IRB+ User Manual for Online Submissions

IRB+
IRB+ Online Submissions User Manual
IRB+
User Manual for Online Submissions
Updated April 15 2007
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1. Contents
1.
CONTENTS .......................................................................................................................................... 2
2.
INTRODUCTION ................................................................................................................................ 3
3.
INVESTIGATORS ............................................................................................................................... 4
3.1 LOGIN SCREEN .................................................................................................................................. 4
3.1.1
Terms of Use ........................................................................................................................... 4
3.2 MY STUDIES SCREEN ........................................................................................................................ 5
3.3 MANAGING PROTOCOLS & SUBMISSIONS ......................................................................................... 6
3.3.1
Submitting a new protocol application ................................................................................... 6
3.3.2
Protocol Edit Screen ............................................................................................................... 7
3.3.3
Online Forms Tab ................................................................................................................... 8
3.3.3.1
3.3.3.2
3.3.3.3
3.3.4
Documents Tab ......................................................................................................................14
3.3.4.1
3.3.5
3.3.6
3.3.7
3.3.8
3.3.9
3.3.10
4.
Completing Online Forms ............................................................................................................. 9
Study Staff Online Form .............................................................................................................. 12
Demographic Information Online Form ...................................................................................... 13
Uploading Supporting Documents ............................................................................................... 14
Printable Forms .....................................................................................................................15
Security Tab ...........................................................................................................................17
Submit Tab .............................................................................................................................19
Creating Non-Initial Submissions..........................................................................................20
Meetings tab ..........................................................................................................................22
Correspondence tab ...............................................................................................................22
IRB ADMINISTRATORS ..................................................................................................................25
4.1 LOGGING ONTO IRB+ ......................................................................................................................25
4.2 ESUBMISSION INBOX ........................................................................................................................25
4.3 EDIT FORMS & DOCUMENTS SCREEN ..............................................................................................26
4.3.1
Managing Online Forms & Documents.................................................................................28
4.3.2
System Form ..........................................................................................................................29
4.4 EDIT FIELDS SCREEN .......................................................................................................................30
4.5 EDIT ESUBMISSION SETTINGS SCREEN .............................................................................................34
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2. Introduction
This document describes how to use the Online Submissions Module of IRB+. The Online
Submissions Module allows investigators to:
• Submit initial applications, continuing reviews, amendments, adverse events, unanticipated
problems and project completion applications online.
• Upload supporting documents like the consent form, full protocol description, advertising
material, etc.
• View their activity letters online and respond online.
• Check which IRB meeting their studies are scheduled for.
The Online Submissions Module integrates seamlessly with the IRB Administrator Module of
IRB+, allowing IRB Administrator to:
• Accept submissions online or return submissions to the PI for changes.
• View all information entered by the PI online and download the supporting documents for
the submission.
This document is divided into two sections.
Investigators - This section explains how the researcher community should use the
Online Submissions Module in IRB+.
IRB Administrators - This section explains how the IRB Administrators should use the
Online Submissions Module in IRB+.
All screen shots and examples in this user manual are of test information
only and utilize the demo system. The actual online forms, supporting
documents and printable forms in your Online Submissions Module will be
customized for you organization.
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3. Investigators
3.1
Login Screen
IRB+ is located at the following website: http://www.irbplus.com/. To use IRB+ you must have
Internet Explorer 6 or 7. Click the “Customer Login” button and enter your email address and
password in the following login page:
If you have forgotten your password click the “Click here if you have forgotten your password”
link. You will be asked to enter your email address. IRB+ will email the current password on your
account to this email address.
If you do not have a login contact your IRB office. They will add you as an investigator to IRB+
and give you a temporary password.
3.1.1 Terms of Use
It is important that you read and agree with the Terms of Use before using IRB+. The
Terms of Use are located in the left menu of the Login screen.
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3.2
IRB+ Online Submissions User Manual
My Studies Screen
After logging in you will see the “My Studies” screen that will be similar to the following screen
shot.
The screen contains the following sections:
• Planned Submissions: Displays all submissions that need to be sent to the IRB office. This
includes submissions that have been returned by the IRB office for changes.
• IRB Action Pending: Submissions that are awaiting review by the IRB office or by the IRB.
• Active Protocols: Displays all Protocols that are active.
• Exempt Protocols: Displays all Protocols that are exempt from IRB review.
• Closed/Expired Protocols: Displays all Protocols that have been closed or have expired.
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In the left menu, you can select from a number of actions.
New Protocol Application
New Continuing Review
New Amendment, Change or
Update
New Adverse Event
New Unanticipated Problem
Project Completion
3.3
Click this link to start a new online protocol application.
Click this link to start a new continuing review application for
one of your existing protocols.
Click this link to start a new amendment, change or update
application for one of your existing protocols.
Click this link to start a new adverse event application for one of
your existing protocols.
Click this link to start a new unanticipated problem application
for one of your existing protocols.
Click this link to start a new project completion application for
one of your existing protocols. .
Managing Protocols & Submissions
This sections describes all activities related to creating and submitting submissions e.g.
completing online forms, uploading documents, granting access to protocols.
3.3.1 Submitting a new protocol application
To create a new protocol application, click the “New Protocol Application” link on the top left of
your screen. You will see the following screen:
New Protocol Application Screen
Enter the protocol title and click the OK button to continue and you will then see the Protocol Edit
screen.
Note: You new protocol will appear in the “Planned Submissions” section of the My
Studies screen until you submit it to the IRB office.
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3.3.2 Protocol Edit Screen
The Protocol Edit screen allows you to manage all submissions for a protocol. The Protocol
Header, which is above the tabbed panel, displays general information about the protocol such as
the study title and PI. If you need to change the title of the protocol, you can enter the new title at
the top of the screen and click the “Save” button. All other fields in the Protocol Header are readonly.
You can quickly email the PI by clicking the PI’s email address in the Protocol Header. Similarly,
you can email the Study Coordinator by click the Study Coordinator’s email address in the
Protocol Header.
Each of the tabs in the Protocol Edit screen will be described in more detail in the sections below:
• Online Forms tab: All online forms that must be completed for this submission.
• Documents tab: Supporting documents associated with the submission.
• Printable Forms tab: A printable version of the submission and other printable documents
e.g. fax sheets, PI’s Assurance Sign-off Sheet.
• Submit tab: Allows you to electronically submit the submission to the IRB office for review.
• Security tab: Allows you to grant and remove access to personnel on the protocol.
The following tabs will be displayed once the initial submission has been submitted to the IRB
office:
• Meetings tab: All IRB Meetings this study has been scheduled for.
• Correspondence tab: View activity letters for this study and respond online.
• Init. Application: Initial application online forms, supporting documents and printable forms
for this study.
• Cont. Reviews: Continuing review submissions and associated online forms, supporting
documents and printable forms for this study.
• Amendments: Amendment submissions and associated online forms, supporting documents
and printable forms for this study.
• AEs: Adverse event submissions and associated online forms, supporting documents and
printable forms for this study.
• Unanticipated Problems: Unanticipated problem submissions and associated online forms,
supporting documents and printable forms for this study.
• Project Completion: Project completion submissions and associated online forms,
supporting documents and printable forms for this study.
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The screenshot below displays a newly created initial application.
In the left menu, you can select the following action.
Go to My Studies
Click this to return to the My Studies screen to view all your
protocols and submissions.
3.3.3 Online Forms Tab
The Online Forms tab lists all the online forms that you will need to complete before you can
submit the protocol to the IRB office. These forms should be familiar to you as they contain
questions similar to the paper-based forms you have used previously. As you complete each
form, the status of the form will change from “Incomplete” to “Complete”. Partially completed
forms may be saved as “In Process”. All incomplete forms will have a status in red and all in
process forms will have a status in beige to indicate that they require further action. Instructions
may be displayed next to each form to give further information on what the form contains and how
it must be completed.
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3.3.3.1 Completing Online Forms
To open a online form, click on the name of the form and it will be displayed in a new window.
For example, when the “Protocol Summary” online form is clicked for an initial application, the
following new window will be displayed.
Project Summary Online Form, Initial Application
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Entering data
• In the online forms the required fields are marked with a red * and must be entered before
saving. Some fields become required depending on the answers given to prior questions.
• Dates should be entered in the format mm/dd/yyyy.
• Numeric fields should only contain numbers, commas and decimal points.
Saving the Form
At the end of each online form, you will see a “Save” button, a “Save as ‘In Process’” button and a
“Cancel” button. If you click the “Save” button and a required field is unanswered, IRB+ will
remind you to specify an answer. If you would like to save the online form without completing all
the required fields, click the “Save as ‘In Process’” button. Note: the status of the online form
then remains at “In Process” until you go back and complete the form. Click the “Cancel”
button if you do not wish to save any of your changes.
Optionally Required Fields
Some fields in the online forms are optionally required depending on the value of other fields in
the form. For example, in the “Risks & Discomfort” form for initial applications, if you answer
“Yes” to the question “When you have completed your contact with the research participant, will
there be a debriefing session?”, then you will be required to explain the procedures for the
debriefing session.
Optionally Required Forms & Supporting Documents
In the online forms, specifying certain information will require you to fill out additional forms or
attach additional supporting documents. For example, in the “Description of Change” online form
in the amendment submission, if you check that the there is an “Consent Change” IRB+ will add a
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“Clean Consent Form” and “Consent Form with Changes Highlighted ” to the Documents tab.
For this reason it is important to check the Online Forms and Document tabs regularly to
ensure the submission has been completed.
Most of the online forms are self-explanatory. However, the following more complex
online forms are described in the sections below.
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3.3.3.2 Study Staff Online Form
The “Study Staff” online form contains all research personnel associated with this study and will
be required for all initial applications. You can replace a person or lookup a person by clicking
the “Lookup Person” button. Co-investigators and study coordinators may be added to the study
by clicking the “Add Co-Investigator” and “Add Study Coordinator” buttons. If you need to edit the
contact details of an existing person, click the “Edit Person” button.
Remember to click the “Save” button after you have finished editing the research
personnel.
Editing a Person
Once you click the “Edit Person” button, the person’s contact and other details will be editable as
shown above. Most fields in the Edit Person view are self-explanatory. The more complex fields
are explained in more detail below.
The Email address is used by that person to logon on to IRB+ so it is important to enter this
correctly.
The Date of Training of IRB training. All personnel are required to have up-to-date training.
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Find Person Screen
Click the “Add Co-Investigator” or “Add Study Coordinator” button to add personnel to the “Study
Staff” form with the specified role. The Find Person screen will be displayed.
Enter the first few letters of the person’s first name or last name and click the “Find” button. All
matching people in the system will be displayed. Click the person’s name to add the person to
the “Study Staff” form.
If you cannot find the person you are looking for, check the spelling of the person's name or
contact the IRB office and ask them to create this person's record.
3.3.3.3 Demographic Information Online Form
The “Demographics Information” online form is used to record the breakdown of participants by
ethnicity and gender. The total fields are ready only and will be automatically calculated as you
enter the participant figures.
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3.3.4 Documents Tab
The Documents tab indicates which documents must accompany this submission. As you
complete the various online forms the list of documents may change depending on your answers.
Hence, frequently return to the Documents tab to check what documents you need to submit.
3.3.4.1 Uploading Supporting Documents
Documents that are required for submission should be uploaded on the Documents tab in
electronic format (e.g. Microsoft Word, PDF, Excel etc.). To upload a document, use the “Click
here to upload the document” link. The “Upload Document” screen will be displayed.
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Upload Document screen
Click the “Browse…” button to select the file to upload. You can upload any file on your
computer. Click the “Upload” button to save this document to your submission.
Once the file is uploaded, the name of the document becomes a link and the status changes to
“Uploaded”. To see what you uploaded, click on the name of the document. At any time before
you electronically submit the application to the IRB office, you can re-upload the document if the
document changes by clicking the “Click here to upload a new document” link. To delete the
document, click the “Click here to remove the document” link.
If you do not submit the appropriate documents, either electronically or by mail, your
protocol may not be reviewed and you will not be able to perform your study.
3.3.5 Printable Forms
A printable version of each submission may be found under the “Printable Forms” tab e.g.
“Printable Single Project Approval Form”. Clicking on this link will open a new window containing
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a printable version of all the online forms for this submission. This document may be printed for
your files by clicking the “Print” button at the bottom of the window.
The “Printable Forms” tab also contains fax sheets such as the “Project Approval Sign-off Sheet”
that may be printed and faxed for sign-off.
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Printable Submission
Sign-off Fax Sheet
3.3.6 Security Tab
You can give personnel on this protocol permission to see and edit the protocol in IRB+. To grant
access to a protocol, go to the Security tab, select the person from the drop down and click the
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“Grant Access” button. To disable access, click the button next to the person’s name, under the
“Click button to disable access” title.
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3.3.7 Submit Tab
The “Submit” tab summarizes all items that must be completed before your protocol can be
electronically submitted and reviewed.
Once you have completed each of the items listed on the Submit tab, a “Submit” button will be
displayed.
Click on the “Submit” button to electronically submit the protocol application to the IRB office.
Please note, this is analogous to handing a paper copy of your protocol to the IRB office. Hence,
once you have submitted your protocol, you will not be able to make any changes to the
protocol. If you need to make a change after submission, contact the IRB office and they can
return your submission. Your returned submission will appear in the “Planned Submissions”
section of the “My Studies” screen.
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Once you submit, your submission will appear in the “Pending IRB Action” section of the “My
Studies” screen. If the IRB office returns the submission, you will receive email notification and
the submission will be moved to the “Planned Submissions” section of the “My Studies” screen to
allow you to make changes. The email will outline the changes that are required to the
submission before you can resubmit to the IRB office.
You will receive email notification when the IRB office accepts your protocol. The IRB office will
schedule the submission for IRB review and you may view the meetings the submission is
scheduled for and the activity letters for the submission on the “Meetings” and “Correspondence”
tabs.
3.3.8 Creating Non-Initial Submissions
Non-initial submissions, such as continuing reviews, amendments, adverse events, unanticipated
problems and project closures, can be created on protocols in IRB+.
To create a submission, click appropriate “New” link in the “My Studies” screen e.g. the New
Continuing Review link. The New Submission screen will be displayed:
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Select the protocol for which you wish to create the Continuing Review and click the OK button.
The drop down list will be populated with protocols in a valid status for continuing reviews.
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The new continuing review submission will be displayed in the “Protocol Edit” screen. You must
complete the online forms, upload the documents and submit as per an initial application
process.
3.3.9 Meetings tab
The “Meetings” tab display all meeting this study is scheduled for.
3.3.10 Correspondence tab
The “Correspondence” tab displays all correspondence activity letters from the IRB office. You
may view these activity letters by clicking the “View Letter” button. Some activity letters may
require a response, and for these activity letters you may respond online by clicking the “Click
here to respond online” link.
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Example Activity Letter
When you chose to respond online, the Online Response screen will be displayed. In this screen
you may enter response to the IRB questions and concerns and upload supporting documents.
Click the “Submit” button to submit your response to the IRB office.
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4. IRB Administrators
4.1
Logging onto IRB+
Members of the IRB office should logon to the WebKit with their email and IRB+ password.
4.2
eSubmission Inbox
The eSubmission Inbox shows recently submitted protocol applications, continuing reviews,
amendments, adverse events, unanticipated problems and project closures that require review.
Submissions remain in the eSubmission Inbox until you either return the submission to the PI to
make changes or accept the submission. Generally, you should leave a submission in the inbox
until all outstanding documents are received. The outstanding documents are listed on the right
side of the screen.
To return or accept a submission, click on the protocol, go to the submission, and click the
“Accept/Reject” tab. If the submission meets your approval, click the “Accept” button to accept
the submission. The PI will receive email notification that the study is approved.
If you wish to return the submission to the PI, enter the reasons for return and the changes that
should be made to the study in the text box. When you click the Reject button, the submission
will be returned to the PI and they will be emailed the reasons for return.
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4.3
IRB+ Online Submissions User Manual
Edit Forms & Documents Screen
The Edit Forms & Documents screen can be found under the Housekeeping menu. The Edit
Forms & Documents screen lets you customize the “Online Forms”, “Documents” and “Printable
Forms” tabs. Each form will have a submission type (e.g. initial application, amendment,
continuing review) and a form type, which may be:
• Web Form: This form appears on the Online Forms tab for the submission type.
• Document: This document appears on the Documents tab for the submission type. The
document can be uploaded to IRB+ in an electronic format.
• Printable Form: This document appears on the “Printable Forms” tab for the submission
type. This is a printable version of all online forms on the submission.
• Fax Sheet: This document appears on the “Printable Forms” tab for the submission type.
This is a printable fax sheet, often used as sign-off sheets for the submission.
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To edit a form or document, click on the name of the form or to create a new form, click the “New
Form” button. When you edit or create a form you will see the following screen:
Edit Form Screen – Dynamic Online Form
The above screen shot is of an dynamic online form. This is an online form whose fields and
instructions can be changed by the IRB office.
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Edit Form Screen – Custom Online Form
The above screen shot is of an custom online form. This is an online form whose fields and
instructions cannot be changed by the IRB office and may only be change by Third Sky. Custom
forms can be identified by the Form URL. Custom forms will always have a Form URL while
dynamic online forms will have no Form URL.
4.3.1 Managing Online Forms & Documents
To create a new or edit an existing online form or document supply the following information.
Specify the name of the form in the Form Name text box. This is the name that will appear on
the Online Forms, Documents or Printable Forms tab.
In the Form Type drop down, select from Web Form, Document, Printable Form or Fax Sheet.
Web forms appear in the Online Forms tab. Documents appear in the Document tab. Printable
Forms and Fax Sheets appear in the Printable Forms tab. Documents can be uploaded to IRB+
in electronic format. Printable Forms and Fax Sheets can be printed or filed in electronic format.
In the Submission Type drop down, pick from Initial Application, Continuing Review,
Amendment etc. This will determine the type of submission the online form or document will be
added to.
When IRB+ displays forms and documents it displays them in ascending order of the Form Order
field. Enter a number into this field. A best practice is to count by 10. That way, if you need to
create a new form that will appear between two existing forms, it is easy to pick an appropriate
Form Order number.
The Form URL field lets you override the default behavior for the given form type. You should
not edit this field.
The Instructions field is useful for the forms that appear in the Online Forms tab as you can tell
the researchers any important instructions for filling out the online form. These instructions will
appear next to the form name in the Online Forms tab. For Documents, these instructions will
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appear on the Submit tab next to the document name. For Printable Forms and Fax Sheets,
these instructions will appear on the Printable Forms tab next to the form name.
The Document Instructions field contains any instructions for filling out this document. These
instructions appear on the Documents tab next to the document name.
If the Auto Create checkbox is checked, this form will automatically be created when the
investigator starts the corresponding submission. For example, in the screen shot above, the
“Principal Investigator & Co-Researchers” online form is automatically created for each initial
application. If you do not check the “Auto Create” check box, make sure one of your online forms
has a rule that adds this form to the protocol. Otherwise, the investigators will never be able to
access the form (refer to the Edit Rules section below for instructions on how to create rules).
The Track Date Received checkbox only applies to Documents. If you want to track the date
that the document was received, check this checkbox. If this checkbox is checked the PI will be
reminder to upload these documents to the WebKit. These documents will also appear in the
Outstanding Documents column in the ESubmission Inbox screen. If you do not want this
document to appear in the “Outstanding Document” column, e.g. the protocol can be reviewed
without this document, leave the checkbox unchecked.
4.3.2 System Form
The System form is a special online form that stores special fields used by IRB+ i.e. text of emails
to be sent out.
This form must not be edited or deleted.
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4.4
IRB+ Online Submissions User Manual
Edit Fields Screen
To change the questions on a online form, click the “Edit Fields” link to the right of the online form
on the Manage Forms & Documents screen. When you click the button, you will see the Edit
Fields screen as shown below:
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To change an existing field, click on the field name or to create a new field, click on the “New
Field” link in the left navigation bar. When you edit or create a field you will see the following
screen:
Enter the name of the field in the Name box. This is the name that will be shown if the field is
required e.g. “Review Process is a required field”.
Enter the text of the question in the Text box. You can use the standard HTML tags to format the
text of the question. For example, <B> indicates that bold should begin and </B> indicates that
bold should end. Other HTML tags worth noting include <U> and </U> for underline and <I> and
</I> for italics. HTML is case-insensitive so you can use either upper or lower case letters.
However, make sure you correctly end all tags or the generated online form may look different
than expected. You can use the <br> to enter a line break.
Select one of the following from the Type drop down to indicate how the investigator will
enter/select the answer.
Text
Yes/No
Yes/No/NA
Check Boxes
Check Boxes
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The investigator will type the answer into a
single line text box.
The investigator will pick from either a Yes or
No radio button.
The investigator will pick from either a Yes,
No or N/A radio button.
The investigator will pick from one or more
check boxes.
The investigator will pick from one or more
check boxes. An checkbox labeled “Other” will
automatically be added to the end of the list
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Number
with an textfield next to the checkbox. If the
user checks “Other” they will be required to
enter a description in the textfield.
The investigator will type the answer into a
multi-line text box.
The investigator must enter a number.
Date
The investigator must enter a valid date.
Drop Down List
The investigator will pick an item from a drop
down list.
The investigator will pick one item from a series
of radio buttons.
This field actually provides instructional text
and no answer is expected.
Multi-Line
Radio Buttons
Instructions
The List Items section lets you specify the items for check boxes, drop down lists, and radio
buttons. To add a new item to the list, enter it into the top box and click the Add Item button. To
change an existing item, select it from the list, change it in the top box and click the Update Item
button. To remove an item from the list, select it from the list and click the Delete Item button.
List items will be displayed in the online form in the order they have been entered. Do not use
commas or HTML tags in the list items as this will cause the page to function incorrectly.
The Length field lets you specify the maximum number of characters for a Text field.
If the investigator must answer this question before they can submit the application, check the
Required checkbox. Required fields will have a red asterisk next to them in the online form.
You must save the field before the Rules section only becomes available. When you return to
the field, you will see a New Rule button. Clicking this button will display the following screen.
The rule will be triggered based on a specific answer. When the rule triggers, there are two
possible actions: make another field mandatory OR add a form/document to the protocol. If you
choose the first radio button, you will need to select which field becomes mandatory. Since the
field has to exist before you can create the rule, the recommended process is to create all the
fields first then go back and create the rules. If you choose the second radio button, you will need
to select which form/document to add to the protocol. Again, since the form/document must
already exist in order for you to create the rule, it is recommended that you create all the
forms/documents first before creating the rules.
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You can create as many rules as you want for a given field and a given value. For example, if
two fields become mandatory when the answer to the current field is “Yes”, you can create two
rules for the “Yes” answer. To change an existing rule, just click on the rule on the “Edit Field”
screen.
Back on the Edit Field screen, the next box under the rule section is the Indent box. The indent
box lets you create a hierarchy of questions. Entering “1” in this box gives the question a small
indent; entering “2” in this box gives the question a double indent; and so on.
The Order field lets you specify the order that the questions will appear on the online form. The
questions will appear in ascending order. A best practice is to count by 10 when initially
establishing the order. Later, when a new question must be inserted between two existing
questions, you can then pick the appropriate order number.
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Edit eSubmission Settings Screen
The Edit eSubmission Settings screen can be found under the Housekeeping menu. The Edit
eSubmission Settings screen lets you customize the emails sent out upon acceptance or rejection
of a submission, and the values show “All Submissions” tab e.g. All Continuing Reviews, All
Amendments etc.
Types of settings:
• <Submission Type> Accepted – Settings with a name in this format (e.g. Adverse Event
Accepted) contain the format of the emails to be sent to the PI upon acceptance of the
submission by the IRB office.
• <Submission Type> Rejected – Settings with a name in this format (e.g. Adverse Event
Rejected) contain the format of the emails to be sent to the PI upon rejection of the
submission by the IRB office.
• <Submission Type> Field 1 – Settings with a name in this format (e.g. Adverse Event Field
1) contain the name of the online field to be shown as the first column in the “All
Submissions” tab to help differentiate different submissions of the same type (e.g. in the All
Adverse Events, this field is the Date of Adverse Event).
• <Submission Type> Field 2 – Settings with a name in this format (e.g. Adverse Event Field
2) contain the name of the online field to be shown as the second column in the “All
Submissions” tab to help differentiate different submissions of the same type (e.g. in the All
Adverse Events, this field is the Description of AE).
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IRB+
IRB+ Online Submissions User Manual
Click on the setting name to edit the setting and you will see the Edit Setting screen. Any text
within angle brackets (e.g. <PI Full Name>) is dynamic information and will replace automatically
replaced with the appropriate information for that submission.
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