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CLINCAPTURE
USER’S GUIDE
Version 2.1.0
CLINCAPTURE
1208 E. ARQUES AVE, SUNNYVALE, CA
800-987-6007 • WWW.CLINCAPTURE.COM
REVISION HISTORY
Revisions
Version Number
Revision Date
Notes
1.0.1
Jan. 28, 2013
Original document
1.0.3
Aug. 16, 2013
Rewrite, new style, and formatting
Version update for 1.0.3
1.0.3
Sep. 23, 2013
V
Version update for 1.0.3
2.0.2
Apr. 1, 2014
Version Update, and formatting
2.1.0
May 5, 2015
Version update for 2.1.0
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TABLE OF CONTENTS
1 INTRODUCTION TO CLINCAPTURE ................................................................. 8
1.1
Target Audience......................................................................................... 8
1.2
Document Organization ............................................................................. 8
1.3
Typographical Conventions ........................................................................ 8
1.4
License Information ................................................................................... 9
1.5
Referencing ClinCapture ............................................................................ 9
2 KEY CONCEPTS....................................................................................... 10
2.1
Functional Overview ................................................................................ 10
2.2
Typical EDC Workflow .............................................................................. 10
2.3
Color Themes........................................................................................... 11
2.4
Interface Language .................................................................................. 12
2.5
About Users ............................................................................................. 13
2.5.1 User Levels ........................................................................................... 13
2.5.2 User Types ........................................................................................... 13
2.5.3 User Roles ............................................................................................ 14
2.5.4 CRF Masking......................................................................................... 15
2.6
ClinCapture Modules ............................................................................... 15
2.7
Changing the Current Scope ..................................................................... 18
2.8
One-Click Access™ ................................................................................... 19
3 GETTING STARTED .................................................................................. 21
3.1
How to Login ........................................................................................... 21
3.1.1 Login Problems .................................................................................... 22
3.1.2 Changing Your Password ..................................................................... 23
3.1.3 Updating Your User Profile .................................................................. 23
3.1.4 Logging Out .......................................................................................... 24
3.2
ClinCapture Icons ..................................................................................... 25
3.2.1 Status Icons .......................................................................................... 25
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3.2.2 Frequently Used Icons ......................................................................... 25
3.2.3 Other Icons .......................................................................................... 26
3.3
Home Page Framework ............................................................................ 27
3.3.1 Home Page Header .............................................................................. 28
3.3.2 Navigation Bar ..................................................................................... 29
3.3.3 Side Panel ............................................................................................ 30
3.3.4 Main Body ............................................................................................ 30
3.3.5 Home Page Footer ............................................................................... 30
3.4
Last Row Accessed ................................................................................... 31
4 SUBMIT DATA ....................................................................................... 32
4.1
Subject Matrix ......................................................................................... 32
4.1.1 Subject Matrix Pop-up ......................................................................... 32
4.1.2 Subject Matrix Pop-up Action Icons .................................................... 34
4.1.3 Adding a Subject .................................................................................. 35
4.1.4 Scheduling a Subject ............................................................................ 35
4.1.5 Locking or Unlocking a Subject Record ............................................... 35
4.1.6 Dynamic Groups .................................................................................. 36
4.1.7 Submitting Data for a Subject.............................................................. 37
4.1.8 Show More Subject Information ......................................................... 37
4.1.9 Finding and Organizing Data................................................................ 38
4.1.10 View Event Details ............................................................................... 40
4.1.11 Study Subject Record ........................................................................... 40
4.2
Add Subject ............................................................................................. 45
4.2.1 Add Subject from Subject Matrix ........................................................ 45
4.2.2 Add Subject from Tasks Menu ............................................................. 47
4.2.3 Assign or Reassign Subject to Site ....................................................... 47
4.2.4 Add a Subject to Multiple Studies ....................................................... 48
4.3
Edit Subject ............................................................................................. 48
4.3.1 Editing Global Information .................................................................. 48
4.3.2 Editing Study-specific Information ...................................................... 49
4.4
Schedule Event ........................................................................................ 50
4.4.1 Scheduling a Study Event..................................................................... 50
4.5
Calendared Event..................................................................................... 52
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4.6
View and Update Events .......................................................................... 54
4.6.1 Viewing Events..................................................................................... 54
4.6.2 Updating Events................................................................................... 55
4.6.3 Event Status ......................................................................................... 57
4.6.4 Electronic Signatures ........................................................................... 58
4.7
Entering CRF Data .................................................................................... 61
4.7.1 Manual Data Entry ............................................................................... 61
4.7.2 Subject Randomization ........................................................................ 66
4.7.3 CRF Unavailable ................................................................................... 68
4.7.4 Double Data Entry ............................................................................... 68
4.7.5 CRF Status ............................................................................................ 69
4.7.6 Modifying a Previously Saved CRF ....................................................... 70
4.8
Importing CRF Data .................................................................................. 70
4.8.1 Data Import Options ............................................................................ 71
4.8.2 Data File Import ................................................................................... 72
4.8.3 Data File Format .................................................................................. 73
4.8.4 Data File Validation.............................................................................. 73
4.9
Notes and Discrepancies .......................................................................... 74
4.9.1 Discrepancy Note Types ...................................................................... 75
4.9.2 Discrepancy Note Status ...................................................................... 76
4.9.3 Creating Discrepancy Notes................................................................. 77
4.9.4 Viewing a Discrepancy Note ................................................................ 80
4.9.5 Updating a Discrepancy Note .............................................................. 81
4.9.6 Managing Discrepancy Notes .............................................................. 84
4.9.7 Finding and Organizing Discrepancy Notes ......................................... 87
4.9.8 Downloading Discrepancy Notes ......................................................... 89
4.9.9 Generating Discrepancy Correction Forms (DCFs) .............................. 89
4.10
Special Permissions .............................................................................. 91
5 MONITOR AND MANAGE DATA ................................................................. 93
5.1
Source Data Verification .......................................................................... 93
5.1.1 Verifying Source Data .......................................................................... 94
5.1.2 Customizing the View .......................................................................... 99
5.1.3 Finding and Organizing SDV Data ...................................................... 100
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5.1.4 Viewing SDV Status ............................................................................ 100
5.1.5 Resetting SDV Status ......................................................................... 100
5.2
Study Audit Log ..................................................................................... 100
5.2.1 Viewing Audit Logs for a Subject ....................................................... 101
5.2.2 Changes Tracked in the Study Audit Logs.......................................... 102
5.2.3 Exporting Study Audit Logs for a Subject .......................................... 103
5.3
Medical Coding ...................................................................................... 104
5.3.1 Configuring Medical Coding for a Study ............................................ 106
5.3.2 Coding a Medical Term ...................................................................... 106
5.3.3 Medical Coding Status ....................................................................... 108
5.3.4 Resetting Medical Coding Status ....................................................... 108
5.4
Evaluate CRF Data .................................................................................. 108
5.4.1 Study Configuration ........................................................................... 109
5.4.2 CRF Evaluation Widget ...................................................................... 110
5.4.3 Performing CRF Evaluation ................................................................ 111
5.5
Rules ..................................................................................................... 112
5.5.1 Rules Studio ....................................................................................... 113
5.5.2 Designing Rules .................................................................................. 114
5.5.3 Editing Rules ...................................................................................... 115
5.5.4 Importing Rules ................................................................................. 115
5.5.5 Exporting a Rule ................................................................................. 116
5.5.6 Testing Rules ...................................................................................... 116
5.6
Reports.................................................................................................. 119
5.7
Special Permissions................................................................................ 120
6 EXTRACT DATA .................................................................................... 122
6.1
Dataset Creation .................................................................................... 122
6.1.1 Defining a Dataset ............................................................................. 122
6.1.2 Generating Datasets .......................................................................... 126
6.1.3 Viewing and Managing Dataset Definitions ...................................... 126
6.2
Downloading Datasets ........................................................................... 127
6.2.1 Browser Settings for Downloading Files ............................................ 129
6.3
Editing Dataset Definitions..................................................................... 129
6.4
Dataset File Formats .............................................................................. 131
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6.4.1 Header Table Format ......................................................................... 131
6.4.2 Variable Naming Convention ............................................................. 132
6.4.3 Supported Extract Formats................................................................ 132
6.4.4 SAS Format via CDISC ODM ............................................................... 134
6.5
Special Permissions................................................................................ 134
6.6
Annotated CRFs ..................................................................................... 135
7 GLOSSARY .......................................................................................... 137
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1 INTRODUCTION TO CLINCAPTURE
This document describes the features of ClinCapture 2.1.0. You access the ClinCapture software using a
web browser. For a list of supported web browsers, consult the Compatibility and System Requirements
page on ClinCapture’s community website.
Keeping up with the open source spirit, ClinCapture has established a community where users and
developers can freely collaborate to further improve and enrich the system, as well as access the source
code and the documentation. Visit the ClinCapture Community to learn how to use its various clinical
research resources, and actively participate!
1.1 Target Audience
This document is intended for clinical researchers involved in data collection, submission, monitoring,
management, and extraction. As such, it does not cover advanced configuration and programming
topics that are fully discussed in the ClinCapture Administrator’s Guide and the ClinCapture
Programmer’s Guide.
1.2 Document Organization
After the Introduction, Key Concepts, and Getting Started sections, the body of this document is
organized according to the modules in the ClinCapture Task Menu, excluding the Study Setup and
Administration modules, which are covered in the ClinCapture Administrator’s Guide:
 Submit Data
 Monitor and Manage Data
 Extract Data
1.3 Typographical Conventions
Example
Description
User Roles
Blue, underlined font indicates a hyperlink inside this document or on the
Web.
Forgot Password
Light blue, underlined font indicates a hyperlink inside the ClinCapture
system.
Submit
Bold font indicates verbatim text from ClinCapture, often used to identify a
button, icon, or field.
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Home
Italics font indicates a webpage, document name, or emphasis.
1.4 License Information
ClinCapture is distributed under the GNU Lesser General Public License (GNU LGPL). The GNU Lesser
General Public License is a free software license; as such, it grants you the following freedoms:




The freedom to run the program for any purpose.
The freedom to study how the program works, and to adapt it to your needs.
The freedom to redistribute copies so you can help your neighbor.
The freedom to improve the program and release your improvements to the public, so that the
whole community benefits.
 You may exercise the freedoms specified here, provided that you comply with the expressed
conditions of this license. The LGPL is intended for software libraries, rather than executable
programs. The principal conditions are:


You must conspicuously and appropriately publish on each copy distributed an appropriate
copyright notice and disclaimer of warranty and keep intact all the notices that refer to this
license and to the absence of any warranty; and give any other recipients of the program a
copy of the GNU LGPL along with the program. Any translation of the GNU LGPL must be
accompanied by the GNU LGPL.
If you modify your copy or copies of the library or any portion of it, you may distribute the
resulting library provided you do so under the GNU LGPL. However, programs that link to
the library may be licensed under terms of your choice, so long as the library itself can be
changed. Any translation of the GNU LGPL must be accompanied by the GNU LGPL.

If you copy or distribute the library, you must accompany it with the complete
corresponding machine-readable source code or with a written offer, valid for at least three
years, to furnish the complete corresponding machine-readable source code. You need not
provide source code to programs which link to the library.
 Any of these conditions can be waived if you get permission from the copyright holder. Your fair
use and other rights are in no way affected by the above.
 For details see http://www.gnu.org/licenses/lgpl-2.1.html, or LICENSE.txt provided with the
ClinCapture distribution.
1.5 Referencing ClinCapture
If you used ClinCapture to capture data for your study, you can reference it as follows:
“Data collection and management for this study was performed using ClinCapture, an open source
system, version 2.1.0.”
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2 KEY CONCEPTS
This section introduces the key concepts embodied in ClinCapture, presents a typical Electronic Data
Capture (EDC) workflow, and describes the role-based user interface and functionality.
2.1 Functional Overview
ClinCapture provides a comprehensive set of role-based features to perform EDC during clinical trials,
including:
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Creating and managing studies
Creating and managing users and sites
Adding and randomizing subjects
Scheduling Events, also known as visits
Entering clinical data in Electronic Case Report Forms (eCRFs)
Optionally performing double data entry
Optionally performing CRF evaluation
Performing medical coding
Raising and resolving Notes & Discrepancies, also known as queries
Performing Source Data Verification (SDV)
Applying electronic signatures
Creating and managing datasets
Importing and exporting data
Interfacing programmatically through a web service API to other eClinical systems such as ePRO,
CTMS, IWRS, and Core Labs
2.2 Typical EDC Workflow
The figure below illustrates a typical EDC workflow in ClinCapture from Study configuration, to data
locking.
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Figure 1: Typical EDC Workflow in ClinCapture
This workflow can be changed to meet your specific study requirements. For example, an Investigator or
Study Administrator may enter the data, or the data may be imported from an external source, such as a
core lab. Subjects may be added automatically when ClinCapture is integrated with a CTM system.
Discrepancy management may not be enabled, etc.
2.3 Color Themes
ClinCapture can be configured with different colors to avoid possible confusion between the different
instances: Development, Training, and Production, as illustrated in Figure 2. This avoids entering training
data in the Production instance, for example. The actual color chosen for your specific implementation
may vary and you should consult your case report form (CRF) completion guidelines for details.
There are four color themes you can choose from: Blue, Dark Blue, Green, and Violet.
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Figure 2: Typical color theme assignment
2.4 Interface Language
The ClinCapture interface can be configured to display in different languages.
There are two languages you can choose from: English and Russian.
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2.5 About Users
In ClinCapture, each user is assigned a user level, type, and role. The user level, type, and role
combination determines the ClinCapture Modules shown in the Tasks menu and the features the user
can access.
2.5.1 User Levels
Each user is assigned to a single user level: System-level, Study-level, or Site-level. The user level is
determined when the user is created and assigned to either a Study or a Site, and cannot be changed
thereafter.
 System-level users can perform tasks across all Studies, including performing tasks at each Site
within that Study. These users can set their current scope to any Study or any Site within a
Study. The user role and user type cannot be changed.
 Study-level users can perform tasks at the Study level, including performing tasks at each Site
within that Study. These users can set their current scope to the Study or any Site within the
Study. They can also be assigned to multiple studies.
 Site-level users can only perform tasks at a Site for which they have been assigned. A Site-level
user can be assigned to multiple Sites.
2.5.2 User Types
ClinCapture has two user types: Administrator and User. A user type is assigned when the user is
created, and can be changed at any time.
The assigned user type applies to all Studies and Sites in the system. That is, a user cannot have different
user types for different Studies and Sites.
User Type: Administrator
Administrator user types have access to the features in the Administration module and can perform the
following tasks:
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
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Create new Studies
Work with information across multiple Studies
Manage User accounts
Schedule data import and export jobs
Administrator user types can create, modify, and remove users, except for the System Administrator
(root).
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User Type: User
User user types cannot access the features in the Administration module. They can access features to
work on Studies or Sites they have been granted access to, such as adding Study Subjects, scheduling
Study Events, and completing CRFs.
2.5.3 User Roles
User roles in ClinCapture are based on the roles typically found in clinical trials and in other forms of
clinical research. The user role determines the features a user can access within a particular Study or
Site. The user roles supported by ClinCapture are:
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System Administrator (root)
Study Administrator
Study Monitor
Site Monitor
Study Coder (only visible if Study parameter, Allow medical coding, is yes)
Study Evaluator (only visible if System or Study parameter, Allow CRF evaluation, is yes)
Investigator
Clinical Research Coordinator
The user roles available at the Study-level are different from the roles available at the Site-level. A user
can have a different role in the Study or Site in which they are assigned, as long as the new role remains
in the same level (Study or Site) as the initial role.
Table 1: ClinCapture supported user level, role, and type combinations
User Level
User Role
User Type
System Level
System Administrator
Administrator
Study Level
Study Administrator
Administrator
Study Monitor
User
Study Coder
User
Study Evaluator
User
Investigator
User
Clinical Research Coordinator
User
Study Evaluator
User
Site Monitor
User
Site Level
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2.5.4 CRF Masking
When site level users are created in ClinCapture, either Clinical Research Coordinators or Monitors, the
study administrator has the option to mask, or hide, one or more CRFs from the user. When a CRF is
masked, the user cannot take any action on the masked CRFs.
Note that masking is disabled for users with a role of Investigator.
2.6 ClinCapture Modules
Table 2 lists the ClinCapture Modules and main tasks available for each user role. When your user type
or role is not allowed to access a particular ClinCapture Module or task, it does not appear in the Tasks
menu.
Table 2: Available Modules and Tasks per User role
User Role
ClinCapture Module
Tasks
System Administrator
Submit Data

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
Subject Matrix
Notes & Discrepancies
Import Data
Schedule Event
View Events
Monitor and Manage Data

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
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


Source Data Verification
Study Audit Log
Rules
Groups
CRFs
Code
Reports
Extract Data
 Datasets
Study Setup
 View and Build Study
 Assign Users
 System
Administration
(only available for Administrator
user types)






Other
 Update Profile
 Help
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Studies
Sites
Users
CRFs
Jobs
Subjects
15
Study Administrator
Study Monitor
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

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Support
Log Out
Forums
About
Submit Data





Subject Matrix
Notes & Discrepancies
Import Data
Schedule Event
View Events
Monitor and Manage Data

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
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

Source Data Verification
Study Audit Log
Rules*
Groups*
CRFs*
Code
Reports
Extract Data
 Datasets
Study Setup
 View and Build Study
 Assign Users
 System
Administration
(only available for Administrator
user types)





Sites
Users*
CRFs*
Jobs*
Subjects*
Other






Update Profile
Help
Support
Log Out
Forums
About
Monitor and Manage Data






Subject Matrix
View Events
Source Data Verification
Notes & Discrepancies
Study Audit Log
Reports
Extract Data
 Datasets
Other
 Update Profile
 Help
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



Study Coder
Study Evaluator
Investigator
Clinical Research Coordinator
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Support
Log Out
Forums
About
Monitor and Manage Data
 Code
Other






Monitor and Manage Data
 Evaluate CRF
 Notes & Discrepancies
Other
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
Update Profile
Help
Support
Log Out
Forums
About
Submit Data


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
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
Subject Matrix
Add Subject
Notes & Discrepancies
Schedule Event
View Events
Import Data
Extract Data
 Datasets
Other






Update Profile
Help
Support
Log Out
Forums
About
Submit Data






Subject Matrix
Add Subject
Notes & Discrepancies
Schedule Event
View Events
Import Data
Other
 Update Profile
 Help
ClinCapture User’s Guide 2.1.0
Update Profile
Help
Support
Log Out
Forums
About
17
Site Monitor




Support
Log Out
Forums
About
Monitor and Manage Data





Subject Matrix
View Events
Source Data Verification
Notes & Discrepancies
Study Audit Log
Extract Data
 Datasets
Other






Update Profile
Help
Support
Log Out
Forums
About
* Available from Study-level only
2.7 Changing the Current Scope
ClinCapture limits the information you can access based on the current scope. The current scope is
either the Study-level or Site-level.
Note: A Study can include one or more Sites.
At the Study-level, you have access to information from all the Sites included in the Study. However, at
the Site-level you can only access information specific to a particular Site. Therefore, if you work with
more than one Study or Site, it is important to set your scope according to the task you want to perform.
To change the current scope:
1. Click the Change Study/Site link, just above the Navigation Bar.
2. Select the desired Study or Site. Site names are indented under the Study name.
3. Click Change Study/Site to open the Confirm Changing Study page.
4. Click Continue.
5. Click Submit to confirm your scope change.
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Figure 3: Change current Study/Site page
To automatically select a Study when you login, set it as the Default Current Study in your User Profile.
2.8 One-Click Access™
The ClinCapture One-Click Access™ feature allows you to perform many essential functions in just one
click from the Subject Matrix, such as data entry, scheduling events, performing Source Data Verification
(SDV), and signing eCRFs.
To trigger One-Click Access, position your cursor over a Study Event status icon and after a short delay a
pop-up will appear. For a faster reaction, click the icon.
Figure 4: One-Click Access popup
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The pop-up only contains the action icons valid for your role and the clinical data status. For example if
your role is Investigator, a Sign icon appears only if the following conditions have been met:
 All the required CRFs have been completed
 The data has been verified according to the SDV requirement
 All the queries are closed
Notes and Discrepancies are also directly accessible from the pop-up. Click the flag icon to view the list
of discrepancies related to a particular subject, event, or CRF. The flag color indicates the status of the
discrepancy, see Discrepancy Note Status. When multiple discrepancy statuses exist, New takes
precedence over Updated, which has precedence over Closed. Annotations and Reason For Changes
notes are not reported in the pop-up. For details about notes, see Notes & Discrepancies.
One-Click Access saves time by drastically reducing the number of clicks and accelerating your data
collection, verification, and approval processes.
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3 GETTING STARTED
This section shows you how to get started using ClinCapture. It explains how to login, reset your
password, change your user profile, and logout.
3.1 How to Login
To access the ClinCapture Login page, use the URL provided in your CRF Completion Guidelines, or
through your Study Administrator. Please note that your company logo may appear at the bottom of the
Login page.
Figure 5: ClinCapture login page
Useful resource links available at the lower left of the page include:
 About: Display the ClinCapture license. See License Information for details.
 Support: Get support for any technical issue. Fill out the form and click Submit to send a
message to the Study Administrator. You can also use the Community or Forums links on the
login page to share your current issue or question with other ClinCapture users and developers.
 Forums: Open the ClinCapture Forum page where users can discuss all things ClinCapture.
 Community: Open the ClinCapture Community page which provides valuable information and
links to the developers’ workspace, getting started with ClinCapture, forums, news and
upcoming events, a CRF library, and much more.
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The ClinCapture software version appears at the lower right of the page.
To login, enter your user name and password, and click Login. If the credentials you entered are valid,
the home page appears, see Home Page Framework.
If the Study (or Site) you are working with is locked of frozen, that is they are no longer accepting data
entry, the following message appears.
Figure 6: Frozen/Locked message
3.1.1 Login Problems
Your account may be administratively locked if you tried to login too many times, or if you have not
logged in for an extended period of time. In this case, contact your Study administrator or click the
Support link to get help with your account.
If you simply forgot your password, you can request a new one, as follows:
1. Click the Forgot Password link on the Login page to open the Request Password Form page.
2. Enter your User Name, Email, and your Challenge Question/Answer.
3. Click Submit Password Request.
If the information you provided was correct, you will receive an email with your temporary password.
This temporary password allows you to login to establish a new password. See Changing Your Password
for details.
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If you do not receive an email with a temporary password, contact your Study Administrator (you can
click the Support link on the Login page to send your Study Administrator a message).
3.1.2 Changing Your Password
Your new password must meet the password policy set by your Administrator and may require a
combination of upper case and special characters. Please note that the system may also have a policy of
preventing you from reusing previously used passwords. Please contact your Study Administrator for
details on the password policy.
To reset your password:
1. Click the link in the email you received to open the Reset password page.
2. Enter your old (or temporary) password.
3. Enter your new password, ensuring it meets the system password policy.
4. Confirm your new password by entering it again.
5. Set your challenge question and answer.
6.
Click Change Password.
3.1.3 Updating Your User Profile
To update your user profile:
1. On the Navigation Bar, select Tasks > Update Profile to open the Change User Profile page.
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2. Make the necessary changes to your name, email address, default active Study, password
challenge question, password, and/or phone number, and click Continue.
3. Verify the information, and click Submit to save the changes, or click Back to make additional
changes. A message in the Alerts and Messages areas of the Left Panel notifies you that your
profile was updated successfully.
3.1.4 Logging Out
Click the Log Out link to exit ClinCapture.
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3.2 ClinCapture Icons
ClinCapture uses icons to represent the state of certain objects, such as Study Events and CRFs, or to
initiate an operation on them, for example to apply an electronic signature on a Subject’s casebook.
The color of the icons depends on your ClinCapture color scheme. For details, see Color Themes.
3.2.1 Status Icons
The Status Icons indicate the status of a particular Study Event and its Case Report Forms (CRFs). The
Study Event status is based on the overall and total status of the CRFs in a Study. That is, if three CRFs in
a Study were completed, but a fourth one just started data entry, the Event status shows the Data entry
started icon. The Event status also indicates if the CRFs are Completed or Source Data Validated.
Icon
Meaning
Not started
Scheduled
Data Entry Started
Stopped
Skipped
Completed
Initial Data Entry Completed
Coded
Not Coded
Source Data Validated (SDV)
Signed
Locked
Removed
3.2.2 Frequently Used Icons
The availability of a particular icon and its action when you click it are dependent on your user role. They
are customized to your needs and responsibilities.
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Icon
Meaning
Description
View
Click to see the details of the function associated with the icon.
Edit
Click to change the descriptions associated with the function.
Set Role
Click to assign roles for the User within the Study.
Remove
Click to remove a function.
Lock
Click to lock subject records.
Unlock
Click to unlock subject records.
Restore
Click to restore a function that was previously removed. (The icon appears only
after a function has been removed.)
Print
Click to send output to a pop-up window then use your browser print function to
send this output to the printer, or click on the Print button inside some windows.
3.2.3 Other Icons
Icon
Meaning
Administrative editing
Archive
Calendar
Create new
Delete
Discrepancy Note: Add
Discrepancy Note: New
Discrepancy Note: Not Applicable
Discrepancy Note: Closed
Discrepancy Note: Updated
Download
Export/Test/View in context
Form contains changed/unsaved data
Form has unchanged data
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Help
New version
Reassign
Remove
Un-archive
3.3 Home Page Framework
The ClinCapture Home page displays after you log in, change a Study (or Site), or click Home in the
Navigation Bar. What you see on the Home page, and the tasks available to you, depend on your user
role and user type.
Regardless of the user role, the Home page contains the following common areas:





Header
Navigation Bar
Side Panel
Main Body
Footer
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Figure 7: ClinCapture Home page
3.3.1 Home Page Header
The Home page header is the top area, just above the Navigation Bar. It contains:
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 Name of Current Study: The current Study name, and the current Site if one is selected. Click
the name to read more information about the Study or Site.
 Change Study/Site: Allows you to change the current Study or Site. See Changing the Current
Scope for more details.
 User Name and Role: The name of the user currently logged in to ClinCapture and their assigned
role, such as Study Monitor.
 Flag: Indicates the language locale for the system.
 Log Out: Ends your ClinCapture session.
3.3.2 Navigation Bar
The Navigation Bar, at the top of the Home page, provides access to the most commonly used
ClinCapture features based on your user role.
 Home: Shows the Home page for the current Study or Site.
 Subject Matrix: Shows the Events status for all Subjects within your current scope: Study or Site.
You can view and perform various operations on Subjects, Events, and associated CRFs. There is
one Subject per row, starting with the Study Subject ID in the first column. The other columns
are for each Event Definition in the Study. Each cell contains a colored icon that identifies the
status of the Event(s) for the Study Subject. Move the cursor over an icon in the matrix to view
and access a Subject's Data and Actions for that Event. Refer to the icon legend in the Side Panel
for icon descriptions. See Subject Matrix for more details.
 Code: Allows you to perform medical coding on medical terms that have been reported in CRFs.
 SDV: Allows a Study or Site Monitor to view the source data verification information for subjects
and data in a Site or Study. This feature only appears in the Navigation Bar for Study or Site
Monitor roles. See Source Data Verification for more details.
 Add Subject: Allows you to add a new Subject to a Study. This item only appears in the
Navigation Bar for Investigator and CRC roles. See Add Subject for more details.
 Notes & Discrepancies: Serves as a venue for query and discrepancy management. This feature
allows you to verify the accuracy and completeness of data gathered in a particular clinical trial.
Use this set of tools to flag and track issues, such as incomplete and inaccurate data, that arise
when capturing, monitoring, and managing data in a Study. This could also be used to facilitate
communication between Users, such as Clinical Research Coordinators and Monitors, to resolve
and clarify critical issues with dispatch. See Notes and Discrepancies for more details.
 Study Audit Log: Provides a history of actions for Subjects in the Study. See Study Audit Log for
more details.
 Tasks: Contains a menu of actions you can perform in ClinCapture. The actions are grouped into
modules in the Tasks menu. Modules and items included in the Tasks menu depend on the
allowable activities linked and assigned to your user role.
 Search Box and Go Button: Allows you to view a history of Events for a particular Subject and to
access other information about the Subject. Enter the Study Subject ID in the search box, and
click Go.
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3.3.3 Side Panel
The Side Panel is the area along the left edge of the page. The Side Panel is separated into sections
which can be expanded and collapsed. Click the downward facing triangle ( ) to the right of the section
name to expand a section and show its information, or click the minus sign ( ) to collapse a section and
hide its information.
 Alerts and Messages: Displays alerts and message when you perform actions in ClinCapture. For
example, after you log in, a message reports the date you last logged in. Look here for
confirmation that an action you performed was successful, or to see if there were any errors.
 Instructions: Provides brief directions or a summary of what you can do at that point in
ClinCapture. For more information, click the Help button (
) in the body of the page.
 Other Information: Shows the name of the current Study or Site, start and end date of the
Study, the name of the Principal Investigator, and the Protocol Verification/IRB Approval Date, if
applicable. Click the Study or Site name to see its details.
 Help: Shows the icons relevant to the current page and describes what each icon means. This
section appears only when icons are used in the body of the page, such as for the Subject
Matrix.
3.3.4 Main Body
The Main Body of the Home page is identical for all user roles. It contains interactive dashboards for the
current Study or Site, showing statistics such as: My Discrepancies, Event Status by Events, Events Status
Summary, and Subject Status Summary.
 My Discrepancies: Provides a graphical presentation of the number of new, updated, and closed
discrepancies for the current Study or Site.
 Event Status by Events: Displays a graphical summary of Events for the current Study or Site,
reporting the progress that has been made within each Event. Event progress is described in
percentages using a stacked bar graph, with the corresponding Event Statuses shown in
different colors.
 Events Status Summary: Presents a summary of the Status of Events in the Study as a pie chart
with the percentage of Events at a given Status in the Study.
 Subject Status Summary: Presents a summary of the status of Subjects in the Study as a pie
chart with the percentage of Subjects that are available, signed, removed, and locked.
The Customize Home Page button at the bottom of the page allows users to change the Home page
layout via a drag and drop action.
3.3.5 Home Page Footer
The Home page footer is the bottom area, just below the Main Body. It shows the current ClinCapture
version number.
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3.4 Last Row Accessed
As you perform actions in ClinCapture, the system remembers your last row accessed and highlights that
row in orange. Even if you navigate away from a page, and then return to that page within the current
session, the last row accessed will still be highlighted in orange.
This feature is provided throughout all tables in ClinCapture.
For example, in the following image, the last action taken on the Subject Matrix page was for Subject ID
S01-004, so that row is highlighted in orange.
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4 SUBMIT DATA
The ClinCapture Submit Data tasks allow users to track Subjects in the current Study, add new Subjects
to the Study, view and schedule Events, enter and change information about Subjects and Events, create
Notes & Discrepancies, and import data. To access the Submit Data features from the Navigation Bar,
select Tasks, and select the feature you want to use.
Consult the Glossary for a full description of terms used in this chapter.
4.1 Subject Matrix
To access the Subject Matrix, click the Subject Matrix link in the Navigation Bar.
The Subject Matrix page contains the Event information for all Subjects within your current scope: Site
or Study. You can perform any action appropriate and allowable to your role, including viewing and
entering information, performing Source Data Verification (SDV), and signing CRFs for Study Events and
Subjects.
Each row contains one Subject. The first column is the Study Subject ID, the last column contains the
available actions for the Subject, and the other columns are for each Event Definition in the Study. Each
cell in the matrix contains an icon that describes the status of the Event for the Study Subject. The Event
Status is a composite of the CRF’s status and requirements configuration designed to bring your
attention to the next logical task for an event. This is explained in greater details in Event Status.
When the current scope is set to the Study level, the matrix shows all Subjects in the Study. When the
current scope is set to a Site, the matrix shows only Subjects at that Site. See Changing the Current
Scope for details.
4.1.1 Subject Matrix Pop-up
If you place your cursor over an Event status icon, a pop-up appears after a short delay. For a faster
reaction, click the icon. The pop-up remains visible if you click inside it—a move that gives you additional
time to scroll or adjust the window. The pop-up disappears if you click anywhere outside of it.
If you place your cursor over an unscheduled Event, the following Pop-Up appears:
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Figure 8: Scheduling an Event using the pop-up
Note: The pop-up appears differently from time to time because the fields inside it are configurable.
For instance, your Study may require collection of the location and the end date.
If you place your cursor over a scheduled Event, the pop-up contains the Action icons that are valid for,
and related to, your role, and appropriate for the current status of the Subject, Event, and CRFs.
You can also skip the event scheduling altogether and start collecting data right away by clicking on Start
Data Entry. In this case, the View Event page appears allowing you to enter data in any CRF related to
this study event.
Figure 9: View Event page
After an event is scheduled, if you position your pointer over the status icon, a Scheduled Event pop-up
appears.
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Figure 10: Sample Scheduled Event pop-up
The icons in the first row are for actions valid for the Subject. Depending on your role and the status of
the CRFs, you can Edit, View, Remove, SDV, Sign, or Re-Assign a Subject.
The icons in the second row relate to actions affecting the Event. Depending on your role and the status
of the CRFs, various actions can be effected, such as: Edit, View, Remove, SDV, or Sign an Event.
Starting with the third row, the action icons relate to managing the CRFs. Depending on your role,
various actions can be taken, such as Edit, View, Enter data, Print, Remove, or Delete a CRF.
The orange asterisk (*) at the end of a CRF name indicates that data must be submitted to the CRF.
The green check mark () indicates that a full or partial SDV must be performed after data collection has
been completed.
4.1.2 Subject Matrix Pop-up Action Icons
In the Subject Matrix pop-up, click the action icon to operate on the Subject, the Event, or CRF. The
icons that appear depend on the status of the Subject, the Event, the CRFs, and your user role.
Icon
Meaning
Description
Edit
Edit or modify an object such as a Subject or an Event.
Enter Data
Allows users to enter data into a CRF.
View
Displays information on an object such as a Subject, an Event, a Site or a CRF.
SDV
Allows a Study or Site Monitor to verify the data was correctly entered and
submitted. SDV can be performed by CRF, Event, or by Subject.
Sign
Allows an Investigator to sign the entire Subject’s casebook or an Event.
Remove
Removes an object such as a Subject, an Event, a Site from the Study or Site. You
can restore these objects to the Study or Site later.
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Restore
Restores an object that was previously removed. Restore brings back the object
into the Study or the Site without data loss.
Delete
Allows a Study Administrator to permanently delete an object, such as a CRF.
Reassign Study Allows a Study Administrator to reassign a Study Subject to a different Site in
Subject
the Study.
Print
Print an object such as a CRF or a Note & Discrepancy.
4.1.3 Adding a Subject
Investigator and CRC users can add new Subjects. To add a Subject to a Study, click the Add Subject link
in the Navigation Bar (or select Tasks > Add Subject). See Add Subject for more details.
Note: To work with a Subject across multiple Studies, or to change information about a Subject that
cannot be changed using the Submit Data module, request help from your Study Administrator.
These topics are covered in detail in the ClinCapture Administrator’s Guide.
4.1.4 Scheduling a Subject
Before you can enter data, you must schedule a Subject for an Event. To schedule a Subject for an Event,
click or position your pointer over the Event you want to schedule to display the Scheduled Study Event
pop-up (see Figure 8).
You can schedule a Subject for up to five events at a time. When ready to schedule the Events and
return to the Subject Matrix, click Schedule Event.
Optionally, to start capturing data for the scheduled Events, click Start Data Entry.
To dismiss the pop-up without making any changes, click Cancel.
4.1.5 Locking or Unlocking a Subject Record
A Study Administrator can lock or unlock the entire casebook for a Subject. The Lock icon appears in the
Subject Matrix when a Subject is scheduled for their first event. See User Roles for details.
Icon
Meaning
Description
Lock
Lock a Subject casebook.
Unlock
Unlock a Subject casebook.
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Figure 11: Lock/Unlock Subject icons in Subject Matrix
If Notes & Discrepancies exist for the Subject, you can view the data in the CRF, and access and resolve
the Notes & Discrepancies. However, the CRF data cannot be changed.
Note: You can also lock data at the Site and Study levels. See the ClinCapture Administrator’s Guide for
details.
4.1.6 Dynamic Groups
In ClinCapture, you can associate specific Study Events with a Dynamic Group. For example, to create
multiple treatment arms, different Dynamic Groups can be configured with different Study Events.
Dynamic Groups include the following features:
 The Dynamic Group name is located just above its associated Event names. In Figure 12, the
Dynamic Group names are Screening, Radio Therapy, and Surgery.
 You can define a default Dynamic Group that is automatically assigned to a new Subject. In
Figure 12, Screening is the default Dynamic Group.
 To avoid confusion while scheduling Study Events, the icons representing the Study Events state
are not visible in the Subject Matrix until the Subject is assigned to that Dynamic Group. In
Figure 12, no Subjects have been assigned to the Radio Therapy Dynamic Group.
 Dynamic Groups can work in conjunction with the randomization function to automatically
assign a randomized Subject to a Dynamic Group. See Subject Randomization for more details.
 Users have the option to manually set or override Dynamic Group assignments. See Editing
Study-specific Information for instructions.
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Figure 12: Dynamic Groups in a Subject Matrix
4.1.7 Submitting Data for a Subject
You can submit data for a Subject after they are added and scheduled for an Event. Click the desired
event to bring up the applicable pop-up, and click the Enter Data icon for the CRF you want to submit
data.
4.1.8 Show More Subject Information
To see more information about Subjects in the Subject Matrix, click Show More. The matrix widens to
add the Date Created, Subject Status, and Site ID.
Note: Field names may be configured differently to meet your protocol specification.
When the Subject Matrix is expanded, click Hide to stop showing the additional columns.
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Figure 13: Show More Subject Information
4.1.9 Finding and Organizing Data
The Subject Matrix has the following features to help you find and organize data for the Study Subjects.
Number of Subjects per Page
The bottom left corner shows the total number of Subjects and the number currently in view. When
there are more Subjects in the Study than can be listed on the page, use the green arrows to scroll
through the pages of Subjects.
When there is only one page of Subjects, the arrows are disabled (gray). To change the number of
Subjects shown on a page, click the drop-down list next to the arrows and select a value: 15, 25, or 50
per page.
Sort Data by Column
By default, the Subject Matrix is sorted by Subject ID, in descending order with the last entered Subject
first. To sort the data by a column, click the column header. Some columns do not allow sorting by, in
which case, the pointer does not change shape when you position it over the column header. To reverse
the sort order, click the column header again. An arrow next to the column header indicates the current
sort order: up for ascending and down for descending.
For example, in Figure 13 the Subject Matrix is sorted by the Date Created column in descending order.
Filter Data to Show Only Matches for Specified Criteria
You can filter the information shown in the Subject Matrix to show only Subjects whose data match the
criteria you specify. You can specify the criteria for one Event column, and any of the other columns.
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 For the column whose data you want to filter, click the gray field below the column header.
 If a drop-down list displays, select the value you want to use as the filter. If no list displays, type
in the string of characters you want to include, and press Enter or click Apply Filter (located to
the far right of the gray fields).
For instance, you can type 003 in the gray field below the Subject ID, indicating that you want a
list of Subjects with Subject ID containing 003, and click Apply Filter.
You can add more filters, if necessary.
To remove filtering for a column, clear the text you entered, or from a drop-down list, select the blank
(top) item.
When filtering is applied, the Subject Matrix shows only those Subjects that contain the data you
specified. To clear all filtering and show all data, click Clear Filter (located to the far right of the gray
fields).
Figure 14: Subject Matrix filtered by Subject ID
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Figure 15: Subject Matrix with multiple filters
4.1.10View Event Details
To view the details of a Study Event from within the Subject Matrix, bring up the pop-up and click the
View icon for the Event.
Figure 16: View Event icon in Event Details pop-up
4.1.11Study Subject Record
To view the details of a Subject from within the Subject Matrix, bring up the pop-up. Click the Edit icon
to modify the Subject record, or click the View icon to display the Subject record.
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Figure 17: Edit Subject and View Subject icons in Event Details pop-up
The View Subject page contains all study information for the selected Subject in the following sections:
Study Subject Record, Subject Casebook, and Events.
Figure 18: View Subject Record page
By default, the Events section is expanded. Click the plus or minus sign next to a section to show or hide
information in that section.
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The following buttons may appear at the bottom of the page:
 Subject’s Discrepancies: View all Notes & Discrepancies related to this Subject.
 Subject’s Audit Log: View all captured transactions for the Subject.
Study Subject Record Section
The Study Subject Record section contains general information on the Subject, including Status, Person
ID, and Date of Birth.
Figure 19: Study Subject Record section
To change the Study Subject information, click the Edit icon to open the Update Study Subject Details
page, where you can edit global information, such as the Subject ID, Person ID, and group assignments.
You can also lock all data for a subject by clicking on the Lock icon.
Figure 20: Update Study Subject Details page
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Subject Casebook Section
View all CRF data collected for the subject so far.
Note: If CRF masking functionality is being used, the CRFs that have been masked from you will not
display on the subject casebook.
Figure 21: Subject Casebook section
To view the subject casebook:
1. Select the casebook format.




Printable HTML
Printable PDF
JSON
CDISC ODM XML
2. Select the option(s).


Notes & Discrepancies – Select to include the subject’s Notes & Discrepancies in the
casebook.
Audit Trail – Select to include the subject’s Audit Trail in the casebook.
3. Click Open.
The subject casebook opens in the selected format. You can use your browser’s print feature to
print the casebook.
Note: Depending on the size of your data, it may take several minutes to generate the
casebook.
To generate a link to the subject’s casebook:
1. Click Get Link.
2. Copy the displayed URL to link to or bookmark the subject casebook.
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Events Section
The Events section shows information about all the events currently in progress for a Study Subject.
Figure 22: Events section
To search for Events by name or location, enter the value you are looking for in the text box, and click
Find.
Each row shows details for a specific Event, including:





Start Date
Location
Status
Actions, represented by icons that you can click for the Event
CRFs for the Event
For each CRF in the Event, the following information is available:





Name
Version
Status, represented by icons
Updated, indicates the date when the CRF was last updated and who made the changes
Actions, represented by icons that you can click to perform operations on the CRF
You can remove a CRF for a Subject, and the CRF is marked as Removed. You can restore a CRF that has
been removed without losing data; however, the CRF status will be Initial Data Entry Started. You must
re-inspect the data and mark the CRF complete again.
For more details about editing a CRF, see Entering CRF Data.
By default, Events are ordered by Start Date, with the most recent Start Date first. Click a column header
to order the Events by that column. Click again in that column to reverse the sorting order.
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4.2 Add Subject
When you add a Subject to a Study or Site, you create a Study Subject record and schedule one or more
Events for the Subject. There are two ways to add a Subject to a Study or Site:
 From the Subject Matrix: Use to add a Subject and schedule the first Event.
 From the Tasks menu: Use to add multiple Subjects or schedule multiple Events.
Before you can add a Subject to a Study or Site, the Study or Site must exist and the Study status must
be available. See your Study Administrator if you do not see the Add Subject link in the Navigation Bar.
The CRC and Investigator user roles can add Subjects to their current Site, although the Study
Administrator can later change the assignment.
After adding a Subject, you can edit the information in the Subject record from the Subject Matrix. See
Study Subject Record.
4.2.1 Add Subject from Subject Matrix
Perform the following steps to add more than one Subject and schedule them for a Study Event:
3. In the Subject Matrix, click the Add New Subject link. The Add New Subject page opens.
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4. Complete the information on the page as described in the following steps. Some of the
information might be different or optional for your Study. For a description of the terms, see the
Glossary.
Note: An asterisk (*) indicates a required field.
a. Enter the Study Subject ID.
Depending on your Study Parameter Configurations, the Study Subject ID may be:

Entered manually

Automatically generated, but you can edit it

Automatically generated, but you can not edit it
b. Enter the Secondary ID. This is another identifier for the Subject. This field may be labeled
differently or be hidden.
c. Enter the Enrollment Date in the specified format, or click the Calendar icon to select it. This
field may be labeled differently or be hidden.
d. Select the Sex. This field may be labeled differently or be hidden.
e. Enter the Date of Birth in the specified format, or click the Calendar icon to select it. This
field may be labeled differently or be hidden.
f.
Select the Group(s) from the drop-down list, if any Subject Group Classes were defined in
the Study setup.
g. Select the first Study Event from the drop-down list.
h. Enter the Start Date for the Event, or click the Calendar icon to select it.
The following buttons are available at the bottom of the page:
 Back: Subject data entered is not saved and takes you back to the Home Page.
 Submit: Saves the Subject you just created and takes you to the Subject Matrix.
 Start Data Entry: Saves the Subject you just created and allows you to enter data for the given
Study Event.
 Schedule Events: Saves the Subject you just created and allows you to schedule the Study
Events.
 Add Next Subject: Saves the Subject you just created and opens a new Add New Subject page
where you can add another one.
 Cancel: Cancels the operation and takes you back to the Subject Matrix.
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4.2.2 Add Subject from Tasks Menu
To add Subjects from the Task menu, select Tasks > Add Subject, and follow the same steps outlined in
Add Subject from Subject Matrix.
4.2.3 Assign or Reassign Subject to Site
When you add a Subject, the Subject is added to the current Study or Site. Typically, you set the current
Site and add Subjects to that Site. However, you can add a Subject to the overall Study and later assign
the Subject to a Site. You can also change a Subject’s assigned Site.
The Site to which a Subject is assigned is reported in the Study Subject Record. You can also see the Site
assignment in the Subject Matrix. When the current Study or Site is set to the Site level, the Subject
Matrix shows only the Subjects assigned to that Site, so any Subject shown in the matrix is assigned to
the current Site. When the current Study or Site is set to the Study level, click the Show More link to
view the Site assignments in the Subject Matrix.
A Study Administrator can assign a Subject to a Site, or reassign a Subject to a different Site from the
Subject Matrix using the following steps:
1. Change your current scope to the appropriate Study, if needed.
2. Locate the Subject in the Subject Matrix.
3. In the Actions column for the Subject, click the Reassign icon. The Reassign Study Subject page
opens, with the Subject's current assignment selected.
4. Select the Site to which you want to assign the Subject, and click Continue. The Confirm
Reassign Subject page opens.
5. Click Submit.
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4.2.4 Add a Subject to Multiple Studies
After adding a Subject to a Study in ClinCapture, the Subject can participate in other ClinCapture Studies.
Simply add the Subject to each Study, using the same Person ID. When you add a Subject to a second or
subsequent Study, ClinCapture presents you with a confirmation screen, and ensures that the Sex and
Date of Birth for that Subject match the values already in the database for the same Subject.
Note: A Subject cannot be added to multiple Sites within the same study.
4.3 Edit Subject
A Subject is associated with two types of information:
 Global information: Information that is person-related and can be used across multiple studies.
For example, date of birth or gender.
 Study-specific information: Information that is specific to a study. For example, date of Study
enrollment or group assignment.
You can edit both global and study-specific information.
4.3.1 Editing Global Information
Administrator users can edit the following global information from the Administration Module. For user
type and role descriptions, see User Types and User Roles.
 Person ID
 Sex
 Date of Birth
To edit global Subject information:
1. Click Tasks > Subjects then on the Edit icon for the desired Subject..
The Update Subject Details page opens.
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2. Make the necessary changes, and click Continue.
3. Click Submit to confirm your changes.
4.3.2 Editing Study-specific Information
The following study-specific Subject information can be edited:





Study Subject ID: The unique Subject ID in the Study.
Secondary ID: Optional secondary ID, used for example to associate Subject with a Lab ID.
Date of Enrollment: Date the Subject was enrolled in the Study.
Subject Group Class: Cohort group, such as Arm, Demographics, etc.
Dynamic Group Class: See Dynamic Groups for details.
To edit the Study-specific information for a Subject:
1. Open the Subject Matrix.
2. Hold your pointer over, or click on the Study Event, to display the pop-up.
3. Click the Edit icon on the Subject row.
The Update Study Subject Details page appears.
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4. Edit the necessary information, and click Continue.
5. Click Submit to confirm your changes.
4.4 Schedule Event
Study Events have a type, date, status, and associated package of CRFs. In ClinCapture, a Study Event is
also referred to as an Event.
Each Event is assigned an Event Definition, for example, Registration Visit. An Event can be repeating
(occurs more than once) or non-repeating (occurs only once). You can configure a Study Event in the
following different ways:
 Scheduled Study Event: When CRFs are expected for each Subject as part of the planned
sequence for the Study.
 Unscheduled Study Event: When CRFs are designed to collect data that might or might not
occur for any Subject, such as early termination due to a serious adverse event.
 Common Study Event: When CRFs are used for more than one different Event, such as a
Concomitant Medications Log.
4.4.1 Scheduling a Study Event
Before you can schedule a Study Event for a Subject, the Subject must be added.
You can schedule a Study Event from the Event pop-up or the Tasks menu.
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Using the Event pop-up
To schedule a Study Event using the Event pop-up:
1. Position your pointer over, or click, the Event that you want to schedule. The Event pop-up
appears which allows you to schedule an Event right from the Subject Matrix.
2. The actions that you can take depend on the Event repeating type:
a. Non-repeating Event: Click the Not Scheduled icon, and follow the steps detailed in
Scheduling a Subject.
b. Repeating Event: Click the Event to show the number of Event occurrences that have
already been scheduled or completed. To add a new Event, click the Add Another
Occurrence link in the pop-up window.
Using the Tasks menu
To schedule a Study Event using the Tasks menu:
1. In the Navigation Bar, select Tasks > Schedule Event.
2. Enter the Study Subject ID. The Schedule Study Event page opens.
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3. Enter the information in the Schedule Study Event page. If you need to enter dates, either type
them in the field in the correct format, or click the calendar icon to select them. The End Date is
optional: keep it empty if it does not apply. Keep in mind that the Event Scheduling panel may
be different than shown above, as it can be configured to meet the requirements of your Study
Protocol.
4. After you complete the scheduling the information, you can schedule another Event.
5. After entering information for all Events that you want to schedule, click Start Data Entry to
proceed to the View Event page where you will be able to submit data.
6. If you do not want to enter data about the Event until later, click Cancel.
4.5 Calendared Event
A Calendared Event can be automatically scheduled when a reference visit is completed. This is typically
used for follow-up events that must occur within a predefined period of time after the treatment
occurred.
When a reference visit completes, Calendared Events are automatically scheduled and a Calendar icon
appears on the subject Matrix.
Figure 23: Calendar Icon in Subject Matrix
Click the Calendar icon to open a pop-up window with the scheduling details for the Calendared Events.
All column headers are sortable.
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Figure 24: Sample Calendared Events Parameters details
A Calendared Event must be completed within a minimum and maximum date range. In Figure 24, the 1
Month Follow-up is scheduled for 09-Apr-2014, and must be completed no sooner than 05-Apr-2014
and no later than 15-Apr-2014. If a Calendared Event is not completed as expected:
 An automatic query is generated by the system.
 The Calendar icon on the Subject Matrix turns red until the discrepancy is resolved.
A reminder email can be sent to any user in the Study before the Calendared Event occurs. In the
example above, the reminder email will be sent on 8-Apr-2014 for the 1 Month Follow-up event.
When all the Calendared Events are completed and the queries, if any, closed, the Calendar icon is no
longer displayed in the Subject Matrix.
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Note: Calendared events inside a dynamic group that is not assigned when the reference event
completes will not be automatically scheduled. That is because the events inside the dynamic
groups are not assigned and thus cannot be calendared.
4.6 View and Update Events
4.6.1 Viewing Events
The View All Events page contains information for each Event Definition that matches specific criteria.
The Event name and type, and Subject status (Scheduled, Completed, and Discontinued) are shown
above each table.
By default, Events in the table are sorted by date, with the most recent Event shown first. To change the
sort order, click the header of the column you want to sort by. To reverse the sort order, click the
column header again. An arrow indicates the order as ascending (up) or descending (down).
To find an Event within a table, type a string of characters in the find box, then click Find. ClinCapture
finds matching strings in the Study Subject IDs or in Subject Event Status fields, and shows only those
Events that match the criteria. To reset the table and show all Events, click Clear Search Keywords, next
to the Find button. You can view the details of an Event or edit the Event by clicking the View or Edit
icons in the Actions column.
Yellow highlighting of a row indicates that the Event Scheduled Date has passed and data entry has not
been started.
You can view information about all Events, or show only the Events that match specific criteria.
To open the View All Events page:
1. In the Navigation Bar, select Tasks > View Events. The View All Events page opens for the
current Study or Site, presenting a filter.
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2. Specify the criteria for the Events that you want to view. For example, specify Enrollment as the
Study Event Definition, data entry started as the Status, and that it occurred between 01-Jan2012 and 01-Jan-2013.
3. Click Apply Filter. ClinCapture displays all Events that match your criteria in a series of tables,
with one table of results for each Event Definition. To print the results, click the Print icon at the
top of the page.
4.6.2 Updating Events
You can update information for an Event, such as the date or status. There are several ways to change
Event information. The fastest way is described below:
1. From the Event pop-up, click the Edit icon on the Event row.
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The Update Study Event page opens.
2. Make your changes. If you are changing the Event status, you are presented only with
appropriate and allowable options, given your User role, the Study status, and the status of the
CRFs for the Event. For more information, see Event Status.
3. Click Submit.
For example, you can change the Status to Stopped, and click Submit. The View Subject page opens,
showing the updated information for the Event.
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4.6.3 Event Status
You can manually update the Event Status as described in Updating Events. ClinCapture automatically
updates some conditions. There are different ways to view the Study Events status:
 Use the Event View to see all Events that match the criteria that you specify, see Viewing Events.
 The Subject Matrix icon shows the status of each Event for each Subject.
These are the different Study Events status values and a description of how the status changes:
Icon
Meaning
Description
Not Scheduled
After a Subject is added to a Study, but before an Event is
scheduled. For certain Events, like Adverse Events, the Event
Status might remain in this state throughout the entire Study.
Scheduled
After a Subject has been scheduled for an Event. This is
automatically set.
Data Entry Started
After a Subject is scheduled for an Event, and any CRF for that
Event is opened, the Event Status is automatically set to Data
Entry Started. The Data Entry Started status applies even if you
did not actually enter data.
If you inadvertently open a CRF but do not save the data, you will
not be able to change the Status of the CRF or Event. To change
the Status, you must delete the Event CRF, or the Event for that
Subject, and restore it when you are ready to enter data.
An Event stays in Data Entry Started until all required CRFs are
completed.
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Stopped
When a Subject has temporarily stopped participating in a Study.
Skipped
When a Subject does not complete an Event.
Completed
After the Status of all required CRFs (and non-required CRFs, if
data entry has started) for an Event are marked complete. This is
automatically set.
If you make any changes to a CRF after an Event has been
completed, the Status of the CRF and the Event remain
completed. You might need to complete a Reason For Change
Discrepancy Note, depending on your system’s configuration.
You can manually set the Event status back to Data Entry Started,
and then again back to Completed, as needed.
Initial Data Entry Completed
If the CRFs are configured for Double Data Entry or CRF
Evaluation, this indicates that the CRFs have been marked
complete after the initial data entry and are ready for Double
Data Entry or CRF Evaluation.
Coded
The item has been coded.
Not Coded
The item has not been coded.
Source Data Validated (SDV)
After all the completed CRFs with full or partial SDV
requirements have been validated. This is automatically set.
Signed
When all the CRFs for an Event have a status of Completed or
Not Scheduled. When you sign the casebook for a Subject,
ClinCapture automatically sets the status to Signed for all Study
Events for that Subject. After an Event Status is signed, any
changes to the CRF automatically change the Event Status to
Completed.
Locked
When you no longer want Users to be able to enter or change
data for an Event.
Note that you can set the Status of a Study to Frozen or Locked
to prevent prospective users from changing the data; however,
doing so does not change the Status of any Event in the Study.
Removed
When an event has been removed.
4.6.4 Electronic Signatures
If your user role has appropriate permissions, you can sign a Study Event or an entire casebook for a
Subject. The ClinCapture electronic signature process complies with the FDA Code of Federal
Regulations (CFR) Title 21 Part 11.
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Signing an Event
When you sign an Event, you signify your approval of all CRF data in the Event for the Subject.
1. To sign an Event, place your pointer over the Event you want to sign, and click the Sign icon in
the pop-up.
Note: You can also sign an Event by setting the Status to Signed while performing an Event
update, see Updating Events.
2. The Sign Study Event page opens and displays information on the Event, the Study Subject, and
the implication of signing the Subject’s record. Review the collected information as necessary.
3. Enter your username and password in the appropriate fields.
4. Click Sign.
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The View Subject page opens and shows the Status of the Event as signed.
Note: If, in ClinCapture Builder, a CRF within the event was defined to send an email upon signature,
an email will be sent to the address specified for the CRF when the event containing the CRF is
signed.
Signing a Casebook
When you sign a Subject’s casebook (complete Subject Record), you indicate your approval of all CRF
data in all Study Events for the Subject.
The following requirements must be met before you can sign a casebook:
 No Events for that Subject can have a status of Scheduled or Data Entry Started.
 All CRFs that require SDV must be source data verified.
 No discrepancy or query can be opened.
The Sign icon appears in the Actions column in the pop-up or Subject Matrix for all Subjects that meet
these requirements.
To sign a Subject casebook:
1. Click the Sign icon in the pop-up or Subject Matrix.
The Sign Subject page opens. The investigator can review the entire subject’s record by clicking
the View Subject’s Record button. This page presents a statement about what signing the
Subject Record signifies or means.
2. Enter your username and password in the appropriate fields.
3. Click Sign Casebook.
The Subject Matrix opens and shows the Status for all Events as signed.
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Note: If a CRF within the event was defined to send an email upon signature, an email will be sent to
the address specified for the CRF when the event containing the CRF is signed.
4.7 Entering CRF Data
In ClinCapture, users supply Event information for a given Subject using Case Report Forms (CRFs).
ClinCapture provides the following options to enter data in a CRF:
 Manual Data Entry: Manual data entry using the ClinCapture web-based interface, see Manual
Data Entry. ClinCapture prevents multiple users from inadvertently entering data in the same
CRF at the same time, by making the CRF unavailable, see CRF Unavailable. An option for double
data entry is available to help ensure the integrity of the data during the data entry process, see
Double Data Entry.
 File Import: Import CRF data from a file into ClinCapture for one or more Events. The import can
occur once, or can be scheduled as a recurring job. See Importing CRF Data for more
information.
 Import using Web Services: Import CRF data using SOAP Web Services. Refer to the ClinCapture
Programmer’s Guide for details.
4.7.1 Manual Data Entry
To manually enter data into a CRF:
1. Open the CRF from the Subject Matrix or View Events page.


In the Subject Matrix, place your pointer over or click on a particular Subject and Event
where you want to submit data. In the pop-up, click the Enter Data icon for the desired CRF.
This is the fastest way to enter data.
In the View Events page, click the Enter Data icon for the desired Event.
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The View Events page can be opened in the following three ways:



After you schedule an Event, click the Submit button on the Schedule Study Event page.
Open the pop-up for an unscheduled Event on the Subject matrix, and click Proceed to
Enter Data.
Click Tasks > View Events. If needed, apply a filter to target the Study Events, and click
the View icon for the desired Subject.
The orange asterisk (*) at the end of a CRF name indicates that data must be submitted to the
CRF. The green check mark () indicates that a full or partial SDV must be performed after data
collection has been completed.
2. If multiple versions of the CRF exist, select the one you want from the drop-down list in the
Version column before clicking on any action icons (Edit, View or Print).
3. If you want to print the CRF, click the Print icon for that CRF. The printout includes all data that
has already been entered in the CRF. To view a read-only version of the CRF, click the View icon.
Note: When a CRF is viewed or printed in this manner, the skip logic cannot be triggered, and
therefore, all hidden fields appear.
4. The first page of the CRF opens. In the example below, the CRF page is: Inclusion / Exclusion.
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Click the More Info link to open the CRF Header and view additional information, such as the
Interviewer’s Name and Interview Date, if your study is configured to collect this information.
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If notes or discrepancies exist in the CRF, the CRF Shortcuts panel will be displayed. Sometimes
CRFs are quite long and discrepancy notes may not be readily apparent. The counters in the
Discrepancy Notes section of the CRF Header are shortcuts that can quickly take you to each
occurrence of the item in the CRF. Click the counter once to go directly to the first occurrence.
Continue to click the counter to advance to each subsequent occurrence.
For example, in the following Discrepancy Notes image, clicking the 2 in the New Discrepancies
column will advance to the first new discrepancy in the CRF and highlight the associated field.
Clicking 2 again will advance to the next new discrepancy in the CRF.
The title of the CRF Page is listed in a tab above the form. To select a different page, click the tab
for that Page.
5. Enter the information for the current Page. The icon changes from
page now contains unsaved data.
to
indicating that the
6. In the tab next to the Page title there are two numbers in parenthesis. The first number
indicates the number of items entered in the Page. The second number indicates the total
number of items in the Page. For example, (0/5) indicates that there are 5 items in the Page, and
that no data has been entered in any of them yet.
Instructions for completing each item in a Page are shown at the top of the page or with each
item.
If you need to enter a value that differs from what is expected, or need to annotate a data point,
you can add a Discrepancy Note by clicking the Add Discrepancy Note ( ) icon for the item and
entering the note. For details, see Notes and Discrepancies.
7. After completing a CRF Page:
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a. If you don't want to save the information you entered for a Page, click Exit to end data
entry, or click on another Page tab. The system warns you about losing your unsaved data.
b. If you want to keep the information you entered for that Page, click Save.
c. If there are problems with the data that you entered, ClinCapture does not save the data
and displays messages concerning the information that is incorrect.
d. ClinCapture checks that all required values are provided and that the values entered comply
with the field validation checks and rules that are defined for the CRF.

A validation check message reported in red font indicates a Hard Validation Check that
must be fixed or a discrepancy note must be provided before you can save the data. For
example, if you entered text in a numerical field, or a date is not correctly formatted.

A validation check message reported in orange font indicates a Soft Validation Check.
Soft Validation Checks occur when CRF data passes the Hard Validation Checks but its
content fails to follow a Rule. For example, a person’s weight is expected to be less than
350 lbs.
Two options are available to process a Soft Validation Check:

Option 1: Override the validation check by clicking Save again. The system will
automatically generate a Failed Validation Check Note. For details, see Discrepancy
Note Types

Option 2: Annotate the discrepant data, and click Save again.
Correct all data entry errors or provide Discrepancy Notes for them, and click Save.
e. Upon saving a Page, ClinCapture performs any necessary calculations specific for that Page,
and displays the next Page in the CRF, if any.
Complete and save all Pages in the CRF.
8. In the last CRF Page:
a. If all information has not been entered, do not select Mark CRF Complete; you can return to
edit the CRF later to complete the information and mark the CRF Complete at that time.
b. After all information has been entered in the CRF, select the Mark CRF Complete checkbox,
and click OK in the confirmation dialog box.
c. Click Save in the last Page.
i.
If a password is required, supply your password in the dialog box that opens.
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ii. If double data entry is required for the CRF, the CRF must be re-entered by another
user.
iii. If CRF evaluation is required for the CRF, the study evaluator will be able to evaluate the
data, and change it if necessary.
d. The View Event page opens, and the Status for the CRF will be:
i.
Initial Data Entry Complete - If the next step is double data entry or CRF evaluation and
the CRF has been marked Complete.
ii. Data Entry Complete - If the data is ready to be submitted to the Monitor or
Investigator and the CRF has been marked Complete.
iii. Data Entry Started - If you did not mark the CRF Complete.
Note: If the CRF was defined to send an email upon completion, an email will be sent to the
address specified for the CRF when the CRF is marked complete.
4.7.2 Subject Randomization
ClinCapture is integrated with a randomization module from randomize.net. This module offers block
randomization, which differs from simple randomization in that it’s designed to randomize Subjects into
groups that result in equal sample sizes. This method ensures a balance in sample size across groups
over time.
To ensure privacy and security, all communication between ClinCapture and randomize.net is encrypted.
ClinCapture supports stratified randomization, which addresses the need to control and balance the
influence of covariates (baseline patient characteristics). Stratified randomization balances the control
and treatment groups for age or other identified covariates.
Single- and double-blinded randomization methods are supported.
Any stratification variable can be captured and controlled in the randomization CRF, including
demographics and eligibility criteria.
After randomization is configured and activated by your Study Administrator, Subjects can be
randomized as follows:
1. Subjects are randomized within their specific site. Make sure your current scope is set to the
proper site. See Changing the Current Scope for details. Failure to set your scope properly may
result in the following error.
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2. Consult your CRF Completion Guidelines to locate the randomization CRF. Open it for data entry.
3. Enter data on the randomization CRF, including the stratification variables required to
randomize the subject.
4. Click the Randomize Subject button once. The button is greyed-out until the randomization
results are displayed.
5. When the randomization result is available, it is immediately saved to the database, along with
the stratification variables, even before the CRF is saved. This is to avoid losing the
randomization result because the CRF is not saved. Click OK to dismiss the alert message.
6. If the randomization result matches the name of a Dynamic Group, the Subject is automatically
assigned to that Dynamic Group.
7. Check the Mark CRF Complete box, and click Save to end the randomization process and save
the CRF data.
Note: Subjects can be randomized only once. If a Subject was incorrectly randomized, for example, it
was randomized with incorrect stratification variables, or if the randomization CRF was deleted,
you must contact your Study Administrator to correct the situation. They may have to contact
randomize.net to undo the previous randomization before you can try again.
Note: Upon successful randomization, Subjects are assigned a randomization number. If the
randomization parameter, Assign Randomization Parameters to, under Study Parameters is set
to Study Subject ID, the randomization number becomes the Subject’s Study Subject ID,
replacing the existing SSID.
For example, prior to randomization, a Subject’s SSID is S01-103. After this subject is
randomized, the system generates a randomization number of 1048. The Subject’s SSID is
changed to 1048.
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Figure 25: Subject Randomization CRF
4.7.3 CRF Unavailable
ClinCapture prevents multiple users from entering data in, or editing, a CRF at the same time. If you try
to enter data in, or edit, a CRF that another user is already working on, ClinCapture displays a message
that the CRF is unavailable for data entry. The message also indicates who is currently editing the CRF.
You won’t be able to edit an open CRF until the other user closes the CRF.
4.7.4 Double Data Entry
Double Data Entry requires that data intended for a particular CRF must be entered twice to ensure the
integrity of the captured data. It is typically used when CRF data is first captured on paper forms, and
then entered into the ClinCapture system. Double Data Entry can be classified as either optional or
required, depending on the specification defined and fully described in the Study Event Definition for
each CRF.
During Double Data Entry, ClinCapture detects discrepancies between the values in the initial data entry
and the second data entry, and provides options for resolving the discrepancies.
There are options for who can perform the Double Data Entry, and when:
 After a user completes entering the initial CRF data, a different user can perform the double
entry.
 The user who initially enters the data can also perform the double entry, provided that twelve
hours have elapsed since the initial data entry was done.
 Certain user roles have permission to complete initial data entry and move directly to Double
Data Entry without waiting.
Use the following process to complete CRF data entry when using Double Data Entry:
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1. Perform initial data entry for the CRF, mark it complete, and click Save.
2. Perform Double Data Entry for the CRF, mark it complete, and click Save. If any values in the
Double Data Entry are different from the initial data entry, an error message displays. Address
the differences in one of the following ways:



If the value in the Double Data Entry is correct, keep that value by clicking Save again. The
Audit Log stores the user’s name, date, time, and value entered in both the initial data entry
and in Double Data Entry.
If the value in the initial data entry is correct, change the Double Data Entry value to the
correct one in the CRF field, and click Save. The Audit Log stores only the initial value.
If you want to maintain the value from the initial data entry and from the Double Data Entry
for later follow-up, add a Discrepancy Note, and click Save.
4.7.5 CRF Status
The Status of a CRF progresses through the data entry process in the following manner.
Note: Some CRF states, such as SDV, Signed, and Removed, are not discussed here, since they are not
part of the data entry process.
CRF Status
Icon
Description
Not Started
The CRF has not been opened for data entry.
Initial Data Entry
The CRF has been opened for data entry. The user might have
entered some or all of the data into the CRF.
Data Entry Complete
The CRF has been marked complete. All required data has been
entered and saved, and the ClinCapture edit checks have been
performed. This icon appears when the CRF is not configured for
Double Data Entry or CRF Evaluation.
If you make changes to a CRF in this state, the Status remains
complete. If the system is set up to create a Reason For Change
Discrepancy Note, you must fill it out.
Initial Data Entry Complete
If the CRF is configured for Double Data Entry or CRF Evaluation,
this indicates that the CRF has been marked complete after the
initial data entry and is ready for Double Data Entry or CRF
Evaluation.
Double Data Entry Started
A user has opened the CRF for Double Data Entry. The Status of
Double Data Entry for a CRF is shown in the Enter or Validate Data
page, in the CRF’s table.
Double Data Entry or CRF
When the CRF has been marked complete after Double Data Entry
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Evaluation Complete
or CRF Evaluation.
Locked
The ClinCapture system automatically sets the Status of all CRFs
for an Event to locked when you set the Status of the Event to
stopped, skipped, or locked. When locked, you cannot enter data
or make changes to the CRF. To enter or change data in the CRF,
you must change the Status of the CRF by changing the Event
Status, see Updating Events.
4.7.6 Modifying a Previously Saved CRF
You can return to edit a page of a CRF that you (or someone else) had previously saved. The data entry
behavior may be different under certain circumstances, as explained below.
Deletion of Previously Saved Repeating Group Rows
If your form uses repeating groups, you cannot delete previously saved rows from the grid using the
Delete icon at the end of the row. If you need to remove a row, change all values to blank for that row.
New rows can be deleted, provided they have not yet been saved.
This behavior helps ClinCapture maintain an audit trail that allows users to trace back all changes that
have been made in the data and improves the integrity and traceability of the clinical data.
Administrative Editing
Another major difference in behavior is experienced after the CRF has been marked complete, and the
Study has been set up to require a Reason For Change.
When you change data under Administrative Editing, for example adding new rows to a repeating group,
you must enter a discrepancy note indicating the reason for change.
To facilitate changing data under Administrative Editing, the Study Administrator may have preconfigured some reasons. Contact your Study Administrator if additional reason changes are required.
4.8 Importing CRF Data
As an alternative to performing manual data entry, you can import Event CRF data from a file using the
ClinCapture web interface. This import feature is useful when your Study data was captured using a
system other than ClinCapture.
The following items are required to import data in ClinCapture:
 The Study exists
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



Event Definitions for the data being imported exist
Event CRFs for the data being imported must exist
Study Subjects for the data being imported exist
Study Subjects must be scheduled for the Study Events for which the data is being imported
The information in the file can be for one or more Subjects, for one or more Events for each Subject, and
for one or more CRFs for each Event. The type of information for each Subject does not have to be the
same. For example, the file can include two Events, each with a CRF for one Subject, and one Event with
three CRFs for another Subject.
The imported Subject CRF data replaces any data that was already captured for that Subject and that
CRF, unless a specific change is made to a study parameter that allows skipping existing data. The
imported CRF data should contain all data required for the CRF, and should be valid. Automatic checks
for imported data are limited and not as robust as when the data is entered manually in the CRF web
interface. Errors trigger automatic creation of Failed Validation Discrepancy Notes. If there are no errors,
the CRF is automatically marked Complete. Any subsequent changes must be done in Administrative
Editing mode and require a Discrepancy Note if the CRF was set up that way. If there are any calculated
value fields in the CRF, you must either supply the correct data in the import file, or open and save the
CRFs manually to generate them.
The data import file must be a properly-formatted XML file. For details, see Data File Format.
You can automate the data import process, which is particularly useful when you import data files on a
recurring basis.
You can also import data into ClinCapture using SOAP Web Services. Refer to the ClinCapture
Programmer’s Guide for details.
4.8.1 Data Import Options
Some data import options configured during study build may affect the behavior of the system,
including whether or not existing data can be replaced during data import, whether or not a CRF is
marked Complete after data import, etc. Here is the complete list of data import options under Study
Parameters:
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Data Import
Description
Mark imported CRF as
Completed?
Select Yes to mark imported CRFs as Complete, or select No if
imported CRFs should not be marked Initial Data Entry Started.
Auto-schedule event during Select Yes to automatically schedule events during import, or
import?
select No if events should not be manually scheduled before the
import.
Auto-create subject during
import?
Select Yes to automatically create subjects during import, or
select No if subjects should not be manually created before the
import.
Replace existing data during Select Yes to replace existing data during import, or select No if
import?
existing data should be skipped during import.
4.8.2 Data File Import
Users with proper permissions can import data from an XML file using the ClinCapture web interface.
The Study or Site in the import file must be the same as the current Study or Site.
To import data from a file:
1. From the Navigation Bar, select Tasks > Import Data.
The Import CRF Data page opens.
2. Click Browse and locate the XML file that contains the import data, select the file, and click
Open. The file name you selected appears on the page.
3. Click Continue.
ClinCapture validates the XML file. Any validation errors found appear in the Alerts and
Messages section in the Side Panel. Correct the errors and retry the data file import.
When validation errors are found, ClinCapture displays a page summarizing the CRF data being
imported, and the results of the Hard Validation Error Checks, including any error message. For
example, an error is reported if a date format is invalid.
4. When no Hard Validation Errors are found, a page presenting the CRF data being imported,
together with any Soft Validation Error Checks appears. Click Continue.
5. Click OK in the confirmation dialog box to complete the data import.
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The CRF for that Subject now contains the imported data. Depending on the Study
configuration, the CRF is either marked Complete, or left as Data Entry Started.
6. If the CRF contains empty fields for calculated values, manually open the CRF—under
Administrative Editing if the CRF was previously marked Complete—and save each page that
contains the generated values. ClinCapture only calculates the values when you save the page
manually. For details, see Entering CRF Data.
If you have Rules set up, you do not need to manually run them; Rules run automatically when you
import data if the Run ImportDataEntry option is set to true. By default, Rules are not set to run
when you import data. The ImportDataEntry flag must be explicitly turned on to run Rules on import.
4.8.3 Data File Format
To import Event CRF data, generate a properly formatted XML file that contains the data to be imported.
The XML file must include the Subject Identifiers that ClinCapture uses to specifically identify the entities
in the Study. The XML file must be compliant with the Clinical Data Interchange Standards Consortium
Object Data Module (CDISC ODM), version 1.2 or 1.3.
To generate the XML file for importing data:
1. Determine the identifiers for the Subjects, Study, Event Definitions, Forms, Item Groups, and
Items where you want to import data.
2. Generate the import file using the identifiers and the data.
A more detailed discussion on the data file format is available in the ClinCapture Programmer’s Guide.
4.8.4 Data File Validation
When you import a data file, ClinCapture validates the file format and performs validity checking for the
data, and displays any error messages in the Alerts and Messages in the Side Panel. Correct all errors in
the file and retry the import operation again.
ClinCapture performs the following validation on the data import file:
 XML is well-formed against the ODM v1.2 or v1.3.
 The unique Study identifier in the import file matches the current Study in the ClinCapture
session where you want to import the data.
 Study Subject OIDs exist for the current Study.
 Study Event Definition OIDs exist for the current Study.
 OIDs for the CRF versions exist for the Study Event Definition OID.
 Study Subject OIDs are scheduled for the Study Events.
 Data values for the Items comply with the metadata. For example, if the metadata for an Item
calls for a value of 1 or 2, the data value for that Item in your import file must be 1 or 2.
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 Data values are in the correct format. For example, when an integer is required, a decimal value
generates an error.
If your Study is configured to flag errors in edit checks, ClinCapture performs the following edit checks
on the data import file:
 Data is in the correct format. For example, a date that is not in the required DD-MMM-YYYY or
yyyy-mm-dd format generates an error.
 Data values are within the limits specified for CRF Items. For example, when the CRF accepts 90
to 110 degrees for temperature, a value of 111 is not accepted.
 Data values match the acceptable criteria for CRF Items. For example, if a Yes answer is required
for an Item and the value in the import file for that Item is No, a discrepancy note is required.
 Required data fields are not empty.
4.9 Notes and Discrepancies
The Notes and Discrepancies feature enables users to document, communicate, and manage the
accuracy and completeness of the clinical data. In the clinical trial community, data discrepancies are
typically handled using queries, whereas data point annotations are documented in notes. Whether or
not Notes and Discrepancies are used in a Study depends on your Study configuration. See the
ClinCapture Study Administration Guide for details.
There are various situations where you would use Discrepancy Notes. For example:
 When capturing or validating data in order to flag an item as incomplete or as having a value
that is not expected.
 To provide an explanation about, or annotate, a field value in a Discrepancy Note.
ClinCapture can automatically create a Discrepancy Note under the following circumstances:
 When you save a CRF that contains unexpected data, according to an edit check rule.
 When you manually run imported edit check rules.
After a Study Monitor, Site Monitor, or Administrator creates a Discrepancy Note, another user, for
example a Clinical Research Coordinator, reviews the Discrepancy Note and updates it to help resolve
the issue.
The original Note is referred to as the Parent Note. Responses to the original Note are referred to as
Child Notes. A single Parent Note with all the Child Notes under it are referred to as one Discrepancy
Note.
A Discrepancy Note is associated with a single data element, usually a CRF Item such as a diagnosis,
medication, or weight, but it can also be associated with data pertaining to the Subject record, such as
sex or date of birth, or the Study Event, such as the date or the location.
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After a Discrepancy Note is created, it cannot be deleted. If a Discrepancy Note is created erroneously, a
common practice is to add a new Child Note with a Status of Closed.
To use Notes and Discrepancies, your browser must have:
 JavaScript enabled
 Pop-up blockers disabled
A Discrepancy Note has four key properties, which the user assigns when creating the Note:




Note Type
Status
Description
Detailed Note
After a Discrepancy Note has been created, you cannot change the Note type. To update the other
properties, you add new Child Notes.
Note: If CRF masking functionality is being used, you cannot work with notes or discrepancies for CRFs
that have been masked from you.
4.9.1 Discrepancy Note Types
The purpose, behavior, and workflow are different for each Note type. The Note type you can assign to
an element depends on when the Note is created. ClinCapture has the following Note types:




Failed Validation Check
Query
Reason For Change
Annotation
Failed Validation Check
A Failed Validation Check Note type is for data that does not comply with the expected values, also
referred to as a Soft Validation Check. Refer to Manual Data Entry for details on the differences between
a Hard Validation Check and a Soft Validation Check. When initially created, the Status is New. The Note
then requires further review to determine if the data is acceptable. ClinCapture can automatically
generate this Note type when validating a field, according to its associated rules.
There are two ways to handle a Failed Validation Check:
 Before a CRF is saved. For example, an inclusion criterion is not met and the data entry person
knows that the newly entered data will not pass validation. In this case, they can annotate the
field in question before a query is generated, and ClinCapture realizes that the failed validation
is intentional. Thus, it will create a Failed Validation Check Parent Note and the data entry
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annotation as a Child Note. If this condition is met, the Failed Validation Check is considered
handled, and no error message is reported when the CRF is saved.
 After a CRF is saved. ClinCapture first displays a warning message. If the user does not change
the value to one that conforms to the expected value for the Item, it automatically creates a
Failed Validation Check Note.
ClinCapture also generates this Note type when imported data does not conform to the expected
values.
Query
A Query Note type is used to ask a question about data provided for a CRF item. For example, a Study or
Site Monitor can create a Query Note to inquire about a CRF item that seems incomplete or incorrect,
even though the item has met all automated edit checks.
Below is the typical workflow:
 A Study-level user creates a Query Note. The Query Note status is New. The note originator
assigns and directs the Query Note to the user who can address the issue, typically the person
who entered the data.
 The user assigned to the query updates it by adding a new Child note to the Parent. The user
may or may not modify the data value in conjunction with the update. The Query Note status is
set to Updated.
 The note originator reviews the response and, if satisfied, marks it as Closed, or updates it with
additional comments, and assigns it back to the user.
Reason For Change
A Study can be configured to force users to document any data changes made after a CRF has been
marked Complete. ClinCapture automatically converts an Annotation to a Reason For Change Note
when a change is made to a completed CRF, and the data entry person enters an Annotation for the
changed field. A Reason For Change Discrepancy Note always has a status of Not Applicable.
Annotation
An Annotation Discrepancy Note allows users to enter information to clarify data that cannot be
adequately represented or explained in the CRF. Refer to your study’s CRF completion guidelines about
the appropriate use of Annotations. Annotation Notes always have a Status of Not Applicable.
4.9.2 Discrepancy Note Status
The Status for a Discrepancy Note indicates who is responsible for the next step. The Discrepancy Note
type determines what status values are allowed.
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The following table shows the different Discrepancy Note Status values:
Icon
Status
Description
New
This is the initial status for a Query or Failed Validation Check Note type.
Updated
Used when responding to a Note.
Closed
This is the final status for a Failed Validation Check or a Query Note. When a
Note has a status of Closed, it cannot be changed in any manner. Child Notes
cannot be added. Only Study-level users can mark a Discrepancy Note as Closed.
Not Applicable This Status is reserved for Reason For Change and Annotation Note types
because no further action is required. The Status of Not Applicable cannot be
used for Failed Validation Check and Query Note types.
When more than one Discrepancy Note is associated with a CRF Item, the highest priority Status is
shown. The following priorities are used to classify Discrepancy Notes, starting with the highest priority:
1- New
2- Updated
3- Closed
4.9.3 Creating Discrepancy Notes
Discrepancy Notes can be created automatically by ClinCapture, or by users.
Automatically-Created Discrepancy Notes
ClinCapture can automatically generate Discrepancy Notes under Administrative Editing, data validation
checks, and data import as follows.
 When a CRF is marked Complete and you change a CRF item under Administrative Editing,
ClinCapture prompts you to enter a Reason For Change if the Study configuration is set to force
a Reason For Change. To avoid being prompted, you can enter a Discrepancy Note for the item
changed before saving the CRF.
 When a data item entered into a CRF does not pass its Soft Validation Checks and you click Save,
ClinCapture prompts you to provide a valid value. If you do not correct the data after being
prompted and click Save again, ClinCapture saves the CRF and automatically creates a
Discrepancy Note. For details, see Manual Data Entry.
 When you import data into ClinCapture, if errors are found ClinCapture automatically generates
a Failed Validation Check.
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Note: In some cases, ClinCapture does not allow you to import data; for example, when Hard
Validation Checks are triggered by invalid Date formats.
User-Created Discrepancy Notes
A user can generate a Note in ClinCapture during data entry or when reviewing a CRF, as follows.
1. Click the Add Discrepancy Note icon (
) next to the item.
2. The Add Discrepancy Note window opens.
Note: The content of this window may look different depending on your user role.
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3. Complete the Description and Detailed Note fields as required.
4. If your user role is Study Monitor, Site Monitor, Study Coder, or Study Administrator, select
Query or Annotation as the Note type from the drop-down list. Investigators and Clinical
Research Coordinators do not have the option to enter a note type; any note they enter is
considered an Annotation.
5. For a Query Note, select the user from the Assign to User drop-down list that can best handle
the issue resolution.
Note: ClinCapture does not prevent other users from updating the Note.
To send an email to the assigned user, select the E-mail Assigned User checkbox. When an
Investigator or Clinical Research Coordinator updates a Note, it is automatically assigned back to
the originator.
6. Click Submit & Close.
A message replaces the contents of the window, indicating a Note was created. The window
then closes automatically.
In the CRF page, the flag icon for the Item is changed to a color that reflects the status of the
Discrepancy Note.
 The flag icon color is white ( ) if the note entered was an Annotation.
 The flag icon color is red ( ) if the note entered was a Query.
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Multiple Discrepancy Notes for a CRF Item
If a Discrepancy Note already exists for a CRF item, and you want to create a new, different Note for the
item, you can do so by following these steps:
1. In the CRF, click the flag icon for the existing Discrepancy Note for that Item. ClinCapture opens
the Notes and Discrepancies window, which contains details for the item.
2. Click Begin New Thread.
3. Complete the process as if adding a new Discrepancy Note.
4.9.4 Viewing a Discrepancy Note
To see a list of Discrepancy Notes or to find a Discrepancy Note, see Viewing Discrepancy Notes. To view
a Discrepancy Note in ClinCapture:
1. Open the CRF page that contains the Discrepancy Note.
2. Position your pointer over the flag icon for the Item with the Discrepancy Note. ClinCapture
displays a pop-up window with summary information about the Discrepancy Note.
3. Click the flag icon to view the details about the Discrepancy Note. ClinCapture displays the
details of the Discrepancy Note in the Notes and Discrepancies window. If there are multiple
Discrepancy Notes associated with the CRF Item, each Note is presented in a separate table, and
has a unique Note ID.
4. When you are finished viewing the Note details, click Close Window.
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4.9.5 Updating a Discrepancy Note
You can update any Discrepancy Note within your current Study or Site scope, even if it is assigned to
someone else.
To update a Discrepancy Note:
1. Open the Discrepancy Note you want to update in one of the following ways:


Open the CRF with the Discrepancy Note, and click the flag icon for the item you want to
change.
From the Notes & Discrepancies page, sort and filter to select the Notes and Discrepancies
of interest. Click the View icon to display the Discrepancy Note. Click the View Within
Record icon to display both the Discrepancy Note and the associated CRF.
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2. Click the Update Note button. A new section is displayed allowing you to enter a Description
and Detailed Note for your update. These notes updates are reviewed later on by the Study
Monitor, Site Monitor, or Study Administrator.
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3. Click Submit to save the updated information but keep the window open, or click Submit and
Exit to save the updated information and close the window.
The Discrepancy Note now includes the information you provided as a new Child Note in the
thread.
If you do not want to save any of the information, click the Close Window (
) icon.
4. In the CRF and in the Notes and Discrepancies page, the color of the flag icon for that note
changes to yellow ( ) to reflect the Updated status.
Notes:
If the note is a Query or a Failed Validation Check, and your user role is Study Monitor, Site
Monitor, Study Coder, or Study Administrator, you can assign the note to any user in the Study
and you can select the E-mail Assigned User checkbox to send an email alert to the assigned
user.
If a user changes a CRF data under Administrative Editing as a result of a query, he can update
the query and does not need to enter a Reason For Change (RFC). ClinCapture will automatically
process the query Update as a Reason For Change.
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4.9.6 Managing Discrepancy Notes
The Notes and Discrepancies page provides a summary of Notes and Discrepancies related to your
current scope: Study or Site. The notes accessible to you also depends on your role. Study Coder and
Study Evaluator only see the Notes and Discrepancies associated with their tasks.
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Figure 26: Notes and Discrepancies page
A quick way to access only the Notes and Discrepancies assigned to you is from the ClinCapture Home
page. The Home page reports how many Notes and Discrepancies are assigned to you in the current
Study or Site. Click the Notes & Discrepancies Assigned to Me link to view details about your Notes in
the Notes and Discrepancies page.
To view the page with all Notes and Discrepancies for the current Study or Site, click Notes &
Discrepancies in the Navigation Bar.
The table at the top of the page contains summarized notes and discrepancy statistics. Click a value in
this summary table to filter the details table at the bottom of the page to show only those items. Figure
27 shows an example of the details table, filtered to show only two Annotations, after clicking the
number 2 in the summary table.
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Figure 27: Notes and Discrepancies page filter example
You can filter the Notes and Discrepancies details table by the following information:












Study Subject ID
Type: Failed Validation Check, Annotation, Query, Reason For Change
Resolution Status: New, Updated, Closed, Not Applicable
Site ID
Days Open
Days Since Updated
Event Name
CRF
Entity Name. This refers to the CRF Item for which the Note is associated.
Entity Value. The value recorded in the CRF for the Item.
Description. The title of the Discrepancy Note.
Assigned User. The person assigned to handle the Discrepancy Note.
Clicking Show More provides the following additional filters:
 Note ID
 Entity Type
In addition, Notes and Discrepancies can be sorted by the following:
 Note ID
 Subject ID
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 Date Created
 Days Open
 Days Since Updated
Notes and Discrepancies Actions
The following actions are available on the Notes and Discrepancies page.
Icon
Meaning
Description
Print
Print the selected item.
View
Displays information on the item.
View within
Record
Opens the Note and its associated location (CRF, event. Subject, etc.).
Download
Notes
Download notes.
4.9.7 Finding and Organizing Discrepancy Notes
ClinCapture has the following features to help you find and organize Notes and Discrepancies. These
features are similar to those used to find and organize data in the Subject Matrix.
Number of Discrepancy Notes per Page
The bottom left corner shows the total number of Discrepancy Notes relevant to you and the number
currently in view. When there are more Notes than can be listed on the page, use the green arrows to
scroll through the pages of Notes.
When there is only one page of Notes, the arrows are disabled (gray). To change the number of Notes
shown on a page, click the drop-down list next to the arrows and select a value: 15, 25, or 50 per page.
Sort Notes by Column
To sort the Notes by a column, click the column header. Some columns do not allow sorting by, in which
case, the pointer does not change shape when you position it over the column header. To reverse the
sort order, click the column header again. An arrow next to the column header indicates the current sort
order: up for ascending and down for descending.
For example, click the Study Subject ID column header to sort by that column, with the lowest Study
Subject ID value first. Click the column header again to show the highest Study Subject ID value first. The
arrow in the column header then points down.
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Filter Notes to Show Only Matches for Specified Criteria
You can filter the information shown in the Notes and Discrepancies page to show only Notes and
Discrepancies whose data match the criteria that you specify.
 For the column whose data you want to filter, click the gray field below the column header.
 What you enter in a field depends on the type of field:


If a drop-down list displays, select the value you want to use as the filter.
If no list displays, type in the string of characters you want to filter by, and press Enter or
click Apply Filter (located to the far right of the gray fields).
You can add more filters, if necessary.
To remove filtering for a column, clear the text you entered, or from a drop-down list, select the blank
(top) item.
When filtering is applied, only those Notes and Discrepancies containing the data you specified are
shown. To clear all filtering and show all data, click Clear Filter (located to the far right of the gray fields).
Figure 28: Notes and Discrepancies filtered by Type
Discrepancy Notes per Subject
The View Subject Record page includes a Notes & Discrepancies action button. Clicking it opens the
Notes and Discrepancies page with all the notes and discrepancies for that Subject. If needed, you can
further filter these Notes to find the exact information you are looking for.
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Notes & Discrepancies Assigned to Me
At the top of the Home page, there is a Notes & Discrepancies Assigned to Me link. Clicking on it displays
the Notes and Discrepancies page showing your assigned Notes that are either New or Updated. This is a
quick way to find the Notes that you need to process.
4.9.8 Downloading Discrepancy Notes
To download Discrepancy Notes to a file:
1. Filter the Notes and Discrepancies to show only the Notes that you want to download. All data
for those Notes will be downloaded—that is, all the data that appears in the Show More view.
2. Select the file format to download the data into using the PDF or CSV icons (
).
Comma separated values (CSV) is best to use with other software, such as a spreadsheet or
database. The CSV file contains one row for each Note, whether it is a Child or Parent Note.
Portable document format (PDF) creates a file that is easy to read and print. The PDF file shows
a Parent Note in bold, followed by the Child Notes associated with the Parent Note in the
normal font style.
3. Depending on your browser settings, you might be prompted to open or save the downloaded
file.
4. Click Close Window.
4.9.9 Generating Discrepancy Correction Forms (DCFs)
A Discrepancy Correction Form (DCF) is a PDF version of a discrepancy that can be sent to the site
electronically by FAX or email, or printed and delivered to the site.
You can generate DCFs for New or Updated discrepancies only.
The DCF generation feature is only available if Study parameter, Allow Discrepancy Correction Forms, is
yes.
The following roles may have access to the DCF feature:




System Administrator
Study Administrator
Study Monitor
Study Coder
To generate DCFs for New discrepancies:
1. To make selection easier, filter the Notes and Discrepancies to show only New discrepancies.
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2. Select one or more discrepancies for which to generate DCFs by checking the corresponding
box(es) in the DCF column.
Alternatively, click the Generate DCF icon in the Actions column.
3. Click Generate DCF.
4. Select one or more of the following:



Save the DCF – Download the DCF in PDF format. You can then electronically FAX or email
the document.
Print the DCF – Open the DCF in PDF format. You can then use your browser’s print feature
to print the DCF and FAX or deliver it to the site.
Email the DCF to – Email the DCF. If you select this option, specify the email address to
which it should be sent.
5. Click Generate DCF.
The discrepancy status is changed to Updated, and a child note is added to indicate a DCF has
been generated. The note also indicates how the DCF was generated (Saved, Printed, Emailed).
If you selected Save the DCF, the DCF is downloaded in PDF format. If multiple discrepancies
were selected, a single PDF is generated. Line breaks separate each generated DCF.
If you selected Print the DCF, the DCF opens in PDF format. Use your browser’s print feature to
print the DCF.
If you selected Email the DCF, the DCF is emailed to the address specified.
To generate DCFs for Updated discrepancies:
1. To make selection easier, filter the Notes and Discrepancies to show only Updated
discrepancies.
2. Click the Generate DCF icon in the Actions column.
3. Click Generate DCF.
4. Select one or more of the following:
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


Save the DCF – Download the DCF in PDF format. You can then electronically FAX or email
the document.
Print the DCF – Open the DCF in PDF format. You can then use your browser’s print feature
to print the DCF and FAX or deliver it to the site.
Email the DCF to – Email the DCF. If you select this option, specify the email address to
which it should be sent.
5. Click Generate DCF.
The discrepancy status is changed to Updated, and a child note is added to indicate a DCF has
been generated. The note also indicates how the DCF was generated (Saved, Printed, Emailed).
If you selected Save the DCF, the DCF is downloaded in PDF format. If multiple discrepancies
were selected, a single PDF is generated. Line breaks separate each generated DCF.
If you selected Print the DCF, the DCF opens in PDF format. Use your browser’s print feature to
print the DCF.
If you selected Email the DCF, the DCF is emailed to the address specified.
4.10 Special Permissions
Study Monitor, Site Monitor, and Study Coder user roles cannot access the Submit Data module. For
information about features in the module, see Submitting Data.
Table 3: Submit Data Permissions by feature
Feature
Task
User Role / User Type
Subject Management
Remove a Subject from a Study
or Site or to restore a Study
Subject.
 Study Administrator
 Investigator
Assign a Subject to another Site
within the Study.
 Study Administrator
Lock/Unlock a Subject.
 Study Administrator
Events and Casebooks
Sign a Study Event or a Subject
Casebook.
 Investigator
CRF Data and Events
Remove and restore Study Event  Study Administrator /
CRFs and Study Events.
Administrator
Set Study Event Status to locked.  Study Administrator
Notes and Discrepancies
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 Study Monitor
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 Site Monitor
 Study Coder
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5 MONITOR AND MANAGE DATA
The ClinCapture Monitor and Manage Data module allows you to oversee and validate data for a Study,
promoting increased productivity in clinical trials management. Access to the features in the module
depends on your user role, see ClinCapture Modules.
The Monitor and Manage Data module consists of the following features:
 Source Data Verification (SDV): Track your evaluations of data conformity reviews for CRFs and
Study Subjects. This helps to ensure that the Study is complete, accurate, and verifiable.
 Study Audit Log: View the change history for each Study Subject in log format and use it to
facilitate the Study validation process.
 Code: Transform verbatim term descriptions of medical diagnoses, procedures, and drugs into
universal medical code numbers. This facilitates a precise tracking of diseases, thereby ensuring
that these terms are used uniformly.
 Rules: Use Rules Studio to define edit checks, enabling you to verify the validity of data entered
in a CRF for a Study. Rules Studio also allows you to manage existing rules for a Study, create
new rules for a Study, or copy rules from one Study to another.
 Subject Matrix: View information about each Subject in the Study or Site from the Subject
Matrix.
 View Events: View information about any Study Event.
 Notes & Discrepancies: Use Notes and Discrepancies for query and discrepancy management to
help you verify the accuracy and completeness of data in a clinical trial.
5.1 Source Data Verification
Source Data Verification (SDV) helps you review your CRF data for conformity and track evaluations, to
ensure your Study is complete, accurate, and verifiable.
When using SDV, ClinCapture presents CRFs ready for you to verify. You can perform source data
verification either by Event CRF or by Subject. You can also use filters to show only the CRFs you are
interested in. After you have verified the data, you can mark the CRFs as either verified individually or as
a group. SDV can be done at the CRF level or at the item level, depending on the study requirement.
When CRFs are added as part of configuring the Study Event, the Study Administrator must specify
whether or not SDV is required. If SDV is required, the CRF must be configured for form-level or itemlevel SDV. If item-level SDV is required, the specific items to be source data verified must be specified in
the View CRF Version Details page (Tasks -> CRFs -> View -> Metadata).
Note: If CRF masking functionality is being used, users will not be able to SDV CRFs that are masked
from them. Masked CRFs will not display on the SDV page.
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5.1.1 Verifying Source Data
Study Monitor and Site Monitor users can verify source data in ClinCapture.
To perform CRF-level Source Data Verification:
1. Change the current Study or Site to the one where you want to perform Source Data
Verification.
2. Click a completed event to open the Event pop-up
3. Click the SDV action icon for the Subject or Event you want to verify. The Source Data
Verification page for the current Study or Site opens with the necessary information to filter the
Subject or the Event.
4. Select Tasks > Source Data Verification.
The Source Data Verification page for the current Study or Site opens with unfiltered
information.
By default, the View By Event CRF tab displays, which lists only completed CRFs that are ready
for Source Data Verification. Click the CRF status icon in the CRF Status column for the CRF you
want to view.
The View By Study Subject ID tab lists all Subjects in the current Study or Site. Click the View
icon in the Actions column for the Subject you want to view to show all Event CRFs ready for
verification for that Subject. Click the CRF status icon for the CRF you want to view.
You can customize the view to show only those CRFs or Subjects whose data you want to verify,
see Customizing the View.
5. The completed CRF opens in a new window where you can review the data in the CRF.
6. If necessary, add a Query type Discrepancy Note to record a question about any Item.
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7. When you have finished reviewing the data in the CRF, click the Close button in the CRF window.
Note: If you click Exit instead, the window remains open, showing the Subject details.
8. Click the SDV icon to mark the CRF data as verified. In the SDV status column, the checkbox is
replaced by an SDV Complete icon ( ). The Event CRF Source Data Verification Status is logged
in the Subject Audit Logs, along with the date, time, and name of the user that performed the
data verification.
9. Continue viewing details and marking CRFs as verified, and changing the view as needed. You
can mark multiple CRFs as verified in any of the following ways:



All Eligible CRFs for a Subject: In the Study Subject ID view, click the SDV button for the
Subject to mark all eligible CRFs for that Subject as verified.
Selected CRFs or Subjects: In either the CRF or Subject view, select the checkbox in the SDV
Status column for all CRFs or Subjects that you want to mark as verified. You can deselect a
row by clicking the checkbox again, or clear all selected rows by clicking the None link
(located above the column headers). Click the SDV All Checked button at the bottom of the
page.
All CRFs or Subjects Shown: In either the CRF or Subject view, click the All Shown link
(located above the column headers) to select all CRFs or Subjects on the page. You can
deselect a row by clicking its checkbox, or clear all selected rows by clicking the None link
(located above the column headers). Click the SDV All Checked button at the bottom of the
page.
To perform item-level Source Data Verification:
1. Change the current Study or Site to the one where you want to perform Source Data
Verification.
2. Click a completed event to open the Event pop-up
3. Click the SDV action icon for the Subject or Event you want to verify. The Source Data
Verification page for the current Study or Site opens with the necessary information to filter the
Subject or the Event.
4. Select Tasks > Source Data Verification.
The Source Data Verification page for the current Study or Site opens with unfiltered
information.
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By default, the View By Event CRF tab displays, which lists only completed CRFs that are ready
for Source Data Verification. Click the CRF status icon in the CRF Status column for the CRF you
want to view.
The View By Study Subject ID tab lists all Subjects in the current Study or Site. Click the View
icon in the Actions column for the Subject you want to view to show all Event CRFs ready for
verification for that Subject. Click the CRF status icon for the CRF you want to view.
You can customize the view to show only those CRFs or Subjects whose data you want to verify,
see Customizing the View.
5. The completed CRF opens in a new window where you can review the data in the CRF.
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6. To quickly find the items that need SDV, use the CRF shortcut. Click the number link in the Items
to SDV column. The first item on the CRF that requires SDV will be presented and highlighted in
yellow.
7. If necessary, add a Query type Discrepancy Note to record a question about any Item.
8. When you have finished reviewing the item data, click the blue SDV required button to the right
of the item to mark the item as verified.
9. The SDV icon changes to a green Source Data Verified icon.
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10. Click the number link in the Items to SDV column again to jump to the next item requiring SDV.
11. Continue viewing the CRF and marking items as verified.
12. The Event CRF Source Data Verification Status is logged in the Subject Audit Logs, along with the
date, time, and name of the user that performed the data verification, when all items to be
source data verified have been marked SDV-ed.
13. You can mark all items on one or multiple CRFs as verified in any of the following ways:



All Eligible CRFs for a Subject: In the Study Subject ID view, click the SDV button for the
Subject to mark all eligible CRFs for that Subject as verified.
Selected CRFs or Subjects: In either the CRF or Subject view, select the checkbox in the SDV
Status column for all CRFs or Subjects that you want to mark as verified. You can deselect a
row by clicking the checkbox again, or clear all selected rows by clicking the None link
(located above the column headers). Click the SDV All Checked button at the bottom of the
page.
All CRFs or Subjects Shown: In either the CRF or Subject view, click the All Shown link
(located above the column headers) to select all CRFs or Subjects on the page. You can
deselect a row by clicking its checkbox, or clear all selected rows by clicking the None link
(located above the column headers). Click the SDV All Checked button at the bottom of the
page.
Note: Once a CRF is source data verified, if a change is required to an item that is not to be SDV-ed,
the CRF will keep its SDV status.
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5.1.2 Customizing the View
You can customize the view of the Source Data Verification page to adapt it to your workflow. For
example, you can review all CRFs for a particular Subject. Or if you use a sampling method, you can
review a sample of CRFs for a Site, and then mark all CRFs for that Site as verified.
This section describes the various ways you can customize the SDV view.
SDV by CRF
Open the View By Event CRF tab. All CRFs in the current Study or Site that are eligible for Source Data
Verification are shown. To be eligible, CRFs must be marked as Completed and discrepancies may or
may not be opened depending on your study configuration.
CRFs are listed by Event Date, with the oldest at the top of the page. The CRF view also reports the level
of Source Data Verification required for a CRF (shown in the SDV Requirement column, and specified in
the CRF Event Definition). After verifying the data, you can mark one CRF or selected CRFs as verified.
SDV by Event
Open the Subject Matrix and click on a completed Event to open the Event pop-up. Click the SDV action
icon for the Event. The Source Data Verification page opens and displays all eligible CRFs associated with
this Event.
SDV by Subject
There are two options for performing SDV by Subject:
 Option 1: Open the Subject Matrix, click on a Completed Event to display the pop-up, and click
the SDV action icon for the Subject. The Source Data Verification page opens and displays the
CRFs associated with this Subject.
 Option 2: Open the View By Study Subject ID tab. All Subjects in the current scope (Study or
Site) are shown, along with how many CRFs are eligible for verification and how many have
already been verified, as shown in CRFs Completed and CRFs SDV columns. The view lists all
Subjects, even those with no CRFs eligible for Source Data Verification, marked as SDV N/A in
the Actions column.
You can mark all CRFs for one or more Subjects as verified using this view.
You can also click the View icon to open the SDV by CRF view to access the list of all CRFs eligible for SDV
for that Subject.
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5.1.3 Finding and Organizing SDV Data
Either in the CRF or Subject view, you can:
 Navigate through the pages and change the number of CRFs or Subjects shown per page
 Show more data for all rows, or hide them
 Filter the data so it shows only the CRFs or Subjects that you want to see
These features work the same as in the Subject Matrix. See Finding and Organizing Data for more
information.
5.1.4 Viewing SDV Status
In the CRF view, icons in the SDV Status column indicate the CRFs that have had Source Data Verification
completed and those that have not. Use the filter for the SDV Status column to show only those CRFs
with SDV complete, or only those CRFs with incomplete SDV.
In the Subject view, icons in the SDV Status column indicate those Subjects that have had Source Data
Verification completed and those that have not. In addition, you can see how many CRFs have had SDV
completed for each Subject as shown in the CRF column.
5.1.5 Resetting SDV Status
Source Data Verification status can be reset from verified to unverified either manually by a user with
appropriate permissions, or automatically by the ClinCapture software. Unverified CRFs can be verified
again later on. The Study Audit Log tracks any change in Source Data Verification status for a CRF.
 Automatically: ClinCapture automatically resets the Source Data Verification status for a CRF
from verified to unverified if the CRF data changes.
 Manually: To manually change the Source Data Verification status for any CRF in the Source
Data Verification page, click the SDV Complete icon in the SDV Status column.


SDV By Event View: Click the SDV icon for a CRF. After you click the icon, it becomes a
checkbox, and the CRF is no longer reported as verified.
SDV By Subject View: Click the SDV icon for a Subject to reset the SDV Status for all CRFs for
that Subject. After you click the icon, it becomes a checkbox, and all CRFs for that Subject
are no longer reported as verified.
5.2 Study Audit Log
Use the Study Audit Log to view the history of actions and data entered for Subjects in the current
Study. Only specific user roles can access the Study Audit Log, see ClinCapture Modules.
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You can access the Study Audit Log in either of the following ways:
 Click the Study Audit Log link in the Navigation Bar.
 Select Tasks > Study Audit Log.
The View Study Log page lists all Subjects in the Study. You can change the number of Subjects shown
per page, change the sort order, and filter the table to show only the Subjects that you want to see.
These features work the same as in the Subject Matrix. See Finding and Organizing Data for more
information.
Figure 29: View Study Log page
5.2.1 Viewing Audit Logs for a Subject
You can view the Study Audit Logs for a particular Subject in either of the following ways:
 Click the View icon in the Actions column of the View Study Log page.
 Click the View icon in the Actions column of the Subject Matrix. The View Subject page opens.
Click the Audit Log button for the Subject.
The Audit Logs page opens, providing a detailed history of all Events for the selected Subject.
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Figure 30: Audit Logs page for a Subject
5.2.2 Changes Tracked in the Study Audit Logs
Table 4 lists the changes tracked in the Study Audit Logs.
Table 4: Changes tracked in Study Audit Logs
Object
Tracked Changes
Study Subject
State Changes:
 Available
 Removed
 Signed
Subject ID change
Creation Date
Value change
Site assignment change
Group assignment change
Group change
Event
State Changes: Scheduled
 Data entry started
 Completed
 Stopped
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



Skipped
Locked
Removed
Signed
Start/End Date change
Location change
Creation Date
CRF
State Changes:






Initial data entry complete
Initial data entry completed with password
Double data entry complete
Double data entry completed with password
Marked complete
Completed with password
Properties change
Source data verification status changed
CRF Item
Data value updated
Data status change
Data deleted
Data inserted for repeating row
Medical Coding
The Study Audit Logs track the initial values for CRF Items provided during data entry, which are
reported as updated CRF Item data values. This only occurs when a value is provided; empty or nonexistent values are not tracked.
The Study Audit Logs do not track Discrepancy Notes, but you can view or download the full thread for
any Discrepancy Notes. Discrepancy Notes cannot be removed and are always available.
5.2.3 Exporting Study Audit Logs for a Subject
You can export the Study Audit Logs for a Subject to an Excel file. The first worksheet contains the
Subject information and the Study Event summary information. The remaining worksheets contain the
audit trail for each Study Event and its associated CRFs (one Study Event occurrence per worksheet,
where each occurrence is labeled from _1 to _n).
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Figure 31: Example Subject Study Audit Logs export
5.3 Medical Coding
You can use the Medical Coding feature to ensure the accuracy and consistency of documenting
diseases, adverse events (AEs), or drugs during the course of a Study. This feature allows you to
transform verbatim medical terms into universal medical code names and numbers.
ClinCapture supports five medical dictionaries: MedDRA, WHODrug, ICD-9-CM, ICD-10, and CTCAE.
ClinCapture also allows using multiple versions of the same dictionary in a CRF.
ClinCapture retrieves medical codes from the Bioportal repository.
The Medical Coding feature is available to Study Coder, System Administrator, and Study Administrator
user roles.
The Medical Coding page lists all medical terms in the Study. You can access the Medical Coding page by
clicking the Code link in the Navigation Bar, or selecting Tasks > Code.
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Figure 32: Medical Coding page
You can sort by Verbatim Term, Dictionary, Study Subject ID, Study Event, and CRF. You can filter
information to display items that match specific criteria. You can also use the Summary Statistics
dashboard to determine which medical terms have been coded and which have not, and filter the
results by clicking the respective links.
You can customize the Medical Coding page similar to the Subject Matrix, see Finding and Organizing
Data for more information.
When a Study is being built, the System Administrator or Study Administrator must indicate whether or
not medical coding is allowed.
If configured for your Study, the Auto-Code function automatically codes all verbatim items using the
coding information previously saved in a custom dictionary for similar verbatim items. Custom
dictionaries can be shared between studies. Before coding a verbatim term, you can modify the search
term in the Medical Codes column to allow the medical coder to correct misspelled or abbreviated
terms.
A Study Coder can open the CRF where the verbatim term is located by clicking the Open CRF icon (
or
) in the Actions column. This allows the Study Coder to understand the context for the verbatim
item and a raise query, if needed, by submitting a Discrepancy Note ( ).
Note: If CRF masking functionality is being used, items from CRFs that are masked from you will not be
shown on the Medical Coding table.
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5.3.1 Configuring Medical Coding for a Study
Only a System Administrator or Study Administrator can configure medical coding for a Study.
Note: If your study is hosted by ClinCapture, we must first validate your license with your ontology
provider. We will then register your account in the Bioportal virtual appliance to generate an
API key to be configured for your instance. Once these steps are completed, you will be able to
perform medical coding in your studies.
To configure medical coding for a Study:
1. Select Tasks > Build Study from the Navigation Bar.
2. Choose Design from the Set Study Status drop-down list, and click Save Status.
3. Click the Edit icon for the Create Study task to open the Update Study Details page.
4. Open the Study Parameter Configuration section, and scroll down to the Medical Coding section.
5. Set Allow medical coding to Yes.
6. Use the Code with Context setting to specify the amount of information displayed on the
Medical Coding page. If enabled, the Hide and Show More links appear above the data table on
the Medical Coding page.
7. Provide a name for the auto-code dictionary to enable the auto-code feature. Any name can be
used. To share the auto-code dictionary between studies, enter the same name in the other
studies.
8. Click Submit.
After you enable medical coding for a Study you can assign/add users to the Study Coder role to
facilitate coding of verbatim terms.
5.3.2 Coding a Medical Term
Medical coding can be performed for CRFs in the following states:




Data Entry Started ( )
Initial Data Entry Completed ( )
Completed ( )
Signed ( )—Coding a Signed CRF, causes it to lose its Signed status.
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Medical Coding cannot be performed for:
 Locked CRF (
)
Note: To correct a spelling issue with a Verbatim Term before coding a medical term, modify the name
in the Search box in the Medical Codes column.
To code a medical term:
1. Click on the Not Coded icon ( ) for the item you want to code. In this example, we are going
to medical code the first item, Arthritis.
2. Browse through the list of results until you identify the correct code for Arthritis.
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If you need more information on a specific code, click the HTTP link to directly access and
browse the Bioportal page for that code.
3. Click on Get Full Info to see detailed information for a specific medical code.
4. Click Code or Code & Alias. Selecting Code & Alias codes the item and adds an alias (synonym)
in the custom dictionary, enabling the automatic coding of similar verbatim items.
5.3.3 Medical Coding Status
The Status column on the Medical Coding page displays the coding status of medical terms.
The following table shows the different Medical Coding Status values:
Status
Description
Not Coded
The item has not been coded.
Coded
The item has been coded.
Code Not Found The search on a Verbatim Term yielded no coding results. This is either caused
by a code not found in the Bioportal repository or a communication error. It is
recommended to retry coding these items. In case of repeated coding failures,
try accessing the repository directly to find the code.
5.3.4 Resetting Medical Coding Status
Medical term status can be reset from Coded to Not Coded either manually by a user with appropriate
permissions, or automatically by the ClinCapture software. After resetting a medical term, it can be
coded again. The Study Audit Log tracks any change in Medical Coding status for a medical term.
 Automatically: ClinCapture automatically resets the Medical Coding status for a medical term if
the verbatim item in the CRF changes.
 Manually: To manually change the Medical Coding status for a medical term on the Medical
Coding page, click the Delete icon ( ). This allows you to delete the Code and/or Alias, and
reset the medical term to a Not Coded status.
5.4 Evaluate CRF Data
CRF Evaluation requires that data intended for a particular CRF must be reviewed by a Study Evaluator
to ensure the integrity of the captured data. It is typically used for measurement-related data points.
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Unlike Double Data Entry, CRF Evaluation is not blind. The Study Evaluator can see the initial CRF entry,
review it or perform the measurement again, and then accept the data, or change it if necessary. If the
evaluator changes the data initially entered, a Reason For Change (RFC) will be automatically generated.
Note: If CRF masking functionality is being used, you cannot evaluate CRFs that have been masked
from you.
5.4.1 Study Configuration
Before you can use CRF Evaluation in your study, you must set up the required properties and user roles.
The CRF Evaluation Set Up workflow is as follows:
1. Enable CRF evaluation for the study
2. Assign the role of Study Evaluator to one or more study-level users
3. Create Events and configure CRF(s) within those events
CRF Evaluation has two system-level properties:
 Allow CRF Evaluation – Allows the Evaluator to appear when defining users or changing roles of
study-level users.
 Evaluate with Context – Displays additional information on the reading page, such as Subject ID
and the Event Name. (The system-level properties can be overridden at the study level.)
CRF evaluation allows users with the role of Evaluator to only access the CRF(s) to be evaluated, without
being able to access any other data in the study. Just like a CRC, this role is allowed to edit/view/print
the CRFs to be evaluated.
When a CRF is determined to need evaluation, a setting must be turned on in the Edit Study Event
Definition page. If the option, CRF data evaluation, is selected, the CRF appears in the CRF Evaluation
page once its status is Initial Data Entry Completed; that is when the initial data is completed and
submitted for evaluation.
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Data evaluation is carried out by a Study Evaluator. This role is defined at the Study level. As a Studylevel role, the Evaluator has access to all sites under a study. The Evaluator does not see any other study
data, including queries, except those they generate themselves.
5.4.2 CRF Evaluation Widget
You can customize your Home Screen to display the CRF Evaluation Widget. For users with the role of
Evaluator, this widget allows you to quickly see, in a graphical format, how many CRFs are ready to be
evaluated and how many have already been evaluated over a period of time.
You can click a colored status section of a bar in the graph to go directly to the CRF Evaluation page.
Depending on the status you clicked, the CRF Evaluation page will be filtered to show only those CRFs
that are Ready for Evaluation or those that have been marked Evaluation Completed.
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5.4.3 Performing CRF Evaluation
To evaluate CRF:
1. Select Tasks > Evaluate CRF to open the CRF Evaluation page.
2. You can click the counters in the Summary Statistics box to filter the list to show only those CRFs
with a particular evaluation status, or to show all CRFs that have been marked complete.
3. CRFs with a yellow checkmark are ready for evaluation.
4. Click the Begin CRF Evaluation button. The CRF opens.
5. Evaluate the data points/measurements. If necessary, make changes.
6. Check the Mark CRF Complete box.
7. Click Save.
After the CRF has been saved:
 The status of the CRF changes to Evaluation Completed.
 The CRF is now ready for SDV monitoring (if required) or e-signature.
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 If any change was made to a data point on the CRF, a discrepancy automatically is logged.
5.5 Rules
Edit checks, or rules, are needed to ensure the validity of the data when a Study is created.
The Manage Rules page lists all rules in the Study for CRFs in the Available state. You can access the
Manage Rules page by selecting Tasks > Code.
Figure 33: Manage Rules page
You can filter the list of Rules by CRF, Item Name, Rule Name, Expression, Execute On, and Action
Summary.
You can perform the following actions from the Manage Rules page:





Design a new rule for a CRF using Rules Studio
Edit existing rules using Rules Studio
Import rules from an XML file, which you can edit in Rules Studio
Download a rule to an XML file
Test rules
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5.5.1 Rules Studio
The Rules Studio feature in ClinCapture simplifies the creation and modification of rules, allowing
System Administrators and Study Administrators to implement, modify, and copy rules using an intuitive
drag and drop graphical user interface.
The Rules Studio interface contains the following sections:






Top Panel
Data, Macros, and CRF Items Panels
Operators Panel
Expression Builder
Parameters Panel
Bottom Panel
Figure 34: Rules Studio
Top Panel
The Top Panel is the area at the top of the Rules Studio and contains the logo and a link to watch a short
tutorial that shows you how to use Rules Studio.
Data, Macros, and CRF Items Panels
The Data Panel contains the different data field types that you can drag and drop into the Expression
Builder: Text, Number, and Date.
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The Macros Panel contains the Current date and Empty macros that you can drag and drop into the
Expression Builder.
The CRF Items Panel is the area on the right side of the Rules Studio, just below the Data and Macros
panels. From this area you can drag and drop CRF Items from a selected Study into the Expression
Builder. As you navigate through the information path of a study (Study, Event, CRF, CRF version, and
CRF Item), your current path appears at the bottom of the panel, as a bread crumb. Click on any part of
this bread crumb to navigate back to that level in the path.
Operators Panel
The Operators Panel consists of four tool boxes: Group, Compare, Calculate, and Condition. Each tool
box contains operations that you can drag into the Expression Builder. For information on entering data,
see Designing Rules.
Expression Builder
The Expression Builder is the area just below the Operators Panel. This is where you design or modify
your rules. A rule is composed of data items, selected from the Data/Macro/CRF Items panels and
various operators chosen from the Operators Panel. As you drop items into the Expression Builder, Rules
Studio tries to predict your next action and displays a box with dotted lines matching the next expected
item.
Parameters Panel
The Parameters Panel is the area just below the Expression Builder. This area allows you to specify the
parameters for your rules, in particular, the rule description, the rule target (the CRF item to attach the
rule to), and the type of action implemented in response to a rule evaluating to either true or false.
After designing a rule, you can verify the rule by clicking the Validate Rule button in the Bottom Panel.
Bottom Panel
The Top Panel is the area at the bottom of the Rules Studio and contains the Validate Rule and Exit. Use
the Validate Rule button to verify your rules.
5.5.2 Designing Rules
To confirm the accuracy of data captured in a CRF of a Study you must design and implement rules,
sometimes referred to as Soft Edit Checks. In ClinCapture, you use the Rules Studio to design rules.
To design a rule for a CRF:
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8. Select Tasks > Rules to open the Mange Rules page.
9. Click Design a Rule. The Rules Studio interface opens.
10. Use the Expression Builder to create your rule.
11. Click Validate Rule to verify your rule.
12. If the rule successfully validates, click Save to save the rule. Otherwise, click Back and modify
your rule as needed.
For an example on how to design a rule using Rule Studio, click the Watch Tutorial button in the Top
Panel.
5.5.3 Editing Rules
To edit an existing rule:
1. In the Manage Rules page, click the Edit icon (
to modify. The Rules Studio interface opens.
) in the Actions column for the rule you want
2. Use the Expression Builder to modify the rule.
3. Click Validate Rule.
4. If the rule successfully validates, click Save to save the rule. Otherwise, click Back and modify the
rule as needed.
5.5.4 Importing Rules
You can import rules created in XML and edit them using the Rules Studio.
To import an XML rule:
1. In the Manage Rules page, click the Import Rules button. The Import Rule page opens.
2. Click Browse.
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3. Select the XML file containing the rules you want to import, and click Open.
4. Click Continue.
Imported rules can be edited in Rules Studio by clicking on the Edit icon (
) in the Actions column.
5.5.5 Exporting a Rule
You can export an existing rule to an XML file. To do so, in the Manage Rules page, click the Download
icon ( ) in the Actions column for the rule you want to export.
5.5.6 Testing Rules
You should manually test your rules to ensure they function properly.
To test a Rule:
1. In the Manage Rules page, click the Test icon (
) for the rule you want to test.
Note: Alternatively, you can click the Test Rules button at the bottom of the page to type in
rules and test them. In this case, be prepared to enter the target OID, expression OIDs,
and action from a blank form.
2. The Test Rules page opens where, if desired, you can edit the existing target, the rule
expression, and the actions to take if the expression evaluates to either true or false.
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You can display all rules applicable to the Item Name by clicking View all rules for this item. The
Manage Rules page shows all rules for the specific item.
3. Click the Submit button.
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4. Enter the necessary test variables, and click Submit.
The Verify results section summarizes the results of the test, and identifies whether or not the rule is
valid. If the rule is invalid, a diagnostic message appears in the Alerts & Messages panel, otherwise, the
rule executes with the test parameters you supplied and the results are shown. Whether or not the
specified action was triggered is indicated along with the execution time.
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5.6 Reports
Using Live Reports™, Study Administrators, Study Monitors, and Site Monitors can access graphical
dashboards to monitor their Studies in real time. No data extraction is required; the information is
available in your reports as soon as it is available in the ClinCapture database. These reports are
available through the Pentaho User Console. Please consult the ClinCapture Programmer’s Guide for
details about creating your own custom reports, or visit the ClinCapture Community for the availability
of new reports.
To access the Reports feature:
1. Select Tasks > Reports. If your system is configured for this feature, it will open a new window.
2. Enter your ClinCapture username and password, and click Login.
3. If the navigation panel on the left is not visible, click the Toggle Browser icon in the menu bar.
4. Click the Clincapture folder in the navigation panel to display the reports currently available.
The following report types are available:
 Enrollment by Site—displays the enrollment dashboard by Sites.
 Enrollment by Month—shows the cumulative enrollment in metrics for all Sites, per month.
 Query Status Report—shows the total queries by status per Site, excluding annotations.
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5.7 Special Permissions
System Administrator, Study Administrator, Study Monitor, Site Monitor, and Study Coder user roles can
access the monitoring features in the Monitor and Manage Data module. For information about features
in the module, see ClinCapture Modules.
Table 5: Monitor and Manage Data Permissions by role
User Role
Task
Notes
System Administrator
Source Data Verification
No restrictions
Study Audit Log
No restrictions
Medical Coding
No restrictions
Rules
No restrictions
Group
No restrictions
CRFs
No restrictions
Reports
No restrictions
Source Data Verification
No restrictions
Study Audit Log
No restrictions
Medical Coding
Study level only
Rules
Study level only
Group
Study level only
CRFs
Study level only
Reports
No restrictions
Subject Matrix
Can only view. Cannot make
changes to information.
View Events
Can only view. Cannot make
changes to information.
Source Data Verification
No restrictions
Study Audit Log
No restrictions
Notes and Discrepancies
Can create only the Query type of
Discrepancy Note.
Can only update or close an
existing Discrepancy Note.
Reports
No restrictions
Study Administrator
Study Monitor
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Site Monitor
Study Coder
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Can only view. Cannot make
changes to information.
View Events
Can only view. Cannot make
changes to information.
Source Data Verification
No restrictions
Study Audit Log
No restrictions
Notes and Discrepancies
Can create only the Query type of
Discrepancy Note.
Can only update or close an
existing Discrepancy Note.
Reports
No restrictions
Medical Coding
No restrictions
CRFs
Can only view. Cannot make
changes to information.
Notes and Discrepancies
Can only create Discrepancy
Notes related to medical coding.
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6 EXTRACT DATA
The ClinCapture Extract Data module allows you to define criteria for a set of data, and export it to a file
for use in other applications.
You can select a standard file format to export the data to, and then download the file. You can also
modify the criteria you previously defined, and create a new dataset using the revised definition. The
Extract Data module also provides you with tools to help you find and organize the dataset definitions in
a Study.
Only users with appropriate permissions, as defined by their user roles, can use the Extract Data
module. A Study Administrator can schedule export jobs to automatically extract data from time to time.
6.1 Dataset Creation
To create a dataset, you define the dataset criteria for the current Site or Study. After defining the
dataset criteria, you generate and download the dataset file, extracting the data that meets your
defined criteria to a file format that you select.
6.1.1 Defining a Dataset
Perform the following steps to define a dataset for the current Study or Site:
1. Select Tasks > Dataset. The Dataset page for the current Study or Site opens.
2. Click the Create Dataset button. The Create Dataset page opens.
3. Click Continue. The Create Dataset: View Selected Items page opens.
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4. Click on a Study Event to list the associated Event CRFs in the Left Panel. For example, click on
the Enrollment study event to list the following CRFs: Demographics, Randomization and Patient
Eligibility.
Note: If CRF masking functionality is being used, you cannot add items to a dataset from CRFs
that have been masked from you. CRFs that have been masked from you will not be
displayed in the Left Panel.
5. After clicking an Event CRF, the associated CRF Items that you can include in the dataset
definition are listed. Also displayed in the view is the metadata for each Item, as defined when
the CRF was initially created.
6. Click the checkbox for each Item to be included in the dataset definition, or click the Select All
Items checkbox.
Note: If you are selecting many, but not all, items in the CRF, it might be easier to check Select
All Items; then for each item that you want to exclude, click the appropriate checkbox to
clear it.
7. If you want to add more Event CRFs, click the Save and Add More Items button and repeat the
steps above to select the Event CRF Items to be included in the dataset definition.
8. To see the Items you have selected, click the View Selected Items link in the Info area of the Left
Panel.
9. If you want to select all items for all CRFs and Events, instead of selecting each Event and CRF,
click Select All Items in Study in the Info area of the Left Panel.
10. To select Metadata Attributes to be included in the dataset definition, such as Subject
Attributes, Events Attributes, Group Attributes, etc., click its link in the Info area of the Left
Panel.
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For example, clicking Subject Attributes opens the Create Dataset: Select Subject Attributes
page.
11. Select the checkbox for each Attribute to include.
12. If you want to include Attributes of a different type:
a. Click Save and Add More Items.
b. Repeat the two steps above to select additional Attributes to be included in the dataset
definition.
13. To see the Attributes that have been selected, click the View Selected Items link in the Info area
of the Left Panel.
14. After selecting all Items and Attributes that you want to be included in the dataset, click the
Save and Define Scope button.
The Create Dataset: Define Temporal Scope page opens.
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15. Set a date range for the dataset definition by following the onscreen instructions. The date you
specify is the Subject enrollment date. For example, if you have selected 2011 as the year for the
Beginning Date and Ending Date, the dataset will include all Subjects enrolled in 2011. After
specifying the date range, click the Continue button.
The Create Dataset: Specify Dataset Properties page opens.
16. Provide a Name and Description for the dataset definition and, if needed, change the Item
Status. You can also specify the ODM ID values, which you might use if you export the dataset to
an ODM file format.
17. Click Continue. The Create Dataset: Confirm Dataset Properties page opens.
18. Verify the Name and Description, and click Submit.
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A dataset definition has now been established and you can now generate and download a file containing
all data that meets the specified criteria.
6.1.2 Generating Datasets
After you create, edit, or select a dataset definition you are ready to generate the dataset file. Open the
Download Data page, and click Run Now next to the file format you want to generate. For more
information about the available file formats, see Dataset File Formats.
Note: If CRF masking functionality is being used, you cannot generate datasets that include CRFs that
have been masked from you.
A page appears that indicates your dataset is being extracted. ClinCapture maintains a queue of dataset
extracts, including scheduled jobs and dataset extracts initiated by other users. New data extract
requests are added to the end of this queue. After some time, depending on the size of the dataset and
the number of requests in the queue, the dataset file becomes available.
6.1.3 Viewing and Managing Dataset Definitions
You can search, edit, download and view dataset definitions for the current Study or Site.
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To view dataset definitions for the current Study or Site:
1. Select Tasks > Datasets to open the View Datasets page.
2. Click the View button in the Actions column next to the dataset definition you want to view.
To manage dataset definition files, use the following actions in the Actions column:
 Click the Export This Dataset button to generate and download the dataset file in a format you
select.
) to access the previously generated dataset files for the dataset
 Click the Export icon (
definition, or generate and download the dataset to a file.
) to make the dataset unavailable to other ClinCapture users.
 Click the Remove icon (
) to make a dataset available after it was previously removed.
 Click the Restore icon (
6.2 Downloading Datasets
A dataset must be generated before you can download it, see Generating Datasets for more
information.
To download a dataset for the current Study or Site:
1. Select Tasks > Datasets to open the View Datasets page.
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2. Click the Export this Dataset button next to the dataset you want to download. The Download
Data page opens, displaying the exported dataset files.
The file format is appended to the file name displayed in the table, along with additional details
such as the file size and date the file was generated.
Note: The Archive of Exported Dataset Files table includes only one dataset file for each
format for every dataset definition. When you generate a dataset file, whose format
already exists in the table, the file you generate replaces the existing file in the table. If
you want both files, download the existing file, and then generate the dataset and
download it using a different name, or edit the dataset definition and save it using a
different name and generate a new dataset for it.
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3. Click the Download icon (
) in the Actions column.
ClinCapture downloads the file in a .zip format. Extract the data using an unzip program such
as WinZip or 7-Zip, and save the data file (for example, the Excel .xls file) to a known location
on your local system.
For specific information about the file format you selected, see Dataset File Formats.
ClinCapture also sends an email to you containing a link to the dataset file, providing an alternative way
to access the file.
Open the file to find out if it contains the data that you expect. If not, you can edit the dataset definition
in ClinCapture and generate the dataset file again, see Editing Dataset Definitions. The data in the
dataset file reflects the ClinCapture database at the time the dataset file was generated, not at the time
you downloaded the file. The dataset file name includes the date and time the file was generated.
6.2.1 Browser Settings for Downloading Files
It is recommended that ClinCapture be configured to work over a secure SSL internet connection. If your
installation is configured this way, the URL you use to access ClinCapture begins with https://. To
download files from ClinCapture, your web browser must be configured to use an SSL connection.
If you use Internet Explorer as your web browser, you might have difficulty downloading files over SSL.
To resolve the problem, change the Internet Options for Internet Explorer:
1. In Internet Explorer, select Tools > Internet Options. The Internet Options dialog box opens.
2. Click the Advanced tab. The Advanced options page displays.
3. In the Security section, select the checkbox for Do not save encrypted pages to disk.
4. Click OK.
You should now be able to download ClinCapture files.
6.3 Editing Dataset Definitions
You can edit an existing dataset definition—that is, change the specified criteria—and either save the
edited definition with the same name to replace the existing dataset, or with a new name to create a
new copy and maintain the existing dataset definition without changes. Once you have modified the
dataset definition, you can generate and download a dataset file for the new definition. The steps to
edit a dataset definition are very similar to creating a new dataset definition. If you need more details
than what are included in these steps, refer to Dataset Creation.
Note: If CRF masking functionality is being used, editing a dataset that contains CRFs that have been
masked from you will automatically be excluded from the dataset.
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To edit a dataset definition:
1. Select Tasks > Datasets > View Datasets. The View Dataset page opens, listing all the dataset
definitions for the current Study or Site.
2. For the dataset definition you want to modify, click the Edit icon in the Actions column.
The Edit Dataset page opens for the dataset definition you selected, listing all CRFs Items that
were covered. It also lists all possible Attributes, initially marked in the checkboxes that were
selected for the dataset definition.
The Edit Dataset page lists the CRF Items in a table, with checkboxes selected for any of the
Items that are already specified for the dataset.
3. To remove any of the existing criteria, clear the checkbox for the Item or Attribute, and click the
Add or Remove Items button.
4. To add Attributes, select the checkbox for each Attribute that you want to add, and click Add or
Remove Items.
5. To add CRF Items:
a. In the Info area of the Left Panel, click the Event whose CRF you want to add. The panel
shows the CRFs associated with the Study Event.
b. Click the CRF that contains the Items you want to add.
6. Select Items from the CRF that you want to include in the dataset.
7. Click Save.
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8. To continue adding CRF Items, click the Add More Items button and repeat the steps to add CRF
items.
At any point, while you are modifying the dataset, you can click View Selected Items in the Info
area of the Left Panel to see all selected Items and Attributes.
9. After changing the items contained in the dataset, click the Save and Define Scope button. The
Edit Dataset: Define Temporal Scope page opens.
10. Set a date range for the dataset definition by following the onscreen instructions, and click the
Continue button. The Edit Dataset: Specify Dataset Properties page opens, showing the name
and description of the existing dataset definition.
11. To revise the existing dataset definition, do not change the Name and Description. To maintain
the existing dataset definition and create a copy that reflects your changes, provide a new
name, and click Continue. The Edit Dataset: Confirm Dataset Properties page opens.
12. Verify the Name and Description, and click Submit. The Download Data page opens. You can
now generate and download a file containing all the data matching the criteria you specified in
the dataset definition.
6.4 Dataset File Formats
This section provides information about the dataset file formats you can generate and download using
ClinCapture.
ClinCapture’s standard tabular (non-CDISC XML) data export formats are HTML, tab-delimited, Excel,
and SPSS. The HTML, tab-delimited, and Excel formats each contain two tables: a header table that
contains reference information about the dataset contents, and a data table. The SPSS data export
format has a data table similar in structure and format to the others, but does not have a header table.
Instead, it includes a separate .sps syntax file that describes the dataset.
The format you choose depends on how you intend to use the extracted data. The CDISC ODM formats
are the most robust, including not only the data but also the metadata. HTML and Excel formats are the
easiest for a person to read.
Variable names in the downloaded files use the following format:
ItemName_EventNumber_CRFNumber
6.4.1 Header Table Format
The header table includes the following information:
 Dataset name
 Dataset description
 Study name
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




Protocol ID–the Study protocol ID
Date–the date the dataset was created
Subjects–the number of Subject records in the dataset
Study Event Definitions–the number of Study event definitions included in the dataset
For each of the included Study event definitions, the name of the event definition plus an
identifier which is used to reference the event definition in the data table
For each of the included CRFs, the name of the CRF plus an identifier that is used to reference the CRF in
the data table must be there.
6.4.2 Variable Naming Convention
To avoid duplication and confusion among the data points collected in a Study, certain identifiers and
ordinal numbers must be appended to each variable name. These variable names can be used in
multiple CRFs across multiple Events. These appendages help identify the Event, CRF, and Item that the
value was collected in.
Identifiers are defined in the header table for tab-delimited, HTML, and Excel formats, while a separate
syntax (.sps) file is used for SPSS. Identifiers use the following scheme:
 E1–The E specifies that the appendage represents an event. The 1 specifies which event the
variable is from, as defined in the header table. If the event is repeating, it would be
represented as E1_1, E1_2, E1_3, and so on.
 C1–The C specifies that the appendage represents a CRF. The 1 specifies which CRF the variable
is from, as defined in the header table.
For repeating events and repeating groups, additional information must be provided to identify which
occurrence of the event or which repeat of the group the item value comes from. This is done by
appending _X, where X is the ordinal or repeat number. As an example, an item called DEMO appearing
in the third occurrence of a repeating event, and the fifth repeat of the group is identified in the
following way.
DEMO_E1_3_C1_5
For an item in a repeating event, but not part of a repeating group, the variable is identified in the
following way:
DEMO_E1_3_C1
6.4.3 Supported Extract Formats
ClinCapture supports exporting data in HTML, Excel, SPSS, and CDISC ODM formats.
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HTML Format
You can download and view a dataset file in HTML format (.html file).
When viewing the HTML file, you can view the metadata for an Item by clicking its column header.
Excel Spreadsheet Format
When you download to the Excel Spreadsheet Format, the dataset is an .xls file.
SPSS Format
When you select the SPSS format, the extracted .zip file contains two different files: a tab-delimited
data file (.dat), and an SPSS data definition script file (.sps).
To access the data, save the .dat and .sps files to the same location, and open the .sps file in the
IBM SPSS program. If both these files are not in the same location, change the FILE location in the .sps
file to point to the physical location of the .dat file. From SPSS, select Run > All to load the data into the
application.
You can preview the .dat file by opening it in a text editor.
CDISC ODM Formats
When you select one of the CDISC ODM formats for the dataset, ClinCapture exports the dataset to an
.xml file that complies with the Operational Data Model (ODM) of the Clinical Data Interchange
Standards Consortium (CDISC) standard. These are the different parameters for the available ODM
formats:
 1.3 or 1.2: Refers to the version of the ODM specification.
 With extensions: Includes ClinCapture entities that are not part of the ODM specification, such
as the Subject Group Class and its attributes.
 Full: Includes Discrepancy Notes and the Audit Log.
CDISC ODM is a vendor-neutral, platform-independent format for interchange and archive of data
collected in clinical trials. The model represents Study metadata, data, and administrative data
associated with a clinical trial. The ODM has been designed to be compliant with guidance and
regulations published by the FDA for computer systems used in clinical trials.
The ODM model categorizes clinical Study data into several kinds of entities, including Subjects, Study
Events, CRFs, Item Groups, Items, and Annotations. The Study metadata describes the types of Study
events, forms, item groups, and items that are allowed in the Study. The clinical data of a Study typically
has many actual entities corresponding to the definitions described in the metadata.
Like any XML file, an ODM file consists of a tree of elements that correspond to entities. Each element
consists of required attributes and optional attributes. An ODM file type must be either Snapshot or
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Transactional. A Snapshot file shows the current state of the included data. A Transactional file shows
both the latest state and (optionally) some prior states of an included entity. An ODM file has a
Granularity attribute which describes the coverage information of the ODM file.
The ODM file consists of two parts: metadata followed by Subject data. The metadata provides certain
identifiers for the Study, units (as defined when the CRFs were created), Event information, CRF
information including Item Groups and Items with information about validations, and user account
information. The Subject data provides Subject information, Event information, CRF information, and
their respective values.
For more details about the ODM specification and its use in ClinCapture, see CDISC ODM Representation
in ClinCapture in the ClinCapture Programmer’s Guide and the ODM Final Version 1.3 for
Implementation at the CDISC website.
6.4.4 SAS Format via CDISC ODM
ClinCapture does not export a dataset directly into a SAS-specific format. However, you can export a
dataset to the CDISC ODM 1.2 format, which can be imported into some versions of SAS.
SAS users running Release 8.2 or later can run the SAS CDISC Procedure, PROC CDISC, to load CDISC
ODM 1.2 XML documents into SAS.
For more detailed instructions, see Base SAS: PROC CDISC at the SAS support website. The following
papers from the Pharma SAS User Group (PharmaSUG) may also be helpful:
 Valkanova, E and Droll I, Exploring SAS® PROC CDISC Model=ODM and Its Limitations,
Proceedings of PharmaSUG2010.
 Valkanova, E and Droll I, Exploring SAS® PROC CDISC Model=ODM and Its Undocumented
Parameters, Proceedings of SESUG2009.
6.5 Special Permissions
System Administrator, Study Administrator, Study Monitor, Site Monitor, and Investigator user roles can
access the Extract Data module.
Only System Administrators and Study Administrators can delete, remove, or restore Dataset Definitions
they did not create.
For information about features in the module, see Extract Data.
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6.6 Annotated CRFs
An annotated CRF is a blank CRF that has been marked, or annotated, with the CRF item name for each
item on the CRF.
To generate an annotated CRF:
1. Select Tasks > CRFs, then click the Annotate CRF icon to the right of the CRF version.
Alternatively, from the View CRF Details page, click the Annotate CRF icon to the right of the CRF
version.
2. The annotated CRF displays.
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Each CRF field is annotated with the CRF name highlighted in yellow with green text; each table
annotation is highlighted in yellow with orange text.
If Study Parameter, SAS Name Annotation, is answered Yes, the CRF will be annotated in SAS
format. SAS field names can be eight characters long. If the CRF item name is longer than eight
characters, the annotation will be truncated to display the first eight characters only.
3. If the CRF has multiple pages, you can click the page tab headings to access the annotated CRF
for each page.
4. If desired, use your browser’s print functionality to print the annotated CRF for your records.
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7 GLOSSARY
Audit Log
A system feature that maintains a historical record of key actions related to a Study Subject made in
the ClinCapture database (this is part of 21 CFR Part 11 compliance).
Calendared Event
A Calendared Event can be automatically scheduled when a reference visit is completed. This is
typically used for follow-up events that must occur within a predefined period of time after the
treatment occurred.
CRF (Case Report Form)
A form that contains Study Event information for a Study Subject. CRFs are defined using Excel
spreadsheets and are presented in a web interface that is easy to complete. See also Defined CRF.
Dataset Definition
Criteria (metadata) specified to create a dataset.
Dataset
A collection of data and metadata from records, such as CRFs and Study Events, that match a
Dataset Definition. A Dataset is exported to a file, whose format can be selected, for use in other
applications.
Defined CRF
An Excel spreadsheet composed of Pages, Item Groups, and Items that you create for use in
ClinCapture. A Defined CRF can have multiple versions. You assign it to one or more Study Events in
one or more Studies.
Delete
A delete action completely removes the information from the ClinCapture system. Deleted
information cannot be restored, although the audit log tracks the deletion action. Nearly all
information in ClinCapture is removed rather than deleted because removed information can be
restored. See also Remove.
Discrepancy Notes
A means of conveying clarifying questions about CRF Items whose value, condition, level of detail,
etc., do not conform to expectations.
Dynamic Groups
In ClinCapture, specific Study Events can be associated with a Dynamic Group. For example, to
create multiple treatment arms, different Dynamic Groups can be configured with different Study
Events.
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Enrollment
Adding a Subject to a Study. The ClinCapture Enrollment Date is when the Subject is added to a
ClinCapture Study.
Event
See Study Event.
Group
See Item Group and Subject Group Class.
Item
Also known as a Data Item. For example, a single question in a CRF. Items have metadata attached
to them. Items can have multiple Edit Checks attached to them through either metadata or Rules.
Item Group
A grouping of Items in a CRF. Item Groups can be repeating—for example, recording multiple
Adverse Events on one form—or non-repeating.
Job
In ClinCapture, you can schedule Export Data Jobs and Import Data Jobs to run automatically at a
specified frequency.
Module
A group of related features in ClinCapture, such as the Submit Data module. Access to a module is
based on a user role and user type.
Null Values
The string that represents null values for an Event Definition—for example, N/A for Not Applicable.
The string is considered as a reserved word for the CRF.
Person ID
The unique identifier for a Subject that references the Subject across all Studies in the ClinCapture
system. It may be required or optional, depending on how the Study was set up.
Randomization
ClinCapture offers block randomization, which differs from simple randomization as it is designed to
randomize Subjects into groups that result in equal sample sizes. This method ensures a balance in
sample size across groups over time. Multi-stratification variables are supported.
Remove
A remove action makes the information unavailable in the ClinCapture system. You can restore
information that has been removed to make it available again. Most information in ClinCapture is
removed so that it can be restored, although, in some cases, information can be deleted. See also
Delete.
Roles
Categories for users in ClinCapture that determine the tasks available to them in the system.
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Rules
Customized methods used to trigger actions on records such as the automatic generation of a
Discrepancy Note or email. Rules are stored in XML files. They can be defined in an XML file and
uploaded to ClinCapture, or directly defined in ClinCapture using the Rule Studio.
Secondary ID
An optional identifier given to a Subject. It is often a legacy identifier like a patient record number
used to link the Subject to another system or workflow.
Sites
Locations where the Study has taken place, although they do not have to be physical locations. You
can work with ClinCapture at the Site level, which limits the view of the Study to a specific Site.
Study
In ClinCapture, a clinical trial or clinical research project, including all the metadata and data for it.
Study Event
A visit or encounter in the Study where data is captured or created. A Study Event packages one or
more case report forms (CRFs). It is also referred to as an Event.
Study Event Definition
Describes a type of Study Event, and includes the CRFs to be used.
Study Level
An aggregated view of a Study with information and data for all Sites in the Study.
Study Subject
A person added to a specific Study in ClinCapture. Also referred to generally as a Subject, but keep in
mind that one Subject can exist across several Studies. Therefore, we use the term Study Subject to
refer to one Subject enrolled in one Study.
Subject Group Class
An optional feature used to categorize Subjects in a Study. Often, Subject Group Classes are used for
different treatment arms or options. This is especially relevant for ClinCapture's Randomization and
Dynamic Group features.
Study Subject ID
A unique identifier generated either manually or by the system when adding a Subject to a Study.
Subject
A person who participates in a Study.
Subject Casebook
All CRFs for all Events for a Study Subject.
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User
The Person using the ClinCapture software. A user can have one or more Roles in one or more
Studies or Sites.
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