1. Introduction
    1. Referencing Captivate
    2. License Information
    3. Typographical Conventions
    4. Document Organization
    5. Target Audience
  2. Key Concepts
    1. Functional Overview
    2. Typical EDC Workflow
    3. Color Themes
    4. Interface Language
    5. Captivate Modules
    6. Protecting PHI Data
    7. Changing the Current Scope
    8. One-Click Access™
  3. Getting Started
    1. How to Login
      1. Login Problems
      2. Changing Your Password
      3. Updating Your User Profile
      4. Logging Out
    2. Captivate Icons
      1. Status Icons
      2. Frequently Used Icons
      3. Other Icons
    3. Home Page Framework
      1. Home Page Header
      2. Navigation Bar
      3. Side Panel
      4. Main Body
      5. Home Page Footer
    4. Last Row Accessed
  4. Captivate Live Tasks
  5. Add Subject
    1. Add Subject from Subject Matrix
    2. Add Subject from Tasks Menu
    3. Add a Subject to Multiple Studies
    4. Administer Subjects
  6. Schedule Events
    1. Calendared Event
    2. Event Status
    3. Edit Event
    4. View Event
    5. View Events
  7. Subject Matrix
    1. Subject Matrix Pop-up
    2. Subject Matrix Pop-up Action Icons
    3. Locking and Unlocking a Subject Record
    4. Dynamic Groups
    5. Submitting Data for a Subject
    6. Show More Subject Information
    7. Finding and Organizing Data
    8. Study Subject Record
  8. Entering CRF Data
    1. Manual Data Entry
    2. Partial Data Entry
    3. Subject Randomization
    4. CRF Unavailable
    5. Double Data Entry
    6. CRF Status
    7. Modifying a Previously Saved CRF
    8. Data Entry Timeout
  9. Import Data
    1. Data Import Options
    2. Data File Import
    3. Data File Format
    4. Data File Validation
  10. Notes and Discrepancies
    1. Discrepancy Note Types
    2. Discrepancy Note Status
    3. Creating Discrepancy Notes
    4. Viewing a Discrepancy Note
    5. Updating a Discrepancy Note
    6. Managing Discrepancy Notes
    7. Finding and Organizing Discrepancy Notes
    8. Downloading Discrepancy Notes
    9. Generating Discrepancy Correction Forms (DCFs)
  11. Source Data Verification
    1. Verifying Source Data
    2. Customizing the View
    3. Finding and Organizing SDV Data
    4. Viewing SDV Status
    5. Resetting SDV Status
  12. Electronic Signatures
  13. Study Audit Log
    1. Viewing Audit Logs for a Subject
    2. Changes Tracked in the Study Audit Logs
    3. Exporting Study Audit Logs for a Subject
  14. Email Log
  15. Medical Coding
    1. Coding a Medical Term
    2. Medical Coding Status
    3. Resetting Medical Coding Status
  16. Evaluate CRF Data
    1. CRF Evaluation Widget
    2. Performing CRF Evaluation
  17. Extract Data
    1. Datasets
      1. Defining a Dataset
      2. Generating Datasets
      3. Viewing and Managing Dataset Definitions
      4. Downloading Datasets
      5. Editing Dataset Definitions
      6. Dataset File Formats
        1. Header Table Format
        2. Variable Naming Convention
        3. Supported Extract Formats
      7. Jobs
        1. Import Job
        2. Export Job
    2. Casebooks
  18. GLOSSARY

1.Introduction

This document describes the features of Captivate 3.0, an EDC system developed by ClinCapture. You access Captivate using a web browser. Supported browsers include: Microsoft Edge, Mozilla Firefox 18 or newer,  Google Chrome 24 or newer and Apple Safari 3 or newer.

 

Suggest edit
Last updated on January 2, 2019

1.1.Referencing Captivate

If you used Captivate to capture data for your study, you can reference it as follows:

“Data collection and management for this study was performed using Captivate 3.0, an EDC system developed by ClinCapture.”

Suggest edit
Last updated on July 30, 2018

1.2.License Information

Captivate 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 in the Captivate software distribution.
Suggest edit
Last updated on May 25, 2018

1.3.Typographical Conventions

Sample 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 Captivate.
Submit Bold font indicates verbatim text from Captivate, often used to identify a button, icon, text or field.
Home Italics font indicates a webpage, document name, or emphasis.
Suggest edit
Last updated on May 25, 2018

1.4.Document Organization

After the Introduction, Key Concepts, and Getting Started sections, the body of this document is organized according to the modules in the Captivate Tasks menu, excluding the Study Setup and Administration modules, which are covered in the Captivate Build User’s Guide:

  • Submit Data
  • Monitor and Manage Data
  • Extract Data
  • Administration
Suggest edit
Last updated on July 30, 2018

1.5.Target Audience

This document is intended for clinical research professionals involved in data collection, monitoring, management, and data exports. As such, it does not cover advanced configuration and programming topics that are fully discussed in the Captivate Build User’s Guide.

Suggest edit
Last updated on July 30, 2018

2.Key Concepts

This section introduces the key concepts embodied in Captivate, presents a typical Electronic Data Capture (EDC) workflow, and describes the role-based user interface and functionality.

Suggest edit
Last updated on May 25, 2018

2.1.Functional Overview

Captivate provides a comprehensive set of role-based features to perform EDC during clinical trials, including:

  • 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
  • Optionally 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
Suggest edit
Last updated on May 25, 2018

2.2.Typical EDC Workflow

The figure below illustrates a typical EDC workflow in Captivate from Study configuration, to data locking.

Typical EDC Workflow in Captivate

2016-03-16_17-03-55

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 Captivate is integrated with a CTM system. Or discrepancy management may not be enabled, or Source Data Verification not required.

Suggest edit
Last updated on May 25, 2018

2.3.Color Themes

Captivate can be configured at the instance level with different colors. There are five color themes you can choose from: Blue, Dark Blue, Green, Violet and Royal Purple.

Suggest edit
Last updated on May 25, 2018

2.4.Interface Language

Captivate’s graphical user interface can be configured to display in different languages.

There are four languages you can choose from: English, Russian, Spanish (Latin America), and Chinese.

Contact your study administrator to change the language, if needed.

Contact ClinCapture support if additional languages are required.

Suggest edit
Last updated on May 25, 2018

2.5.Captivate Modules

The tables below list the Captivate Modules and main tasks available for each user role. When your user type or role is not allowed to access a particular Captivate Module or task, it does not appear in the Tasks menu.

Study-level user roles:

User Role Captivate Module Tasks
Study Administrator Submit Data
  • Subject Matrix
  • Notes & Discrepancies
  • Import Data
  • Schedule Event
  • View Events
Monitor and Manage Data
  • Source Data Verification
  • Study Audit Log
  • Code
  • Evaluate CRF
  • Sign
Extract Data
  •  Datasets
  • Casebook
Administration
  • Jobs
  • Subjects
  • Email Log
Other
  • Update Profile
  • Help
  • Support
  • Log Out
  • Forums
  • About
User Role Captivate Module Tasks
Study Monitor Monitor and Manage Data
  • Subject Matrix
  • View Events
  • Source Data Verification
  • Notes & Discrepancies
  • Study Audit Log
  • Reports
Extract Data
  •  Datasets
Other
  • Update Profile
  • Help
  • Support
  • Log Out
  • Forums
  • About
User Role Captivate Module Tasks
Study Sponsor Submit Data
  • Subject Matrix
  • View Events
  • Notes & Discrepancies
Extract Data
  •  Datasets
  • Casebook
Other
  • Update Profile
  • Help
  • Support
  • Log Out
  • Forums
  • About
User Role Captivate Module Tasks
Study Coder Monitor and Manage Data
  • Code
  • Notes & Discrepancies
Other
  • Update Profile
  • Help
  • Support
  • Log Out
  • Forums
  • About
User Role Captivate Module Tasks
Study Evaluator Monitor and Manage Data
  • Notes & Discrepancies
Other
  • Update Profile
  • Help
  • Support
  • Log Out
  • Forums
  • About

Site-level user roles:

User Role Captivate Module Tasks
Investigator Submit Data
  •  Subject Matrix
  •  Add Subject
  •  Notes & Discrepancies
  •  Schedule Event
  •  View Events
  •  Import Data
Extract Data
  •  Datasets
Other
  • Update Profile
  •  Help
  • Support
  • Log Out
  • Forums
  • About
User Role Captivate Module Tasks
Clinical Research Coordinator Submit Data
  • Subject Matrix
  • Add Subject
  • Notes & Discrepancies
  • Schedule Event
  • View Events
  • Import Data
Other
  • Update Profile
  • Help
  • Support
  • Log Out
  • Forums
  • About
User Role Captivate Module Tasks
Site Monitor 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
Suggest edit
Last updated on July 30, 2018

2.6.Protecting PHI Data

Data marked PHI in the form designer in Captivate Build, for example a subject’s date of birth, is masked with black circle characters when it is accessed by Study-level users.  PHI data is masked to study-level users when they:

  • View the data within the CRF.
  • Source data verify a CRF.  If PHI data must be SDV-ed, it must be done by a Site Monitor.
  • Export the data.  Unmasked PHI data can only be exported by a CRC,  an Investigator or a Site Monitor user.
  • Query the data.  All PHI data is masked in the query and in the Notes and Discrepancies page.
  • Access the audit log.  Before and after values are masked.

To enable PHI data protection:

  1. Selecting the eSource add-on in Captivate Build  will automatically enable PHI data protection.
  2. PHI data protection can also be enabled by a Study Administrator in the Study Parameter Configuration, under Study Build.
  3. Once enabled, PHI data protection cannot be disabled by a Study Administrator.  To do so, please contact ClinCapture Support.
Suggest edit
Last updated on July 30, 2018

2.7.Changing the Current Scope

Captivate limits the tasks and data 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 Site link, just above the Navigation Bar.
  2. Select the desired Study or Site. Site names are indented under the Study name.
  3. Click Submit to confirm your scope change.

Change current Study/Site page

2016-04-03_10-27-52

To automatically select a Study when you login, set it as the Default Current Study in your User Profile.

Suggest edit
Last updated on August 4, 2018

2.8.One-Click Access™

The Captivate 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.

One-Click Access popup

2016-04-03_10-35-41

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.

Suggest edit
Last updated on May 25, 2018

3.Getting Started

This section shows you how to get started with Captivate. It explains how to login, reset your password, change your user profile, and logout.

Suggest edit
Last updated on May 25, 2018

3.1.How to Login

To access the Captivate Login page, use the URL provided in your CRF Completion Guidelines, or through your Study Administrator. When you build your study, you can configure the study description that displays on the login screen. For example, you can use the study name, or a description of the instance.

Please note that your company logo may appear instead of the Captivate logo at the bottom of the Login page.

Captivate login page

Useful resource links available at the lower left of the page include:

  • About: Display the Captivate 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.
  • Forums: Open the Forum page where users can discuss topics about Captivate.

The Captivate 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. Note that Captivate user names are case sensitive.

If the Study (or Site) you are working with is locked or frozen, that is they are no longer accepting data entry, a message indicating such will appear in the left panel.

Suggest edit
Last updated on May 25, 2018

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.
    2016-04-03_11-45-04
  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.

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 a message to [email protected]).

Note that this feature is only available after your first successful login, where you have created your challenge question/answer.

Suggest edit
Last updated on May 25, 2018

3.1.2.Changing Your Password

Your new password must meet the password policy set by your Administrator and may require a combination of uppercase 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.
Suggest edit
Last updated on May 25, 2018

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.
    2016-04-03_12-08-27
  2. Make the necessary changes to your name, email address, time zone, default active Study, password challenge question, password, and/or phone number, and click Continue.
    2016-04-03_12-11-16
  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.

Note: All dates are saved on the server using the UTC-0 timezone and the date/time stored is interpreted and displayed according to the timezone specified in the user profile. Therefore, setting your timezone is very important.

Suggest edit
Last updated on May 25, 2018

3.1.4.Logging Out

Click the Log Out link to exit Captivate.

A user may only be logged into one and only one Captivate instance at any time. If you have a browser window open and attempt to login a second time using another browser/window, you will be logged out of your first connection.

Suggest edit
Last updated on May 25, 2018

3.2.Captivate Icons

Captivate 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 Captivate color scheme. For details, see Color Themes.

 

Suggest edit
Last updated on May 25, 2018

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
 2016-03-20_12-03-38 Not started
 2016-03-20_12-04-30 Scheduled
Partial Data Entry
 2016-03-20_12-06-13 Data Entry Started
 2016-03-20_12-07-10 Stopped
 2016-03-20_12-07-58 Skipped
 2016-03-20_12-08-44 Completed
 2016-03-20_12-09-26 Initial Data Entry Completed
  Partial Double Data Entry
   Double Data Entry Started
 2016-03-20_12-10-13 Coded
 2016-03-20_12-14-34 Not Coded
 2016-03-20_12-15-25 Source Data Validated (SDV)
 2016-03-20_12-16-03 Signed
 2016-03-20_12-16-50 Locked
 2016-03-20_12-17-31 Removed
Suggest edit
Last updated on May 25, 2018

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.

Icon Meaning Description
2016-03-20_12-23-21 View Click to see the details of the function associated with the icon.
2016-03-20_12-24-49 Edit Click to change the descriptions associated with the function.
2016-03-20_12-25-31 Set Role Click to assign roles for the User within the Study.
2016-03-20_12-26-16 Remove Click to remove a function.
2016-03-20_12-27-11 Lock Click to lock subject records.
2016-03-20_12-28-11 Unlock Click to unlock subject records.
2016-03-20_12-29-04 Restore Click to restore a function that was previously removed. (The icon appears only after a function has been removed.)
2016-03-20_12-29-39 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.
Suggest edit
Last updated on May 25, 2018

3.2.3.Other Icons

Icon Meaning
2016-03-20_12-34-53 Administrative editing
2016-03-20_12-35-32 Archive
2016-03-20_12-37-48 Calendar
2016-03-20_12-38-44 Create new
2016-03-20_12-39-30 Delete (cannot be undone)
 2016-03-20_12-41-02 Discrepancy Note: Add
 2016-03-20_12-57-07 Discrepancy Note: New

Discrepancy Note: New DCF

 2016-03-20_12-58-23 Discrepancy Note: Not Applicable (has no status)
 2016-03-20_12-59-33 Discrepancy Note: Closed
 2016-03-20_13-00-53 Discrepancy Note: Updated
2016-03-20_13-01-40 Download
2016-03-20_13-06-37 Export/Test/View in context

Annotated CRF

Upversion CRF

Reassign Subject

2016-03-20_13-08-45 Help
2016-03-20_13-12-13 Remove
2016-03-20_13-12-45 Un-archive

Unlock

Suggest edit
Last updated on May 25, 2018

3.3.Home Page Framework

The Captivate 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

Captivate Home page

Suggest edit
Last updated on May 25, 2018

3.3.1.Home Page Header

The Home page header is the top area, just above the Navigation Bar. It contains:

  • 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 Captivate and their assigned role, such as Study Monitor (CRA).
  • Flag: Indicates the language locale for the system.
  • Log Out: Ends your Captivate session.
Suggest edit
Last updated on May 25, 2018

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 (2016-03-20_13-36-33) to the right of the section name to expand a section and show its information, or click the minus sign (2016-03-20_13-37-29) to collapse a section and hide its information.

  • Alerts and Messages: Displays alerts and message when you perform actions in Captivate. 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 Captivate. For more information, click the Help button (2016-03-20_13-38-16) 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.
Suggest edit
Last updated on May 25, 2018

3.3.4.Main Body

The Main Body of the Home page 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.

Just above the interactive dashboards is a link to the unresolved discrepancies assigned to the current user, as well as a count of the number of those unresolved discrepancies. Click the link to go to the Notes & Discrepancies page to work with the unresolved discrepancies.

  • Coding Progress: Provides a graphical presentation of the number of items that have been coded and the number of items left to be coded. Hover your mouse over the sections of the bar graph to the see the count of each section. Click on a section of the last reported progress bar to display the corresponding information. The other progress bars are shown for historical purposes only.
  • CRFs Evaluation Progress: Provides a graphical presentation of the number of CRFs ready for evaluation and the number of CRFs for which evaluation is completed. Hover your mouse over the sections of the bar graph to the see the count of each section. Click on a section of the last reported progress bar to display the corresponding information. The other progress bars are shown for historical purposes only.
  • Enrollment Progress: Provides a graphical presentation of the number of subjects with the following statuses: Available, Removed, Signed, Locked. Hover your mouse over the sections of the bar graph to the see the count of each section. Click on a section of the last reported progress bar to display the corresponding information. The other progress bars are shown for historical purposes only.
  • Enrollment Status Per Site: Provides a graphical presentation of the number of subjects with the following statuses for each site: Available, Removed, Signed, Locked. Click any of the sections in the pie chart to go to the Subject Matrix for the corresponding status. Hover your mouse over the statuses in the legend to see the counts and percentages for each enrollment status.
  • Event Status Details: 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. Click any of the sections in the bar graph to go to the Subject Matrix for the corresponding status. Hover your mouse over the statuses in the legend to see the counts and percentages for each event status.
  • 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. Click any of the sections in the pie chart to go to the View Events page for the corresponding status. Hover your mouse over the sections of the pie chart to the see the count and percentage of each event status.
  • My Discrepancies: Provides a graphical presentation of the number of new, updated, and closed discrepancies for the current Study or Site. Click any of the bars to go to the Notes & Discrepancies page. Hover your mouse over the statuses in the legend to see the percentage of your discrepancies that are in each status.
  • Notes and Discrepancies Per CRF: Provides a graphical presentation of the number of notes/discrepancies with the following statuses for each CRF in the study: Notes, New, Updated, Closed. Click any of the bars to go to the Notes & Discrepancies page.
  • Source Data Verification Progress: Provides a graphical presentation of the number of CRFs that are available for source data verification and those that have been source data verified. Hover your mouse over the sections of the bar graph to the see the count of each section. Click on a section of the last reported progress bar to display the corresponding information. The other progress bars are shown for historical purposes only.
  • 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. Click any of the sections in the pie chart to go to the Subject Matrix for the corresponding status. Hover your mouse over the sections of the pie chart to the see the count and percentage of each subject status.

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.

To customize the home page:

  1. From the bottom of the Home page, click Customize Home Page.
    The Available Widgets panel opens.

    • Click Hide to hide the Available Widgets panel.
    • Click Show to show the Available Widgets panel.
  2. Do any of the following:
    • Drag and drop any of the widgets from the Available Widgets panel to add it the main body.
    • Drag and drop any of the widgets on the main body to rearrange them.
    • Click the remove button (2016-04-09_16-00-25) to remove a widget from the main body. Alternately, drag and drop the widget to the Available Widgets panel.
  3. Click Submit.
    Note:The widgets that are available to you depend on your role, as well as if you are at the study or site level.
Widget System Administrator (root) Study Administrator Study Monitor Study Sponsor Site Monitor Study Coder Study Evaluator Investigator Clinical Research Coordinator
 Coding Progress 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51
CRFs Evaluation Progress 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51
Enrollment Progress 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51
Enrollment Status Per Site 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51
Event Status Details 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51
Events Status Summary 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51
My Discrepancies 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51
Notes and Discrepancies Per CRF 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51
Source Data Verification Progress 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51
Subject Status Summary 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51
Suggest edit
Last updated on May 25, 2018

3.4.Last Row Accessed

As you perform actions in Captivate, 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 displayed in Captivate.

For example, in the following image, the last action taken on the Subject Matrix page was for Subject ID 004, so that row is highlighted in orange.

Note: This row will change if you hover over another row.

2016-04-03_12-34-44

Suggest edit
Last updated on May 25, 2018

4.Captivate Live Tasks

Captivate Live tasks can be accessed from the Navigation Bar, or the Tasks Menu.  The Tasks Menu is organized in the following menu sections:

  • Submit Data
  • Manage & Monitor Data
  • Extract Data
  • Administration

The following clinical tasks are available in Captivate Live, under the Tasks Menu.

Task Description
Add Subject  Create a new subject record
Subject Matrix  View information about each Subject in a Site from the Subject Matrix.
View Events View scheduling 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.
Sign Apply eSignature to clinical data and monitor progress.
Datasets Create and manage dataset to extract data in various formats.
Import Data Import data from an ODM XML file.
Casebooks Generate subject casebooks and download them.
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.
Evaluate CRF Allows a second data entry person to evaluate the data submitted.  If data is changed, a discrepancy is generated to be adjudicated by a Study or Site Monitor.

Refer to the table below to determine the user role’s permission to access a given task.

X – Full access

X – Limited access, see below

X – No access

Tasks Menu Task User Role
Study Sponsor Study

Admin

Study Monitor Study Coder Study Evaluator Clinical Research

Coordinator

Site Monitor Investigator
Submit Data

Add Subject

X X X X X X X

X

Schedule Events

X

X X X X X X

X

Enter CRF Data

X

X X X X X X

X

Subject Matrix

X

X X X X X X

X

View Events

X

X X X X X X

X

Import Data

X

X X X X X X

X

Manage & Monitor Data Notes and Discrepancies

X

X X X X X X

X

Study Audit Log

X

X X X X X X

X

Source Data Verification

X

X X X X X X

X

Sign

X X X X X X X

X

Code X X X X X X X

X

Evaluate CRF 

X

X X X X X X

X

Extract Data Datasets

X

X X X X X X

X

Casebooks

X X X X X X X

X

Administration Jobs

X

X X X X X X

X

Subjects

X

X X X X X X

X

Email Log

X

X X X X X X X

These access restrictions apply to the following tasks:

Tasks Menu Task

User Role

Study Sponsor Study Admin Study Monitor Study Coder Study Evaluator Clinical Research Coordinator Site Monitor Investigator
Submit Data Subject Matrix Read only access. Read only access.  Can only enter data in CRFs to be evaluated. Site level access.

Cannot remove/restore and lock/unlock Subjects.

Cannot reassign Subjects to another Site.

Site level access.

Read only access.

Site level access.

Cannot remove/restore/lock/unlock subject.

Cannot reassign Subject to another Site.

Manage & Monitor Data Notes & Discrepancies Read only access. Can only open queries related to coding.

Can only close queries they created

Cannot open or close queries. Site level access.

Cannot open or close queries.

Site level access. Site level access.

Cannot open or close queries.

Sign Read only access. Read only access. Read only access.
Extract Data Datasets Site level access. Site level access.
Casebook Site level access. Site level access.
Suggest edit
Last updated on August 4, 2018

5.Add Subject

The only user role allowed to add Subjects is the Clinical Research Coordinator (CRC) and the Investigator. To add a Subject to a Study, click the Add Subject link in the Navigation Bar or the Tasks Menu ( Tasks > Add Subject).

When you add a Subject to a Site, you create a Study Subject record. There are two ways to add a Subject:

  • 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, the Site must exist and the Study status must be Deployed.   The Study Administrator can later change the Site assignment.

After adding a Subject, you can edit the information in the Subject record from the Subject Matrix. See Study Subject Record.

Note:

  • Check your study status if you do not see the Add Subject link in the Navigation Bar.
Suggest edit
Last updated on August 4, 2018

5.1.Add Subject from Subject Matrix

Perform the following steps to add more than one Subject and schedule them for a Study Event:

  1. In the Subject Matrix, click the Add New Subject link. The Add New Subject page opens.
    2016-04-03_14-51-48
  2. 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.

    1. 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
    2. Enter the Secondary ID. This is another unique identifier for the Subject. This field may be labeled differently or be hidden.
    3. Enter the Person ID. This is another unique identifier for the Subject. This field may be hidden.
    4. 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.
    5. Select the Sex. This field may be labeled differently or be hidden.
    6. 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.
    7. Select the Group(s) from the drop-down list, if any Subject Group Classes were defined in the Study setup.

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 first CRF in the first event in the study.
  • 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.
Suggest edit
Last updated on May 25, 2018

5.2.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.

Suggest edit
Last updated on May 25, 2018

5.3.Add a Subject to Multiple Studies

After adding a Subject to a Study, the Subject can participate in other Studies. Simply add the Subject to each Study, using the same Person ID. When you add a Subject to a second or subsequent Study, Captivate 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.

Suggest edit
Last updated on May 25, 2018

5.4.Administer Subjects

Information related to a Subject, such as the Date Of Birth, and Person ID can be managed only by the Study Administrator.

To administer Subject information:

  1. Click Tasks  Menu -> Subjects
  2. The Administer Subjects page open.

To update Subject Information,

  1. From the Administer Subjects page, locate the desired subject then click the Edit icon.
  2. Make the desired changes then click Submit.

You can also View and Remove the Administer Subjects page.

Suggest edit
Last updated on August 4, 2018

6.Schedule Events

Before you can enter data for a scheduled event, 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 Schedule Study Event pop-up.  The following event types are available:

  • 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 or an unscheduled additional visit.
  • eSource Study Event: When data is directly collected or imported in Captivate, or if the event start date must be automatically collected during initial data entry.  This event type is available only if the eSource study feature is enabled in the Study Parameter Configuration, under Build Study.
  • Common Study Event: When CRFs are used for more than one different Event, such as a Concomitant Medications Log.

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 Events not yet scheduled, click Start Data Entry. In this case, the event will be automatically scheduled and the event start date/time will be set to the current date and time.

To dismiss the pop-up without making any changes, click Cancel.

Note: Common and Unscheduled events, and those events for which start date/time will not be collected, do not need to be scheduled.

Suggest edit
Last updated on August 4, 2018

6.1.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.

Calendar Icon in Subject Matrix
2016-04-03_15-55-11

Click the Calendar icon to open a pop-up window with the scheduling details for the Calendared Events. All column headers are sortable.

Sample Calendared Events Parameters details
2016-04-03_15-57-12

A Calendared Event must be completed within a minimum and maximum date range. In the above image, the 6-Month Visit is scheduled for 18-Apr-2016, and must be completed no sooner than 08-Apr-2016 and no later than 28-Apr-2016. If a Calendared Event is not completed within the expected timeline:

  • An automatic query is generated by the system.
    2016-04-03_16-07-38
  • The Calendar icon on the Subject Matrix turns red.
    2016-04-03_16-09-44

A reminder email can be sent before the Calendared Event occurs. The study user(s) who receive the reminder email is determined by the event definition and can include the data entry person, the facility contact, and/or any other specified study user(s). The date on which the reminder email will be sent in relation to the last reference event is determined by the event definition.

When all the Calendared Events are completed and the queries, if any, closed, the Calendar icon is no longer displayed in the Subject Matrix.

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.

Suggest edit
Last updated on May 25, 2018

6.2.Event Status

There are different ways to view the Study Events status:

  • Use View All Events to see all Events that match the criteria that you specify, see View 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
2016-03-20_12-03-38 Not Started 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.
2016-03-20_12-04-30 Scheduled After a Subject has been scheduled for an Event. This is automatically set.
2016-03-20_12-06-13 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.

2016-03-20_12-07-10 Stopped When a Subject has temporarily stopped participating in a Study.
2016-03-20_12-07-58 Skipped When a Subject does not complete an Event.
2016-03-20_12-08-44 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.

2016-03-20_12-09-26 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.
2016-03-20_12-10-13 Coded The item has been coded.
2016-03-20_12-14-34 Not Coded The item has not been coded.
2016-03-20_12-15-25 Source Data Validated (SDV) After all the completed CRFs with full or partial SDV requirements have been validated. This is automatically set.
2016-03-20_12-16-03 Signed When all the CRFs for an Event have a status of Completed or Not Started. When you sign the casebook for a Subject, Captivate 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.
2016-03-20_12-16-50 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.

2016-03-20_12-17-31 Removed When an event has been removed.
Suggest edit
Last updated on August 4, 2018

6.3.Edit Event

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.
    2016-04-03_19-13-11
    The Update Study Event page opens.
    2016-04-03_19-12-44
  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.

2016-04-03_19-15-53

Suggest edit
Last updated on August 4, 2018

6.4.View Event

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.

View Event icon in Event Details pop-up
2016-04-03_14-27-08

Suggest edit
Last updated on August 4, 2018

6.5.View Events

The View All Events page contains information for each Event Definition that matches 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.
    2016-04-03_16-14-18
  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-Apr-2016 and 30-Apr-2016.
  3. Click Apply Filter. Captivate 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.
    2016-04-03_16-17-05

The Event name is shown about each table. The Subject ID, Event date, and Subject Event status (Scheduled, Completed, and Discontinued) are shown inside each table.

By default, Subjects 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. Captivate 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 by clicking the View icon 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.

Note:

  • Study Sponsor, Study Monitor and Site Monitor user roles can only view and query events.

 

Suggest edit
Last updated on August 4, 2018

7.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 data, 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.

Notes:

  • Study Sponsor, Study Monitor and Site Monitor can only view and query information on the subject Matrix. They cannot make changes to clinical data.
  • Study Coder and Study Evaluator do not have access to the Subject Matrix.
Suggest edit
Last updated on August 1, 2018

7.1.Subject Matrix Pop-up

If you place your cursor over an Event status icon, a pop-up appears. 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 Schedule Pop-Up appears:

Scheduling an Event using the pop-up

2016-04-03_13-41-48

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.

After an event is scheduled, if you position your pointer over the status icon, a Scheduled Event pop-up appears.

Sample Schedule Study Event pop-up

2016-04-03_13-44-42

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 the CRF is required, i.e., data must be submitted on the CRF.

The green check mark (2016-03-20_14-49-51) indicates that a full or partial SDV must be performed after data collection has been completed. (Only viewable by Monitor (CRA) or Admin roles.)

Note: Common and eSource events, and those events for which start date/time will automatically collected when data is initially entered. They do not need to be scheduled.

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.

View Event page

2016-04-03_13-43-09

Suggest edit
Last updated on May 25, 2018

7.2.Subject Matrix Pop-up Action Icons

In the Subject Matrix pop-up, click the action icon to work with 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
 2016-03-20_12-24-49 Edit Edit or modify an object such as a Subject or an Event.
 2016-03-20_15-01-57 Enter Data Allows users to enter data into a CRF.
 2016-03-20_12-23-21 View Displays information on an object such as a Subject, an Event, a Site or a CRF.
2016-03-20_15-02-32 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.
 2016-03-20_15-09-25 Sign Allows an Investigator to sign the entire Subject’s casebook or an Event.
 2016-03-20_12-26-16 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.

Note:

  • Remove/Restore actions are allowed only for these user roles:
    • System/Study Administrator
    • Investigator
 2016-03-20_12-29-04 Restore Restores an object that was previously removed. Restore brings back the object into the Study or the Site without data loss.
 2016-03-20_15-10-11 Delete Allows a Study Administrator to permanently delete an object, such as a CRF.
 2016-03-20_15-11-03 Reassign Study Subject Allows a Study Administrator to reassign a Study Subject to a different Site in the Study.
 2016-03-20_12-29-39 Print Print an object such as a CRF or a Note & Discrepancy.
Suggest edit
Last updated on August 1, 2018

7.3.Locking and 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
2016-03-20_12-27-11 Lock Lock a Subject casebook.
2016-03-20_12-28-11 Unlock Unlock a Subject casebook.

Lock/Unlock Subject icons in Subject Matrix

2016-04-03_13-58-28

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.

Suggest edit
Last updated on August 4, 2018

7.4.Dynamic Groups

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 the image below, the Dynamic Group names are Screening, Radio Therapy, and Surgery.
  • A default Dynamic Group can also be automatically assigned to a new Subject. In the image below, 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 the image below, subject 003, 004, 006 and 007 have not been assigned to a Dynamic Group yet.
  • 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.

Dynamic Groups in a Subject Matrix

2016-04-03_13-58-28

 

Suggest edit
Last updated on May 25, 2018

7.5.Submitting Data for a Subject

You can submit data for a Subject only 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.

Suggest edit
Last updated on May 25, 2018

7.6.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, or other Group information as configured for the study.

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.

Show More Subject Information

2016-04-03_14-06-45

Suggest edit
Last updated on May 25, 2018

7.7.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: 1, 5, 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, on the previous screenshot, 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 CRF status matches the criteria you specify. You can specify the criteria for one Event column, and any of the other columns.

  • 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.

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).
Subject Matrix filtered by Subject ID
2016-04-03_14-17-44
Subject Matrix with multiple filters
2016-04-03_14-20-29

Suggest edit
Last updated on May 25, 2018

7.8.Study 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.

Edit Subject and View Subject icons in Event Details pop-up
2016-04-03_14-27-08

The View Subject page contains all study information for the selected Subject in the following sections: Study Subject Record, Subject Casebook, and Events.

View Subject Record page
2016-04-03_14-32-50

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.

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.

Study Subject Record section
2016-04-03_14-39-32

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.

Update Study Subject Details page
2016-04-03_14-42-00

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.

Subject Casebook section
2016-04-03_14-43-01

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.

Events Section

The Events section shows information about all the events currently in progress for a Study Subject.

Events section
2016-04-03_14-44-51

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; the status will return to its previous status.

For more details about editing a CRF, see Entering CRF Data.

By default, Events are ordered by event order. Click a column header to order the Events by that column. Click again in that column to reverse the sorting order.

Suggest edit
Last updated on May 25, 2018

8.Entering CRF Data

Captivate provides the following options to enter data in a CRF:

  • Manual Data Entry: Manual data entry using web-based interface, see Manual Data Entry. Captivate 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 Captivate 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 Captivate Programmer’s Guide for details.
Suggest edit
Last updated on May 25, 2018

8.1.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.

      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
      • 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 (2016-03-20_14-49-51) indicates that a full or partial SDV must be performed after data collection has been completed.

  2. If multiple versions of the CRF are available, 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 that will open when entering the CRF is the one called “Informed Consent”.


    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, in the example above, for the second page, click on “Demographics”.
    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.
  5. Enter the information for the current Page. The Exit button now changes to a red button marked Cancel, indicating that the page now contains unsaved data. You can use the tab key to quickly move between fields.
    Note: Within tables, the order in which the fields are accessed by tabbing (Left to Right or Top to Bottom) is determined by the CRF definition.
  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 may be 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 (2016-03-21_10-38-02) icon for the item and entering the note. For details, see Notes and Discrepancies.
  7. After completing a CRF Page:
    1. 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.
    2. If you want to save the data you have entered so far and return to the CRF later, check the Partial Data box, then click Save. Validations (including edit checks) will not be run.
    3. If you want to keep the information you entered for that Page and run edit checks, click Save.
    4. If you want to keep the information you entered for that Page and go to the next CRF in the event, click Save & Next.
    5. If there are problems with the data that you entered, Captivate does not save the data and displays messages concerning the information that is incorrect.
    6. Captivate 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 or a Query. 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.

    7. Upon saving a Page, Captivate performs any necessary calculations specific for that Page, and displays the next Page in the CRF, if any.
  8. Complete and save all Pages in the CRF.
  9. In the last CRF Page:
    1. 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.
    2. After all information has been entered in the CRF, select the Mark CRF Complete checkbox, and click OK in the confirmation dialog box.
    3. Click Save in the last Page.
      1. If a password is required, supply your password in the dialog box that opens.
      2. If double data entry is required for the CRF, the CRF must be re-entered by another user.
      3. If CRF evaluation is required for the CRF, the study evaluator will be able to evaluate the data, and change it if necessary.
    4. The Subject Matrix opens, and the Status for the CRF will be:
      1. Initial Data Entry Complete – If the next step is double data entry or CRF evaluation and the CRF has been marked Complete.
      2. Data Entry Complete – If the data is ready to be submitted to the Monitor or Investigator and the CRF has been marked Complete.
      3. 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.

Suggest edit
Last updated on May 25, 2018

8.2.Partial Data Entry

New in v2.2 is the ability to mark a CRF page Partial Data Entry.

Partial Data Entry allows the user to quickly leave the CRF page and come back to it later, without having to make sure all the page validations or edit checks are fully resolved.  The data entry user can now check the box for Partial entry, at either the top or the bottom of the CRF page:
partial-data-entry

When this CRF page is checked and saved, a new icon will appear in the Subject Matrix, as a visual cue that the CRF is only partially entered:
pde-subject-matrix

Only when the user enters the CRF another time, will they be able to save the rest of the data and unmark the CRF for Partial data entry.

Suggest edit
Last updated on May 25, 2018

8.3.Subject Randomization

Captivate 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 Captivate and randomize.net is encrypted.

Captivate can also support 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.
    2016-03-18_16-01-20
  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.
    2016-03-18_16-02-13
  6. If the randomization result matches the name of a Dynamic Group for the study, 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 and a kit ID.

  • 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.
  • The system will determine whether the subject is receiving the product or placebo and will display the first corresponding kit ID.

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.

Subject Randomization CRF
Subject Randomization CRF

Suggest edit
Last updated on May 25, 2018

8.4.CRF Unavailable

Captivate 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, Captivate 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.

Suggest edit
Last updated on May 25, 2018

8.5.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 Captivate. 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, Captivate 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:

  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.
Suggest edit
Last updated on May 25, 2018

8.6.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 2016-03-20_12-03-38 The CRF has not been opened for data entry.
Partial Data Entry The CRF has been opened for data entry. The user has entered some data into the CRF and has checked the Partial Save box and clicked Save.
Initial Data Entry 2016-03-20_12-06-13 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 2016-03-20_12-08-44 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 2016-03-20_12-09-26 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.
Partial Double Data Entry A user has opened the CRF for Double Data Entry, entered some data, checked the Partial Save box and clicked Save.
Double Data Entry Started 2016-03-21_17-40-30 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 Evaluation Complete 2016-03-20_12-08-44 When the CRF has been marked complete after Double Data Entry or CRF Evaluation.
Locked 2016-03-20_12-16-50 Captivate 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.
Suggest edit
Last updated on May 25, 2018

8.7.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 Captivate 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 pre-configured some reasons for changing the data. Contact your Study Administrator if additional reason changes are required.

Suggest edit
Last updated on May 25, 2018

8.8.Data Entry Timeout

If you are interrupted while entering data on a CRF, and your session times out while you are away from your computer, upon your return, you have the option to resume data entry or to delete the data and exit the CRF.

If you click Resume Data Entry, the system prompts you to re-enter your password.

2016-04-23_18-42-54

When you click Login, no CRF data is lost and your session resumes. You can continue the data entry.

If you click Delete Data & Exit, the CRF data you previously entered will be deleted and you will be re-directed to the main Login page.

Suggest edit
Last updated on May 25, 2018

9.Import Data

As an alternative to performing manual data entry, you can import Event CRF data from a file using the Captivate web interface. This import feature is useful when your Study data was captured using a system other than Captivate.

The following items are required to import data:

  • The Study exists
  • 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, unless the study parameters are modified to generate Study Subjects automatically
  • Study Subjects must be scheduled for the Study Events for which the data is being imported, unless the study parameters are modified to auto-schedule Events for Study Subjects

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, unless the study parameters for Auto-Completion are turned off. 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 using SOAP Web Services. Refer to the Captivate Programmer’s Guide for details.

Suggest edit
Last updated on May 25, 2018

9.1.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:

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 import? Select Yes to automatically schedule events during import, or 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 import? Select Yes to replace existing data during import, or select No if existing data should be skipped during import.
Suggest edit
Last updated on May 25, 2018

9.2.Data File Import

Users with proper permissions can import data from an XML file using the Captivate 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.
    Captivate 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, Captivate 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.
    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. Captivate 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 or if you set the Rule to run on Import in the rules designer in Captivate Build. 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.

Suggest edit
Last updated on July 30, 2018

9.3.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 Captivate 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 Captivate Programmer’s Guide.

Suggest edit
Last updated on May 25, 2018

9.4.Data File Validation

When you import a data file, Captivate 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.

Captivate 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 Captivate session where you want to import the data. Note that you can only import for those Study Subjects in a given Site, so you may have to generate one file per Site for the Import.
  • 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.
  • 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, Captivate 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.
Suggest edit
Last updated on May 25, 2018

10.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 and annotations, 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 Captivate Build User’s 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.

Captivate 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.

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.

Notes:

  • Queries can only be created and closed by the Study Monitor, Site Monitor and Study Coder user roles.
  • The Study Coder user role can only access and close the queries they created.
  • If the CRF masking is enforced for your user role, you cannot work with notes or discrepancies for CRFs that have been masked from you.
Suggest edit
Last updated on August 1, 2018

10.1.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. Captivate 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. Captivate 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 Captivate detects that the failed validation is intentional. Thus, it will create a Failed Validation Check Parent Note and the data entry 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. Captivate 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.

Captivate 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. Captivate 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.

Suggest edit
Last updated on May 25, 2018

10.2.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.

The following table shows the different Discrepancy Note Status values:

Icon Status Description
2016-03-21_18-47-10 New This is the initial status for a Query or Failed Validation Check Note type.
2016-03-21_18-47-38 Updated Used when responding to a Note.
2016-03-21_18-47-59 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.
2016-03-21_18-48-18 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
Suggest edit
Last updated on May 25, 2018

10.3.Creating Discrepancy Notes

Discrepancy Notes can be created automatically by Captivate, or manually by users.

Automatically-Created Discrepancy Notes

Captivate 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, Captivate 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, Captivate prompts you to provide a valid value. If you do not correct the data after being prompted and click Save again, Captivate saves the CRF and automatically creates a Discrepancy Note. For details, see Manual Data Entry.
  • When you import data, if errors are found Captivate automatically generates a Failed Validation Check.
    Note: In some cases, Captivate 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 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.
  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: Captivate 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 (2016-03-21_18-48-18) if the note entered was an Annotation.
  • The flag icon color is red (2016-03-21_18-47-10) if the note entered was a Query.

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. Captivate 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.
Suggest edit
Last updated on May 25, 2018

10.4.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:

  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. Captivate 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. Captivate displays the details of the Discrepancy Note in the Notes and Discrepancies 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.

Suggest edit
Last updated on May 25, 2018

10.5.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.

  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.
  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 (2016-03-20_12-26-16) icon.
  4. In the CRF and in the Notes and Discrepancies page, the color of the flag icon for that note changes to yellow (2016-03-21_18-47-38) 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). Captivate will automatically process the query Update as a Reason For Change.

2016-03-18_16-18-01

Suggest edit
Last updated on May 25, 2018

10.6.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.

Notes and Discrepancies page

A quick way to access only the Notes and Discrepancies assigned to you is from the Captivate 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 26 shows an example of the details table, filtered to show only the three items with a New status, after clicking the number 3 in the summary table.

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.
  • 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
  • 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
2016-03-20_12-29-39 Print Print the selected item.
2016-03-20_12-23-21 View Displays information on the item.
2016-03-20_13-06-37 View within Record Opens the Note and its associated location (CRF, event. Subject, etc.).
2016-03-20_13-01-40 Download Notes Download notes.
Suggest edit
Last updated on May 25, 2018

10.7.Finding and Organizing Discrepancy Notes

Captivate 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.

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).

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.

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.

Suggest edit
Last updated on May 25, 2018

10.8.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 (2016-03-24_13-09-21).
    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.
Suggest edit
Last updated on May 25, 2018

10.9.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.
  2. Select one or more discrepancies for which to generate DCFs by checking the corresponding box(es) in the DCF column.
  3. Alternatively, click the Generate DCF icon in the Actions column.
  4. Click Generate DCF.
  5. 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.
  6. 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:
    • 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.
Suggest edit
Last updated on May 25, 2018

11.Source Data Verification

ClinCapture offers risk-based Source Data Verification (SDV) to help you review your CRF data for conformity and track evaluations, to ensure your Study is complete, accurate, and verifiable based on risks.  You can select from one of the following levels to perform SDV based on risks.

  • Don’t perform source data verification
  • Source data verify the entire CRF
  • Source data verify specific items in the CRF.

These options can be set at the study or site level.  That is, some sites may be required to source data verify the entire CRF, while others are required to source data verify specific CRF items, and other may be exempt from source data verification.

When using SDV, Captivate presents only the CRFs  that 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.

Notes:

  1. 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.
  2.  If the CRF contains PHI data, they will be masked to the Study Monitor.  PHI data must be SVD-ed by the Site Monitor.
Suggest edit
Last updated on May 25, 2018

11.1.Verifying Source Data

Study Monitor and Site Monitor users can verify source data. 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.
  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 (2016-03-20_12-15-25). 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.
    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. 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.
  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.

Suggest edit
Last updated on May 25, 2018

11.2.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.

Suggest edit
Last updated on May 25, 2018

11.3.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.

Suggest edit
Last updated on May 25, 2018

11.4.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.

Suggest edit
Last updated on May 25, 2018

11.5.Resetting SDV Status

Source Data Verification status can be reset from verified to unverified either manually by a user with appropriate permissions, or automatically. Unverified CRFs can be verified again later on. The Study Audit Log tracks any change in Source Data Verification status for a CRF.

  • Automatically: Captivate 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.
Suggest edit
Last updated on May 25, 2018

12.Electronic Signatures

If your user role has appropriate permissions, you can sign a Study Event or an entire casebook for a Subject. The Captivate electronic signature process complies with the FDA Code of Federal Regulations (CFR) Title 21 Part 11.

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.
    2016-04-03_19-24-07
    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, using the View icon next to each CRF.
    2016-04-03_19-30-11
  3. Enter your username and password in the appropriate fields.
  4. Click Sign.
    The View Subject page opens and shows the Status of the Event as 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.
    2016-04-03_19-33-59
  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.

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.

Suggest edit
Last updated on May 25, 2018

13.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 Captivate Modules.

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.

View Study Log page

Suggest edit
Last updated on May 25, 2018

13.1.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.

Audit Logs page for a Subject

Suggest edit
Last updated on May 25, 2018

13.2.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
  • 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
CRF deletion
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 non-existent 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.

Suggest edit
Last updated on May 25, 2018

13.3.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).

Example Subject Study Audit Logs export

Suggest edit
Last updated on May 25, 2018

14.Email Log

New in v2.2, Administrators can use the Email Log to track when emails were sent out to other users, notifying them of different actions in the system.  These actions can include:

  • changing a password
  • running a casebook or extract
  • firing of an email rule
  • completion of a certain CRF
  • reminder for Calendared Events

From the Email Log page, the Administrator can see when an email was sent out and to whom, and can even resend the email, if it did not get sent correctly or was ignored by the receiving user.

 

To inspect the Email Log, a user must be a Study Administrator or hold the ‘administrator’ user type.  You can click on the spyglass icon to see more details about the message, and can resend the message if necessary.

Suggest edit
Last updated on May 25, 2018

15.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.

Captivate supports five medical dictionaries: MedDRA, WHODrug, ICD-9-CM, ICD-10, and CTCAE. Captivate also allows using multiple versions of the same dictionary in a CRF.

Captivate retrieves medical codes from the Bioportal repository, except for WHODrug, which is supplied to Captivate through a partnership with UMC.

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.

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 (2016-03-20_12-15-25 or 2016-03-20_12-08-44) 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 (2016-03-20_12-41-02).

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.

Suggest edit
Last updated on May 25, 2018

15.1.Coding a Medical Term

Medical coding can be performed for CRFs in the following states:

  • Data Entry Started (2016-03-20_12-06-13)
  • Initial Data Entry Completed (2016-03-20_12-09-26)
  • Completed (2016-03-20_12-08-44)
  • Signed (2016-03-20_12-16-03)—Coding a Signed CRF, causes it to lose its Signed status.

Medical Coding cannot be performed for:

  • Locked CRF (2016-03-20_12-16-50)
  • 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 (2016-03-20_12-14-34) 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.
    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.
Suggest edit
Last updated on May 25, 2018

15.2.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.
Suggest edit
Last updated on May 25, 2018

15.3.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 Captivate. 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: Captivate Captivate 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 (2016-03-20_15-10-11). This allows you to delete the Code and/or Alias, and reset the medical term to a Not Coded status.
Suggest edit
Last updated on May 25, 2018

16.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.

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.

Suggest edit
Last updated on May 25, 2018

16.1.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.

Suggest edit
Last updated on May 25, 2018

16.2.Performing CRF Evaluation

To evaluate CRF:

  1. Select Tasks > Evaluate CRF to open the CRF Evaluation page.
    2016-03-18_16-44-34
  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.
    2016-03-18_16-45-50
  3. CRFs with a yellow checkmark are ready for evaluation.
    2016-03-18_16-46-34
  4. Click the Begin CRF Evaluation 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.
  • If any change was made to a data point on the CRF, a discrepancy automatically is logged.
Suggest edit
Last updated on May 25, 2018

17.Extract Data

The 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.

Suggest edit
Last updated on May 25, 2018

17.1.Datasets

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.

Suggest edit
Last updated on May 25, 2018

17.1.1.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.
  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.
    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:
    1. Click Save and Add More Items.
    2. 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.
  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.

A dataset definition has now been established and you can now generate and download a file containing all data that meets the specified criteria.

Suggest edit
Last updated on May 25, 2018

17.1.2.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.

2016-03-18_17-34-53

A page appears that indicates your dataset is being extracted. Captivate 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.

Suggest edit
Last updated on May 25, 2018

17.1.3.Viewing and Managing Dataset Definitions

You can search, edit, download and view dataset definitions for the current Study or Site.

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.
  • Click the Export icon (2016-03-24_18-28-13) to access the previously generated dataset files for the dataset definition, or generate and download the dataset to a file.
  • Click the Remove icon (2016-03-24_18-28-35) to make the dataset unavailable to other Captivate users. The Remove icon may not be available if you are an Investigator and not the original creator of this dataset.
  • Click the Restore icon (2016-03-24_18-28-54) to make a dataset available after it was previously removed. The Restore icon may not be available if you are an Investigator and not the original creator of this dataset.
Suggest edit
Last updated on May 25, 2018

17.1.4.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.
  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.
    2016-03-18_17-39-22
    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.
  3. Click the Download icon (2016-03-25_07-30-09) in the Actions column.
    Captivate 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.

Captivate 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 and generate the dataset file again, see Editing Dataset Definitions. The data in the dataset file reflects the Captivate 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.

 

Suggest edit
Last updated on May 25, 2018

17.1.5.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.

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.2016-03-18_17-41-35The 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:
    1. 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.
    2. 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.
  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.
Suggest edit
Last updated on May 25, 2018

17.1.6.Dataset File Formats

This section provides information about the dataset file formats you can generate and download.

Captivate’s standard tabular (non-CDISC XML) data export formats are HTML, Excel, tab-delimited, SPSS, SAS transport, and Comma Separated Values (.csv). The HTML, tab-delimited, Excel, and SAS transport 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

Suggest edit
Last updated on May 25, 2018

17.1.6.1.Header Table Format

The header table includes the following information:

  • Dataset name
  • Dataset description
  • Study name
  • 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.

Suggest edit
Last updated on May 25, 2018

17.1.6.2.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

Suggest edit
Last updated on May 25, 2018

17.1.6.3.Supported Extract Formats

Captivate supports exporting data in CDISC ODM, HTML, Excel, tab-delimited text, SPSS, SAS transport, and CSV formats.

CDISC ODM Formats

When you select one of the CDISC ODM formats for the dataset, Captivate 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 Captivate 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 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 Captivate, see CDISC ODM Representation in Captivate in the Captivate Programmer’s Guide and the ODM Final Version 1.3 for Implementation at the CDISC website.

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.

Tab-delimited Text Format

When you download to the Tab-delimited Text Format, the dataset is a .tsv file.

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.

SAS Transport Format

When you download to the SAS Transport Format, the dataset is an .xpt file. This option is only available if SAS extracts have been enabled for the study.  SAS extracts also contain a file for each table in .sbat format, and it is the only way to get the complete data for text fields of greater than 200 characters.

Comma Separated Values (.csv) Format 

When you download to the Comma Separated Values Format, the dataset is an .csv file.

Suggest edit
Last updated on May 25, 2018

17.1.7.Jobs

Datasets can be imported or exported automatically, according to a pre-defined schedule.  To create or manage jobs, your user role must be System Administrator.

Suggest edit
Last updated on August 4, 2018

17.1.7.1.Import Job

To create an Import Job:

  1. From the Tasks Menu, click Jobs.
  2. The Administer All Jobs page opens.  Click Import Jobs.
  3. The Administer Import Jobs page open.  Click Create Import Job.
  4. Enter:
    • Import Job Name to name the import job.  For example: Core Lab import.
    • Import Job Description to further describe the purpose for the job.
    • Import Job Study to specify the study or site to import the data into.
    • Directory name to specify a sub folder where the file to be imported will be fetched from.  This name must be provided but the ClinCapture IT staff as it must work in conjunction with SFTP settings to upload the file.
    • Start Time to schedule the job at a specific time, for example : 00:00 (midnight).
    • Frequency to run the job at the specified interval, between 10 minutes and 24 hours.
    • Contact email is a single email, or a space separated list of emails, to be notified when the job runs.
  5. Click Submit.

To manage an Import Job:

  1. Change your scope to where the job is located (specified in Import Job Study).
  2. Click the icon for the desired action: View, Edit, Disable, Delete, for the desired job.

Notes:

  • You may not see the import job in the Administer All Jobs page if your scope is different than the scope of the job, defined in Import Job Study.  For example, your scope is at the study level, but the job imports data in a site.  To see the job, you will need to change your scope to the specified site.
  • The dataset exported is available in the Extract Data page.  To access it, click Tasks Menu -> Datasets, locate the desired Dataset then click the Export Dataset icon.
Suggest edit
Last updated on August 4, 2018

17.1.7.2.Export Job

To create an ExportJob:

  1. From the Tasks Menu, click Jobs.
  2. The Administer All Jobs page opens.  Click Export Jobs.
  3. The Administer Export Jobs page open.  Click Create Export Job.
  4. Enter:
    • Job Name to name the export job.  For example: Adverse Events Export.
    • Description to further describe the purpose for the job.
    • Please Pick a Dataset to Export to associate the export job with an existing dataset.
    • Period to Run to run the job at the specified interval, daily, weekly or monthly.
    • Start Date/Time to start the job at a specific date and time, for example.
    • File formats specifies the format for the export.
    • Contact email is a single email, or a space separated list of emails, to be notified when the job runs.
  5. Click Submit.
  6. The Administer Export Jobs page opens, containing the new export job.

To manage an Export Job, click the icon for the desired action: View, Edit, Disable, Delete.

To skip the next scheduled Export Job:

  1. From the Tasks Menu, click Jobs.
  2. The Administer All Jobs page opens.  Click Running Jobs.
  3. The Currently  Data Export Jobs page open.
  4. Click Skip Next Run to skip the next time the job is scheduled to run.
Suggest edit
Last updated on August 4, 2018

17.2.Casebooks

To generate casebooks:

  1. From Tasks Menu, click Casebooks.
  2. The Casebooks page opens.
  3. You can filter the page by Site Name, Study Subject ID, Date Created and Subject Status.
  4. Check the box next to the casebooks you want to generate.  Click All shown to select all casebooks displayed.
  5. Click Generate Casebooks.
  6. A spinning icon will be displayed while the casebooks generation is in progress.

To download or delete casebooks:

  1. From Tasks Menu, click Casebooks.
  2. The Casebooks page opens.
  3. Click Download Casebooks.
  4. Click the Download icon for the casebook you want to download, or click the Delete icon to delete it.
Suggest edit
Last updated on August 4, 2018

18.GLOSSARY

Audit Log

A system feature that maintains a historical record of key actions related to a Study Subject made in the Captivate 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

A form composed in Form Studio and published to Captivate.  The form can include, Pages, Tables, Grids, and Items. 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 Captivate. Deleted information cannot be restored, although the audit log records the deletion action. 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

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.

Enrollment

Adding a Subject to a Study. The Enrollment Date is when the Subject is added to a 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

You can schedule Export Data Jobs and Import Data Jobs to run automatically at a specified frequency.

Module

A group of related tasks, 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 tCaptivate. It may be required or optional, depending on how the Study was set up.

Randomization

Captivate 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. You can restore information that has been removed to make it available again. See also Delete.

Roles

Categories for users that determine the tasks available to them in the system.

Rules

Customized logic 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 Captivate, or designed using a drag and drop interface 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 subject enrollment or study treatment has taken place, although they do not have to be physical locations. A user can  work at the Site level, which filters the view of the Study to a specific Site.

Study

A clinical trial or clinical research project, including all the metadata and data for it.

Study Event

A subject visit 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 or patient added to a specific Study. Also referred to as a Subject, however, a Subject can exist across several Studies. We generally 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 the 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.

User

A person or account created to interact with Captivate. A user can have one or more Roles in one or more Studies or Sites.

Suggest edit
Last updated on May 25, 2018
Help Guide Powered by Documentor
Suggest Edit