one or more finalized invoices to determine if the sponsor has paid the full amount due at study closure.

Enter a new receipt

1.

Navigate to Financials Console > Receipts.

2.

Enter the required check details:

Sponsor: leave as default

Check No.: any number

Amount: 7500

Date Received: w-1

Date Deposited: t

Date Reconciled: t

3.

Click Add.

The receipt appears in the Payments Received table.

Apply a receipt to an invoice

1.

Next to the sponsor receipt, click Details, and then click Select.

2.

Use the Select? checkboxes to apply this receipt to one or more invoices.

Only finalized invoices (those with an Invoice Date) appear in this list.

3.

Click Submit.

4.

Type a Payment amount of 7500 to apply to each invoice.

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NOTE: The total amounts applied to each invoice cannot exceed the check amount.

5.

Click Submit, and then click Close.

Navigate to Financials Console > Invoices to view the amount paid for each invoice, as well as the outstanding balance(s) for each.

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Subject Search and Additional Consoles

Using Subject Search

Subject Search is a robust searching tool. This search option allows you to specify the search criteria and the kind of subject data to display in the search results.

Search results may be exported to a PDF report or Excel spreadsheet.

Subject Search is structured in the same way as Protocol Search, which was discussed previously.

Search for a subject

The Subject Search page provides dozens of data fields, allowing you to find one or more subjects based on a variety of search criteria. Searching for subjects is an easy process: simply enter data into fields indicating the subject data you wish to match, and then click the Search button. Add additional search values to further refine your search.

1.

Navigate to Subjects > Subject Search.

2.

In the

Last Name field, type Jones, and then click Search.

The Subject Search Results page opens. Note that the header at the top of the page lists the criteria used in the search, and the bottom of the page displays the number of subjects found.

Additional Consoles | Page 1 of 10

Navigational aids

If your search returns a large number of results, use the navigational aids displayed at the upper right of the page to display the next (or previous) page of results, or to quickly open a particular page. To further narrow the list of results, enter filter criteria in the Filter field, and press Enter.

Column headers

Below the header is a table of matching subjects, each displayed on its own row. Each of the column headers are links; clicking on a column header sorts the data in that column in ascending or descending order. Clicking again sorts the data in reverse order.

Subject MRN links

Each of the numbers in the Subject MRN column are linked; clicking a

Subject MRN link displays the subject in the Subject Console.

Buttons

The View Excel button creates an Excel spreadsheet with the search result data. The View PDF button creates a PDF document with the search results. New subject staff members are added to selected subjects by clicking the Add Staff button.

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Additional Consoles | Page 2 of 10

3.

Click Back to Search to return to the Subject Search page.

Note that the search criteria used in the last subject search remains in the search fields.

4.

Click Clear to remove the data you previously entered.

Add a search column

The Subject Search page is divided into expandable sections. Each section has a header with an [+] expand icon and a section name. To open a section, click the [+] expand icon.

1.

Click [+] to open the On Study section.

Additional search criteria specific to the On Study section appear on the page.

Listed to the left are checkboxes under the Result Column header. Selecting any of these checkboxes will include those columns on the search result page.

2.

Select the Result Column? checkbox for On Study Date. Selecting this checkbox will include this On Study Date column in the search results.

3.

In the corresponding From Date and Thru Date fields, enter an On Study Date range of 01/01/2012 to 12/31/2012.

4.

Return to the Subject Demographics section at the top of the page and select the Race checkbox.

5.

Click Search.

The Subject Search Results page opens, with the header indicating that this is a list of subjects that went On Study in 2012. Note that the On Study Date column is now included in the table of results.

6.

Click Back to Search to return to the Subject Search page.

Additional Consoles | Page 3 of 10

Saving search criteria

If you find that you run the same subject searches frequently, saving your search criteria will save you both time and effort. After you have developed and tested a commonly-used search, you may save the search to access it at a later date.

1.

Click Save As (located at the top of the page).

2.

Type a name for your search in the Name field and click Save.

NOTE: In a saved search, dates that you enter are saved as the calendar date and are not saved as a relative date. Entries like yb, for example, are not re-evaluated each time the saved search is run.

Saved searches are available in the drop-down list attached to the Saved Searches field. Saved searches also display in the Saved Searches widget on the Home screen.

Using My Console

My Console is designed to assist subject staff in managing subject visits. It provides a means to view and verify visits without accessing each subject individually from the CRA and Subject Consoles.

My Console provides a personalized view of OnCore data, displaying information that is relevant to the current OnCore user.

Explore My Console

1.

Navigate to My Console > My Console.

The My Console page contains four vertical tabs: Protocols, Subjects, Subject

Visits, and My Calendar.

My Console opens on the Protocols tab. This tab displays all protocols to which you have been assigned as part of the protocol staff, regardless of role.

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Additional Consoles | Page 4 of 10

NOTE: Protocol staff are defined on the PC Console > Main > Management tab.

A protocol must have an Active status of Open to Accrual, Closed to Accrual, or Suspended to appear in My Console. Protocols that have been Terminated or had an IRB Study Closure will not be displayed.

Each protocol has a linked protocol number displayed in the Protocol No. column. Clicking the link opens the protocol within the PC Console.

2.

Click the

Subjects tab.

The Subjects tab displays all subjects you have been assigned as part of the subject staff.

NOTE: Subject staff are defined on the Subject Console > On Study tab.

Initially, only active subjects on active protocols are displayed on the page; however, you can change this default by using the filter controls in the page header. Unselecting the Show Active Protocols Only checkbox causes all subjects from all protocols to display on the page.

You may also select a different Subject Status from the drop-down Subject

Status field, which will allow subjects of one of the following statuses to display:

Active: includes the statuses of Consented, Eligible, Eligible (O), On Study,

On Treatment, Consent Waived

On Follow Up: includes the statuses Off Treatment, On Follow Up

All: displays all subjects from all of your currently assigned protocols

Subjects display in a table with linked column headers. Clicking a column header sorts in ascending or descending order based upon data in that column.

Each subject displayed has a linked subject MRN displayed in the

Subject MRN column. Clicking the MRN link will open the Subject Console and display the selected subject.

Additional Consoles | Page 5 of 10

3.

Click the Subject Visits tab.

The Subject Visits tab contains two horizontal tabs: the Occurred Visits and

Pending Visits tabs.

Pending Visits

This tab provides a way for you to quickly update information regarding subject visits without having to navigate to each subject visit individually.

Occurred Visits

This tab allows you to see if the forms for each visit were completed, submitted, and monitored. These columns correspond to the Data

Collection Completed Date, Submitted Date, and Monitored Date fields on the Subject Visit Update page. The list is useful for keeping track of your eCRF load for externally sponsored trials if you need to complete case report forms (CRFs) and send them to the sponsor or have the sponsor monitor them.

4.

Click the Occurred Visits tab.

5.

To update the dates for these visits, select each checkbox, enter the corresponding date in the date field at the bottom of the column, and click

Submit.

NOTE: When the CRF Completed date has an entry and either the CRF

Submitted date or the CRF Monitored date also has an entry, the visit will no longer display in the list.

6.

Click the Pending Visits tab.

The Pending Visits tab allows you to view all non-occurred visits within a given timeframe. The From Date field defaults to a week prior to the current day and the Thru Date field defaults to a week after the current day. These dates quickly provide you a view of any recent visits that you still need to verify and some upcoming visits for which you may need to plan.

In addition, subject visits may be filtered by a particular protocol or a particular subject by selecting values in the Protocol Filter and Subject Filter find-as-youtype fields.

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Additional Consoles | Page 6 of 10

NOTE: If a protocol is selected in the Protocol Filter field, the Subject Filter will only supply subjects assigned to the selected protocol.

7.

In the From Date field enter 05/01/2013 and click Refresh.

The Pending Visits page displays all the pending visits for a protocol or a subject.

Visit

Each Pending Visit has a link in the Visit column. Clicking the link opens the Subject Visit Update page, where you may enter details about the visit.

Planned Visit Date

The Visit Date in the subject’s calendar.

Actual Visit Date

Making an entry in this field and clicking Submit will mark the visit as

Occurred, which you can do if you don’t have extra details to record for a visit.

Missed checkbox

You may mark a visit as Missed by selecting its checkbox and clicking the Submit button. Multiple visits may be verified simultaneously in this way. Future visits cannot be marked as Missed.

Clinical Comments

This is a read-only field, displaying the clinical comments from the

Subject Visit Update page.

8.

Click the My Calendar tab.

The My Calendar page displays your subject visits in a month-format calendar.

Initially it displays visits for subjects to whom you are assigned as subject staff, and visits for subjects on protocols to which you are assigned as protocol staff.

Good to know

The checkboxes located at the bottom of the calendar allow you to change the display defaults.

Simply unselect one or both of the Include Subject From

Assigned Protocols and Include

Assigned Subjects checkboxes.

Additional Consoles | Page 7 of 10

Modifying the Calendar view

You may change the calendar view by using the icons below the month title at the top.

Click on the icons in the middle of the header to change the calendar view to display the visits for a single day, a week, or one month. Click on the month and year in the center of the header to quickly select a new month or year from the attached dropdown list. Clicking dates located at the sides of the header allows you to page forward or backwards one month at a time.

On the calendar, the subject name, protocol number, and visit description are links that will open the Subject Console, PC Console, and Subject Visit Update page, respectively.

Using Team Console

The Team Console is a progress reporting and protocol management tool used by a management team. A staff member with a management group in their staff record will see data for all protocols assigned to the management group.

Explore Team Console

Team Console provides a personalized view of OnCore data, displaying information that is relevant to the OnCore user that is logged in to the application.

1.

Navigate to Reviews > Team Console. The Team Console specific to your management team appears.

The Management Group field is displayed at the bottom of the left column. All of your management groups are available in the drop-down list (your management groups are defined in your staff record.) Selecting a different management group

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Additional Consoles | Page 8 of 10

will update the Team Console display. Data displayed within the Team Console is relevant only to the selected management group.

NOTE: If your user account does not have at least one management group, you do not have the capability to use the console as it is meant to be used.

Pending Protocols tab

This tab displays the protocols that have yet to be opened to accrual for the selected management group. In this page you can view the protocol’s current approval status, and you review basic information regarding the protocol, such as number and title, the principal investigator, committee approvals, signoffs, and checklist items.

 The numbers in the Protocol No. column are links; clicking the on the links will open that protocol within the PC Console.

 Each protocol also displays a Checklists link; clicking this link opens that protocol within the Protocol Checklists page.

2.

Click the Open Protocols tab.

The Open Protocols tab displays protocols that are open to accrual for the selected management group. This page displays the open date, summary accrual information, and accrual information for the last four months.

NOTE: The remaining five tabs can be opened only if the Last Meeting Date field has been entered. These tabs display information that has been entered since the last meeting.

3.

Enter 01/01/2010 in the Last Meeting Date field and click the Closed

Protocols tab.

The Closed Protocols tab displays the selected management group's protocols that have been closed to accrual since the last meeting date.

Additional Consoles | Page 9 of 10

4.

Click the SAEs tab.

The SAEs tab displays the SAEs that have had an event date or reported date since the last meeting date for the selected management group. SAE information displays on the page; click the SAE link for quick access to the

SAE page.

5.

Click the Deviations tab.

This tab displays the deviations that have a reported date or deviation date since the last meeting date. Clicking the links provided allows you to quickly view the protocol and deviation information.

6.

Click the OSRs tab.

The OSRs tab displays the Outside Safety Reports that have an issued date or received date since the last meeting date for the selected management group.

This page displays information about the OSR and provides a link to open the protocol.

7.

Click the Summary tab.

The Summary tab displays the overall counts of protocols in their various statuses, along with deviation counts, OSRs, SAEs, and registrations for the selected management group.

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Additional Consoles | Page 10 of 10

What does “Financials” mean to you?

We want to use a Charge Master with standard costs to help with sponsor negotiations.

We want to document coverage analysis electronically.

We want to track negotiated costs for procedures and calculate the total cost of a subject who completes one of our studies.

We want to compare our negotiated costs with the actual costs of our protocols.

We want to invoice sponsors for visits and procedures that have occurred.

We want to reconcile payments received from sponsors, to ensure we receive all that we are owed for each protocol.

It would be helpful to know when subject visits occur and what procedures took place during that visit.

We want to send the research billing grid to our EMR, to help with charge adjudication and reconciliation.

Are you ready to start Financials?

We use OnCore to track basic protocol information, including study sponsors.

We have the required team members available for this project.

We already have clinical calendars built for our protocols.

Our study teams track subject visits, as well as missed and additional procedures.

Our end users and OnCore team have seen a demo of Financials.

For more information about starting a

Financials Implementation Project, contact the Forte Customer Engagement team: [email protected]

What are your next steps?

We need a team of calendar builders to build clinical calendars in OnCore.

We are interested in contracting with

Forte to build clinical calendars for us.

Our study teams will need to learn how to check in subject visits, mark procedures as missed, add additional procedures and visits, etc.

We need buy-in from leadership to classify this as a true “project” that requires resources and time.

We need to enlist the help of experts at our organization to make sure OnCore supports our processes and practices.

We will work with Forte’s project management office to make a plan for implementing Financials over the next 6-

12 months.

Charge Master

Used to store standard costs for financial events, based on the type of study (Rate

Base) and the location (Cost Center) where the procedure occurred.

Coverage Analysis Console

 Document rationale in the Qualifying

Clinical Trial (QCT) checklist

 Choose billing designations to indicate how costs will be reimbursed

 Link clinical procedures to subjectrelated charge master events

 View the billing grid

Financial Console

 Set study parameters

 Add protocol-related events

 Link clinical procedures to subjectrelated charge master events

 Add budget-only procedures

 Choose invoiceable milestones

 Create invoices

 Record and reconcile receipts

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