1. Introduction
    1. Captivate Live
    2. Referencing ClinCapture
    3. License Information
    4. Typographical Conventions
    5. Target Audience
  2. Key Concepts
    1. Functional Overview
    2. Typical EDC Workflow
    3. User Roles
  3. Getting Started
    1. Create an Account
    2. Login and Logout
    3. Password Reset and Recovery
  4. GUI Overview
    1. Finding and Organizing Data
    2. Last Row Accessed
    3. Captivate Icons
      1. Status Icons
      2. Frequently Used Icons
      3. Other Icons
    4. Alerts and Messages
  5. Header
    1. Change Scope
  6. Left Menu
    1. Tasks
      1. Review Data
        1. Evaluate Data
          1. Finding Data to Evaluate
          2. Monitoring CRFs Evaluation
        2. Verify Source Data
        3. Perform Coding
          1. Finding Terms to Code
          2. Coding Workflow
          3. Un-coding Terms
          4. Monitoring Coding Progress
      2. Import/Export
        1. Datasets
          1. Dataset File Formats
            1. Header Table Format
            2. Variable Naming Convention
            3. Supported Extract Formats
          2. Defining Datasets
          3. Extracting Data
          4. Managing Datasets
        2. Casebooks
        3. Import Data
          1. Data Import Options
          2. Data File Import
          3. Import File Format
          4. Import File Validation
        4. Jobs
          1. Import Job
          2. Export Job
      3. Manage Study
        1. Review Audit Logs
          1. Viewing Audit Logs for a Subject
          2. Changes Tracked in the Study Audit Logs
          3. Exporting Study Audit Logs for a Subject
        2. Track Emails
        3. Administer Subjects
        4. Monitor Signature
    2. Dash
      1. Widgets
      2. Customize
    3. Queries
      1. Discrepancy Note Types
      2. Discrepancy Note Status
      3. Finding Discrepancy Notes
      4. Creating Discrepancy Notes
      5. Viewing a Discrepancy Note
      6. Updating a Discrepancy Note
      7. Managing Discrepancy Notes
      8. Generating Discrepancy Correction Forms (DCFs)
      9. Monitoring Queries and Annotations
    4. Add Subject
      1. Add a Subject to Multiple Studies
    5. Subjects
      1. Subject Matrix Header
      2. Subject Matrix Pop-up Action Icons
      3. Scheduling and Event Pop-ups
      4. Event Options
        1. CRF Status Options
      5. Show More Subject Information
      6. 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. Versioning Management
        8. Administrative Editing
        9. Data Entry Timeout
      7. Locking and Unlocking a Subject Record
      8. Dynamic Groups
      9. Study Subject Record
      10. Monitoring Subjects and Enrollments
    6. Add Event
      1. Scheduled Event
      2. Event Status
      3. Edit Event
      4. View Event Details
    7. View Events
      1. Monitoring Events
    8. Verification
      1. Finding Data to Verify
      2. Verification Workflows
      3. Form-Level Verification
      4. Item-Level Verification
      5. Mass Verification
      6. Resetting SDV Status
      7. Monitoring Verification Status
    9. Reports
    10. Sign
      1. Finding Data to Sign
      2. Sign Workflows
      3. Mass Signature
      4. Monitoring Signature Progress
    11. Open Build
    12. Help
  7. GLOSSARY

1.Introduction

This document describes the features of Captivate Live 3.1, an EDC system developed by ClinCapture. You access Captivate Live using a web browser.

Supported browsers include Microsoft Edge, Mozilla Firefox 65 or newer, Google Chrome 30 or newer and Apple Safari 6 or newer.

 

 

Yes No Suggest edit
Last updated on May 20, 2019

1.1.Captivate Live

Captivate Live focuses on conducting and managing an existing study.

** Please refer to the Captivate Build User Guide to build a new study.   **

Yes No Suggest edit
Last updated on May 17, 2019

1.2.Referencing ClinCapture

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 3.1, an EDC system developed by clinCapture.”

Yes No Suggest edit
Last updated on May 17, 2019

1.3.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.
Yes No Suggest edit
Last updated on May 17, 2019

1.4.Typographical Conventions

Sample Description
User Roles Purple font, underlined when your cursor is over it, indicates a hyperlink inside this document or on the web.
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.
Yes No Suggest edit
Last updated on May 17, 2019

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.

Yes No Suggest edit
Last updated on May 17, 2019

2.Key Concepts

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

Yes No Suggest edit
Last updated on May 20, 2019

2.1.Functional Overview

Once a study has been created and deployed, Captivate Live provides a comprehensive set of role-based features to perform EDC during clinical trials, including:

  • Adding and randomizing subjects
  • Monitoring Subject enrollment
  • Scheduling Events, also known as visits
  • Entering clinical data in Electronic Case Report Forms (eCRFs)
  • Optionally performing double data entry
  • Optionally performing data evaluation
  • Optionally performing medical coding
  • Raising and resolving queries
  • Performing Source Data Verification (SDV)
  • Applying and monitoring progress of electronic signatures
  • Creating and managing datasets
  • Importing and exporting data
  • Creating adhoc graphical reports
  • Interfacing programmatically through a web service API to other eClinical systems such as ePRO, CTMS, IWRS, and Core Labs
Yes No Suggest edit
Last updated on May 17, 2019

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 CTMS system. Also, queries management may not be enabled, Source Data Verification may not be required, etc.

Yes No Suggest edit
Last updated on May 17, 2019

2.3.User Roles

User roles in Captivate are based on the roles typically found in clinical trials and in other forms of clinical research. The user role determines the features a user can access within a particular Study or Site. The user roles supported by Captivate are:

  • Study Administrator
  • Study Coder (only visible if Study parameter, Allow medical coding, is yes)
  • Study Evaluator (only visible if System or Study parameter, Allow CRF evaluation, is yes)
  • Study Monitor (CRA)
  • Study Sponsor

 

  • Investigator (PI)
  • Site Monitor
  • Clinical Research Coordinator (CRC)

The user roles available at the Study-level are different from the roles available at the Site-level. A user can have a different role in the Study or Site in which they are assigned, as long as the new role remains at the same level (Study or Site) as the initial role.

 

Yes No Suggest edit
Last updated on May 20, 2019

3.Getting Started

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

Yes No Suggest edit
Last updated on May 17, 2019

3.1.Create an Account

Create an account in Captivate

  1. Point a supported browser to: http://portal.clincapture.com
  2. From the login page below, click Create an account.
  3. Complete the following form.
Field Description
First Name *  Type your first name.
Last Name * Type your last name.
Work Email * Type a valid corporate email address. Personal emails are not accepted.
  1. Read the ClinCapture terms of service and privacy policies. They can be printed if needed.
  2. Check the box I agree to the clinCapture terms of service and privacy policy.
  3. Click Create an account.

Note: 

  • You may also receive an invitation via email granting you access to a study.  In this case, follow the procedure below to activate your account

Activate your account

  1. Check your email inbox. You will receive a registration confirmation email from ClinCapture.  This email contains a link to activate your account.
  2. Click the Activate Account link in your registration email.
  3. Complete your profile. Required fields are marked with a red asterisk.
Login Information
Username * Captivate Build will suggest a unique username.  It can be changed, if necessary.
Password * Enter a password with at least 8 characters.
Re-enter Password * Re-enter the same password.
Personal Information
First Name * This field is populated from your registration form. It can be changed, if necessary.
 Last Name *  This field is populated from your registration form. It can be changed, if necessary.
 Primary Email *  This field is populated from your registration form. It cannot be changed.
 Job Title *  Enter your job title.
Business Information
 Company *  Your company name.
International Phone Number *  Enter a telephone number where you can be reached directly. The following character types are allowed: Numbers, Space, Parentheses ( ), and Dash -.  Phone extensions are not supported.  A valid phone number is required to verify your account. We will send you a PIN code, either via SMS or voice message, to validate the phone number.
Address Line 1 Your business address.
Address Line 2 A second line is provided for your business address, if necessary.
City The city in which your business is located.
State / Province / Region The state/province/region in which your business is located.
ZIP / Postal Code The ZIP or postal code for your business.
Country The country in which your business is located.
Time Zone Select your time zone.
  1. Click Submit.
  2. Your account is activated upon a successful save.

Update an existing profile

  1. Point a supported browser to: http://portal.clincapture.com
  2. Once logged in, on the right side of the Header, click the > icon next to your email.
  3. Click User Profile.  The user profile page opens.
  4. Make the necessary changes.
  5. Click Submit to confirm and save the form.
 

 

Yes No Suggest edit
Last updated on May 17, 2019

3.2.Login and Logout

You will need valid credentials to login.

Log in to Captivate

  1. Point your browser to https://portal.clincapture.com
  2. From the login screen, type your email and password.
  3. Click Log in.

Log out of Captivate Build

  1. Hover over your username in the header and select Logout.
Yes No Suggest edit
Last updated on April 1, 2019

3.3.Password Reset and Recovery

Reset your Password

  1. Login Captivate.
  2. Click the > icon next to your email in the Header.
  3. Click Change Password.
  4. Enter your current password, then your new password twice.
  5. Click Submit.

Recover your password

  1. Click the Need Help to login? link on the login page.
  2. Enter your email address and click Submit.
  3. An email containing a link to create a new password will be sent to you.
Yes No Suggest edit
Last updated on May 17, 2019

4.GUI Overview

Once you are successfully logged, the Landing page is displayed.

From there, you can select an existing study or create a new one.

** Please refer to the Captivate Build User Guide to build a new study.  This guide focuses on conducting and managing an existing study.  The next steps are to select a study, and optionally a user role and a site. **

Notes:

  • If you have only one user role in the study, your user role will be automatically selected.
  • Similarly, if you have access to only one site in the study, the site will be automatically selected.

Once the study, user role, and site selections are done, your dashboard in Captivate will be displayed, including the following graphical elements:

  1. Header – Allows you to select the study and optionally a site, manage your user profile and password and optionally select your user role.
  2. Left Menu – Offers role-specific menu options.  See the Left Menu section for details.
  3. Page Content – Depends on the task selected in the Left Menu.   All Captivate Live tasks are documented in the Left Menu section.
  4. Alerts and Messages – Displays error and status messages.

These elements are discussed in more details below.

Yes No Suggest edit
Last updated on May 22, 2019

4.1.Finding and Organizing Data

Many tables in Captivate Live have the following features to help you find and view data.

Number of Results per Page

The bottom left corner shows the total number of results/rows and the number of results currently in view on the page. By default, when there are more than 15 results per page you can use the blue arrows to scroll through the table pages.

The top left corner shows a page navigation panel to change the page displayed.

When there is only one page in the table, the arrows are disabled (gray).

Change the Number of Results per Page

To change the number of rows shown on a page, click the drop-down list next to the arrows and select a different value.

Show More / Hide

To improve readablity, some tables only show part of their information by hiding some columns. The information showed/hidden is defined by the Study Administrator. You can display more information by clicking the link Show More link located next to page size dropdown to show or hide the additional columns.  The additional information is table-dependent.

Sort Data by Column

By default, the Subject Matrix is sorted by the first column that contains data, in descending order. 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.

 

Filter Data by Column

You can filter the information shown in a table to show only rows that match the criteria you specify.

The Select fields allow you to select an option in a drop-down to filter your information. For example show only the SDV Status done 

The Search fields allow you to filter information according to a custom typed keyword. For instance, in the Subjects Matrix, 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.

Note:

  • When filtering is applied, the table shows only the rows that contain the data you specified. There are several ways to clear all filtering and show all data: clear the text you entered, or from a drop-down list select the blank (top) item, or click Clear Filter (located to the far right of the gray fields).

 

Yes No Suggest edit
Last updated on May 17, 2019

4.2.Last Row Accessed

As you perform actions, Captivate Live remembers the last row you accessed and highlights that row with orange borders on the top and the bottom.

Notes:

  • 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 Live.

 

Yes No Suggest edit
Last updated on May 17, 2019

4.3.Captivate Icons

Captivate Live 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.

Those icons are describe in detail here below.

Yes No Suggest edit
Last updated on May 17, 2019

4.3.1.Status Icons

The Status Icons indicate the status of a particular Study Event and its Case Report Forms (CRFs). The Study Event status is aggregated from the individual status of the CRFs attached to an event. For example, if three CRFs in an event were completed, but a fourth one just started data entry, the Event status shows the Data entry started icon.

Icon Meaning
Not started / Not Scheduled
Scheduled
Partial Data Entry
Data Entry Started
Stopped, subject stopped participating in the Study
Skipped, missed visit
Completed
Initial Data Entry Completed
Partial Double Data Entry
Double Data Entry Started
Icon Meaning
Coded
Not Coded
Source Data Validated (SDV)
Signed
Locked, prevent further data updates
Removed or Disabled, remove incorrectly added subject of visit.
 
Yes No Suggest edit
Last updated on May 17, 2019

4.3.2.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
View Click to see the details of the object associated with the icon.
Edit Click to change the descriptions associated with the object.
Disable Click to remove an object.
Lock Click to lock subject records.
Unlock Click to unlock subject records.
Restore Click to restore an object that was previously removed. (The icon appears only after an object has been removed.)
Print Click to send output to a pop-up window then use your browser print object to send this output to the printer, or click on the Print button inside some windows.
Calendar Click to show a calendar to pick the date
Download  Click to download the data
Export/Test/View in context

Annotated CRF

Upversion CRF

Reassign Subject

add  Click to add a line or a log
Delete (cannot be undone)  Click to delete the data

 

Yes No Suggest edit
Last updated on June 25, 2019

4.3.3.Other Icons

Icon Queries and annotations
  Add an annotation
 

New

New DCF

  No note available
  Closed
  Updated

 

Yes No Suggest edit
Last updated on May 17, 2019

4.4.Alerts and Messages

 

This panel displays alerts and messages when you perform actions in Captivate Live. 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.

In addition, the Study Administrator can enter a specific message to be displayed to study users when they login.  For example: Please close queries ASAP, study will be locked soon.

Note:

  • The @Test environment always displays this standard message to remind users that they are not accessing the production environment:  For Testing Purposes Only: Not to be used for treatment, quality, or safety decision making nor analysis
Yes No Suggest edit
Last updated on May 17, 2019

5.Header


The Header is the area on the top of the page. It contains:

  • Live – indicates that you are now using the Captivate Live interface as opposed to Build for Captivate Build. For more information on Captivate Build, please refer to Captivate Build User’s Guide
    @Test – prefix is used to define environments that are the test environment in opposition to the production environment. All information entered in this environment is For Testing Purposes Only: Not to be used for treatment, quality, or safety decision making nor analysis
    Study Name  The current Study name. Click on it to select another study.

  • Site Name – The current Site if one is selected.
    All Sites – is displayed when the user’ scope is at the study level. Click on it to select another site, assuming you have been granted access to multiple sites. Study level users have access to all sites by default and can change their scope to a site level to view site-specific data.
  • User Name (email)  The name and email of the user currently logged in to Captivate Live.  Click on it to perform one of the following actions:
    • Update the user profile
    • Change your password
    • Review the privacy policy
    • Logout
  • Select Role – The current user role.   Click on it to select another user role, assuming you have access to multiple roles.
  • Add Logo – To add or modify the logo, please refer to Captivate Build User’s Guide
Yes No Suggest edit
Last updated on May 17, 2019

5.1.Change Scope

Captivate Live limits the tasks and data you can access based on the current scope. The current scope is either the Study-level or Site-level.

All Sites in the site selection dropdown in the Header indicates a Study-level scope, otherwise if a specific site is selected, your scope is Site-level.  When your scope is Study-level (All Sites is selected), you have access to information from all the sites included in the Study and you can can change your scope to a particular Study  site.

To change the current scope:

  1. Click the Select Study dropdown to select another study.  You will have to select your user role again.
  2. Click the All Sites dropdown to select another site.  The site specific information will be displayed.

Note: 

  • It is important to set your scope according to the task you want to perform.
  • If only one role was assigned to your user account, the scope will be automatically selected and you will not be able to change it.

 

Yes No Suggest edit
Last updated on May 17, 2019

6.Left Menu

The Left Menu provides role-based access to Captivate Live features. Here below each feature available for each user role.

Menu Administrator
Coder
Evaluator
Monitor
Sponsor
 CRC
Investigator
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 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 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 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
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
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

Note:

  • Site Monitor and Study Monitor Roles have the same rights, but their scope is either at the site level or the whole Study.
  • The features presented here for each role can be customized in Captivate Build.
Menu Description Users
Menu allowing you to access different kinds of tasks according to your role

For more information on this menu, refer to the section Tasks)

 ⒶⒸⒺⓂⓈⓇⒾ
 Dashboard, giving the user an overview of the different data he has access to  ⒶⒸⒺⓂⓈⓇⒾ
Displays the queries and annotations ⒶⒸⒺⓂⓈⓇⒾ
 Form allowing the users to add subjects in a Study  ⒶⓇⒾ
 The Subject Matrix shows all the subjects in the Study  ⒶⓂⓈⓇⒾ
 Shortcut allowing the user to add an event to an existing Subject ID  ⒶⓇⒾ
Displays the events of the Study  ⒶⓂⓈⓇⒾ
Page to perform data verification Ⓐ Ⓜ
 External links allowing you to build reports  ⒶⒸⒺⓂⓈ
 Table showing the CRFs signed or to be signed
 Open the “Capture Build” interface  Ⓐ
 Gives access at all time to the User Guides, Terms of Service, Contact Us and FAQs ⒶⒸⒺⓂⓈⒾ

 

Yes No Suggest edit
Last updated on May 22, 2019

6.1.Tasks

Different Tasks are available depending on the role of the user. The table below lists the Captivate Live’s features in Tasks, available for each user role. If a user role is not allowed to access a particular Module or task, it is not listed in the Tasks menu.

Menu Study
Administrator
Study
Coder
Study
Evaluator
Study/Site
Monitor
Study
Sponsor
CRC Investigator
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
Review Data
Evaluate Data 2016-03-20_14-49-51 2016-03-20_14-49-51
Verify Source Data 2016-03-20_14-49-51 2016-03-20_14-49-51
Perform Coding 2016-03-20_14-49-51 2016-03-20_14-49-51
Import/Export
Datasets 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51
Casebooks 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
Import Data 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51
Jobs 2016-03-20_14-49-51
Manage Study
Review Audit Logs 2016-03-20_14-49-51 2016-03-20_14-49-51 2016-03-20_14-49-51
Track Emails 2016-03-20_14-49-51
Administer Subjects 2016-03-20_14-49-51
Monitor Signature 2016-03-20_14-49-51 2016-03-20_14-49-51

 

Yes No Suggest edit
Last updated on May 22, 2019

6.1.1.Review Data

 

Note:

  • Data marked PHI in the form designer in Captivate Build, for example a subject’s date of birth, is obfuscated when it is accessed by Study-level users.
Yes No Suggest edit
Last updated on September 19, 2018

6.1.1.1.Evaluate Data

Sometimes Case Reports Forms (CRF)  may need to be reviewed by a Study Evaluator to ensure the integrity of the captured data. It is typically done for measurement-related data points.

Unlike Double Data Entry, the data to be evaluated is not blinded. 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 Study Evaluator changes the data initially entered, the system displays a message:  The value you specify does not match the value: XYZ  from initial data entry. If the user clicks Save again, a Reason For Change (RFC)  is automatically generated.  The RFC can then be reviewed for potential adjudication by a System Administrator or Study Monitor.

Evaluate data in a CRF

  1. Access the CRF Evaluation page, as follows:
    • From the CRF Evaluation Progress widget located on the Dashboard page.
    • From Evaluate Data in the Tasks menu.
  2. CRFs marked as Ready for Evaluation are ready for evaluation.
  3. Click the Administrative Editing () icon to open the CRF.
  4. Evaluate the data points/measurements. If necessary, make changes.
  5. Check the Mark CRF Complete box.
  6. 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.
  • For any change made to a data point on the CRF, a Reason For Change is automatically logged, which can be monitored by a Study Administrator or Monitor.

Notes:

  • You cannot evaluate CRFs that have been masked from you.
  • The same user cannot complete the initial data entry and perform an evaluation. Such user will not see the Administrative Editing () icon in the CRF Evaluation table.
  • Data evaluation can be performed with or without context. Context allows the Subject ID and the Event name to be displayed.
  • Data marked PHI in the form designer in Captivate Build, for example, a subject’s date of birth is obfuscated when it is accessed by Study-level users.
Yes No Suggest edit
Last updated on May 17, 2019

6.1.1.1.1.Finding Data to Evaluate

You can use the Summary Statistics table to find CRFs in a specific status.  Simply click the number in the table to display the CRFs in the desired state.

The CRF Evaluation page can be filtered and sorted to find the data you are looking for. See Finding and Organizing Data for more information.  The following filters are supported:

Filter  Values
CRF Name
  • CRF name dropdown
CRF Status
  • CRF status dropdown
    • Initial Data Entry Completed
    • Double Data Entry Started
    • Completed
    • Source Data Verified
    • Signed
    • Disabled
    • Locked
Evaluation Status
  • Evaluation Completed
  • Ready for Evaluation
Yes No Suggest edit
Last updated on May 22, 2019

6.1.1.1.2.Monitoring CRFs Evaluation

Depending on your role, you can customize your dashboard to display the CRFs Evaluation widget. This widget allows you to quickly see, in a graphical format, how many CRFs are ready for evaluation and how many have already been evaluated, over a period of time.

The graph bar for the current month can be clicked to go directly to the CRFs Evaluation page. Depending on the status selected, the page will be filtered to show only those CRFs that are available for coding or those that have been coded.

Yes No Suggest edit
Last updated on May 17, 2019

6.1.1.2.Verify Source Data

Yes No Suggest edit
Last updated on March 12, 2019

6.1.1.3.Perform Coding

Available for roles: Study Administrator and Study Coder.

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

Captivate Live retrieves medical codes from the Bioportal repository, except for WHODrug, which is supplied through a partnership with UMC. To code with MedDRA and WHODrug, you will be required to provide evidence of a current license before you can access these ontologies.

Before proceeding, you may need to change the current Study or Site scope to the one where you want to code medical items.  See Change Scope. Access the Medical Coding page, as follows:

  • From the Coding Progress widget located on the Dashboard page.
  • From the Perform Coding in the Tasks menu, if your user role is Study Administrator, or Study Coder.

Notes:

  • The Medical Coding feature is available only to the Study Coder and Study Administrator user roles.
  • Data marked PHI in the form designer in Captivate Build, for example, a subject’s date of birth, is obfuscated when it is accessed by Study-level users.
Yes No Suggest edit
Last updated on May 22, 2019

6.1.1.3.1.Finding Terms to Code

You can use the Summary Statistics table to find medical terms in a specific status. Simply click the number in the table to display the terms in the desired state.

Note:

  • When the search on a Verbatim term yields no results, the status is Code Not Found. This is either caused by a code not found in the ontology or a communication error. It is recommended to retry coding these items if a match should be found.  Contact Support in case of repeated errors.

The Medical Coding page can be filtered and sorted to find the data you are looking for. See Finding and Organizing Data for more information.  The following filters are supported:

Filter  Values
Verbatim Item
  • Type-in a complete or partial term to be coded  (Study specific)
Dictionary
  • Ontology dropdown listing the ontologies used in the current scope
Status
  • Term status dropdown
    • Coded
    • Not coded
    • Code Not Found
    • All
Study Subject ID
  • Type-in a complete or partial Subject ID
Study Event
  • Event name dropdown (Study specific)
CRF
  • CRF name dropdown  (Study specific)

The coded items can be expanded/collapsed to show or hide the coding details by clicking on the Coded icon ().

Yes No Suggest edit
Last updated on May 22, 2019

6.1.1.3.2.Coding Workflow

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

  • Data Entry Started ()
  • Initial Data Entry Completed ()
  • Completed ()
  • Signed ()

To code a medical term:

  1. Filter the Medical Coding page to display only the terms to be coded.
  2. Click the Code icon () for the item to be coded. In this example, we are going to code the item, Neutropenia.
  3. Browse through the list of results until you identify the correct code, for example Airpiprazole.
  4. Click Code or Code & Alias.

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 verbatim items with the same name. Custom dictionaries can be shared between studies.  To auto-code a medical term:

  1. Click Auto-Code at the bottom of the page.

Notes:

  • Coding a Signed CRF, causes it to lose its Signed status and revert to Completed.
  • Medical Coding cannot be performed for a Locked CRF.
  • To correct a spelling issue with a Verbatim Term before coding it, modify the name in the Search box in the Medical Codes column.
  • Clicking Code & Alias codes the item and adds an alias (synonym) in the custom dictionary, enabling the automatic coding of similarly named verbatim items.
  • A Study Coder can open the CRF where the verbatim term is located by clicking the Open CRF icon ( or  or ) in the Actions column.
  • The medical term can be queried, if necessary. Click this icon () to raise a query to the site.
Yes No Suggest edit
Last updated on May 17, 2019

6.1.1.3.3.Un-coding Terms

Medical term status can be reset from Coded to Not Coded either manually by a user with appropriate permissions, or automatically by Captivate Live. After resetting a medical term, it can be coded again. The Subject Audit Log tracks any change in Medical Coding status for a medical term.

  • Automatically: Captivate Live automatically resets the Medical Coding status for a medical term if the verbatim item in the CRF changes.
  • Manually: To manually change the Medical Coding status for a medical term on the Medical Coding page, click the Delete icon (). This allows you to delete the Code and/or Alias, and reset the medical term to the Not Coded status.

Yes No Suggest edit
Last updated on May 17, 2019

6.1.1.3.4.Monitoring Coding Progress

Depending on your role, you can customize your dashboard to display the Coding Progress widget. This widget allows you to quickly see, in a graphical format, how many CRFs are ready to be coded and how many have already been coded, over a period of time.

The graph bar for the current month can be clicked to go directly to the Medical Coding page. Depending on the status selected, the page will be filtered to show only those CRFs that are available for coding or those that have been coded.

Yes No Suggest edit
Last updated on May 17, 2019

6.1.2.Import/Export

The Import/Export module allows users with the right permissions to target a set of data, then export it to a file to be reviewed or used in other applications.

Clinical Research Coordinators, Investigators and Study Administrators can import data from an XML ODM file.

Study Administrators can also configure jobs to regularly import and export data.

Yes No Suggest edit
Last updated on September 25, 2018

6.1.2.1.Datasets

This option is available for the roles Study Administrator, Sudy/Site Monitor, Study Sponsor and CRC.

To create a dataset, you define a set of criteria to target data in the current Site or Study.

After defining the dataset criteria, 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 definitions.

The Dataset page allows you to find and organize the datasets created for a Study.

Yes No Suggest edit
Last updated on May 17, 2019

6.1.2.1.1.Dataset File Formats

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

Captivate Live creates downloadable datasets in the following file formats:

  • CDISC ODM XML
  • View as HTML
  • Excel
  • Tab-delimited Text
  • SPSS
  • SAS transport
  • 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

Yes No Suggest edit
Last updated on May 17, 2019

6.1.2.1.1.1.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.

Yes No Suggest edit
Last updated on May 17, 2019

6.1.2.1.1.2.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

Yes No Suggest edit
Last updated on May 17, 2019

6.1.2.1.1.3.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.  Two outputs are provided:

  • Normalized – One worksheet per CRF and one column per CRF item; this is akin to a SAS transport file
  • Non-normalized – One row per subject, and all the subject data on the same row.

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 Vales (.csv) Format

When you download to the Comma Separated Values Format, the dataset is an .csv file.  Two outputs are provided:

  • Normalized – One worksheet per CRF and one column per CRF item; this is akin to a SAS transport file
  • Non-normalized – One row per subject, and all the subject data on the same row.
Yes No Suggest edit
Last updated on May 17, 2019

6.1.2.1.2.Defining Datasets

To define a dataset:

  1. Access the Datasets page from Datasets in the Tasks menu.
  2. Click the Create Dataset button. The Create Dataset: Select Items page opens.
  3. Click an Event to list its associated CRFs. For example, clicking the Screening study event reveals the CRFs attached to it.
  4. Click the checkbox for each item to be included in the dataset, or click the Select All Items checkbox.  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.
  5. If you want to add more items, click Save and Add More Items and repeat the steps above to select the Event CRF Items to be included in the dataset definition.
  6. To select metadata Attributes to be included in the dataset definition, such as Subject Attributes, Events Attributes, Group Attributes, etc., click the corresponding link in the left area.
    For example, clicking Subject Attributes opens the Create Dataset: Select Subject Attributes page.
  7. Select the checkbox for each Attribute to be included.
  8. 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.
  9. To review the Items and Attributes that have been selected, click the View Selected Items link in the left area.
  10. 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.
  11. Set a date range for the dataset definition by following the onscreen instructions. The date range that you specify is applied to 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.
  12. 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.
  13. Click Submit. A dataset definition has now been created and you can now extract and download a file containing all data that meets the specified criteria.
  14. The Extract Data page opens.  See Extracting Data for details.

Notes:

  • If some CRFs have been masked from you, they will not be displayed when you click the associated event.
  • Data marked PHI , for example a subject’s date of birth, is obfuscated when it is extracted by Study-level users.
Yes No Suggest edit
Last updated on May 22, 2019

6.1.2.1.3.Extracting Data

After you create, edit, or select a dataset definition you are ready to extract data.

Extract data

  1. Open the Dataset page and click the Export Dataset icon.
  2. The Extract Data page opens
  3. Select the file format you want to generate. For more information about the available file formats, see Dataset File Formats.
  4. Click Extract Data.
  5. A message appears indicating that your dataset is being extracted. After some time, depending on the size of the dataset and the number of concurrent extracts, you will receive an email indicating the extracted status.

Download Data

There are two ways to download the extracted data.

  1. If the extract was successful, click on the link inside the email to download the extracted data.
  2. Click the Export Dataset icon in the Dataset page for the dataset you want to download.
    1. The Extract Data page opens.
    2. In the Extracted Files table, 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.
    3. Click the Download icon for the desired file.
    4. 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.

Notes:

  • You cannot generate datasets that include CRFs that have been masked from you.
  • Data marked PHI , for example a subject’s date of birth, is obfuscated when it is extracted by Study-level users.
Yes No Suggest edit
Last updated on May 22, 2019

6.1.2.1.4.Managing Datasets

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

View Dataset

To view datasets for the current Study or Site:

  1. From the Tasks menu, click Datasets.
  2. Click the View () icon in the Actions column next to the dataset definition you want to view.

Manage Dataset

To manage dataset definition files, use the following actions in the Actions column:

  • Click the Edit icon () to change previously created dataset definitions. See Defining Datasets for details.  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.
  • Click the Disable icon () to make the dataset unavailable to other Captivate users.
  • Click the Restore icon () to make a dataset available after it was previously removed.
Yes No Suggest edit
Last updated on May 22, 2019

6.1.2.2.Casebooks

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 is generated.

Download casebooks

  1. From Tasks Menu, click Casebooks.
  2. The Casebooks page opens.
  3. Select the Casebooks to download
  4. Click the Download icon for the casebook you want to download.

Delete casebooks

  1. From Tasks Menu, click Casebooks.
  2. The Casebooks page opens.
  3. Click Delete icon to delete it.

Note:

  • Data marked PHI in the form designer in Captivate Build, for example a subject’s date of birth, is obfuscated when casebooks are generated by Study-level users.

 

Yes No Suggest edit
Last updated on April 30, 2019

6.1.2.3.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.

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.

Yes No Suggest edit
Last updated on May 20, 2019

6.1.2.3.1.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 Options:

Data Import Description
CRF Status after Import:
  • Preserve the current CRF Status (Default) – The CRF status is unchanged after data import.
  • Set CRF status using the status in the import file – The CRF status is set using the status contained in the import file.
  • Always Set CRF status to Completed – The CRF status is always set to Completed after data import.
Auto-schedule event during import?
  • Yes  – The event is automatically scheduled, if needed, during data import.
  • No (Default)

Note:

  • If the eSource add-on feature is enabled, this parameter is set to Yes and is not editable.
Auto-create subject during import?
  • Yes  – The subject is automatically created and enrolled, if needed, during data import.
  • No (Default)

Note:

  • If the eSource add-on feature is enabled, this parameter is set to Yes and is not editable.
Replace existing data during import?
  • Yes  – Existing data is replaced during data import. Per:
    •  (Default) – The entire CRF data is replaced, if existing data is configured to be replaced (see option above).
  • No (Default)
Yes No Suggest edit
Last updated on May 20, 2019

6.1.2.3.2.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 Tasks menu, click  Import Data.
    The Import Data page opens.
  2. Click Choose File 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 Submit 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.

Yes No Suggest edit
Last updated on May 22, 2019

6.1.2.3.3.Import 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.

Generate XML

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.

Yes No Suggest edit
Last updated on May 20, 2019

6.1.2.3.4.Import 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.
Yes No Suggest edit
Last updated on May 20, 2019

6.1.2.4.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.

Yes No Suggest edit
Last updated on September 10, 2018

6.1.2.4.1.Import Job

Create an Import Job

  1. From the Tasks menu, click Jobs.
  2. The Jobs page opens.  Click Import Jobs.
  3. The 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 of the job.
    • Import Job Study to specify the study or site to import the data into.
    • Directory name to specify a subfolder 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.

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 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 the Tasks menu then Datasets, locate the desired Dataset then click the Export Dataset icon.
Yes No Suggest edit
Last updated on April 22, 2019

6.1.2.4.2.Export Job

Create an Export Job

  1. From the Tasks menu, click Jobs.
  2. The Jobs page opens.  Click Export Jobs.
  3. The 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 Export Jobs page opens, containing the new export job.

Manage an Export Job

Click the icon for the desired action: View, Edit, Disable, Delete.

Skip the next scheduled Export Job

  1. From the Tasks menu, click Jobs.
  2. The Jobs page opens.  Click Running Jobs.
  3. The Currently  Executing Data Export Jobs page open.
  4. Click Skip Next Run to skip the next time the job is scheduled to run.

Note:

  • The Exported datasets can be retrieved from the Dataset page.  See Extracting Data for details.
Yes No Suggest edit
Last updated on April 1, 2019

6.1.3.Manage Study

6.1.3.1.Review Audit Logs

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 Left Menu for user permissions.

To access the Study Audit Log, click the Tasks menu then Review Audit Logs.

The Audit Logs 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. See Finding and Organizing Data for more information.

Note:

  • Data marked PHI in the form designer in Captivate Build, for example a subject’s date of birth, is obfuscated in the audit logs when reviewed by Study-level users..  Unmasked PHI data can only be viewed by a Site Monitor user.
Yes No Suggest edit
Last updated on May 22, 2019

6.1.3.1.1.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 Audit Logs page.
  • Click the View icon in the Actions column of the Subject Matrix. The View Subject Record page opens. Click the Subject’s Audit Log button for the Subject.

The Study Subject: xxx Audit Logs page opens, providing a detailed history of all Events for the selected Subject.

Yes No Suggest edit
Last updated on May 20, 2019

6.1.3.1.2.Changes Tracked in the Study Audit Logs

The table below lists the changes tracked in the 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.

Yes No Suggest edit
Last updated on May 20, 2019

6.1.3.1.3.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).

Yes No Suggest edit
Last updated on May 20, 2019

6.1.3.2.Track Emails

Starting with v2.2, Study 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.

Yes No Suggest edit
Last updated on May 20, 2019

6.1.3.3.Administer Subjects

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

Administer Subject information

  1. From the Tasks  menu, click Administer Subjects
  2. The Administer Subjects page open.

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 subjects from the Administer Subjects page.

Yes No Suggest edit
Last updated on April 1, 2019

6.1.3.4.Monitor Signature

Available at a Site level for the role Investigator.

See Monitoring Signature Progress.

Yes No Suggest edit
Last updated on March 12, 2019

6.2.Dash

The Main Body of the Dash page contains interactive dashboards for the current Study or Site, showing statistics such as 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 Queries and Annotations page to work with the unresolved discrepancies.

Yes No Suggest edit
Last updated on March 12, 2019

6.2.1.Widgets

Below is a detailed list of the widgets available to conduct and monitor a study:

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

Avalable only for role: Study Evaluator

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.

In case more than 5  events are set up, you can click the Next button to access quickly the graphs for the additional events, without leaving the Dash interface

 

 

 

 

 

 

 

 

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.

Signature Progress

Available only for the role: Investigator

Provides a graphical presentation of the number of CRFs that are available to be signed and those that have been signed. 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.

 

 

 

 

Source Data Verification Progress

Available only for the roles: Study Administrator and Study/Site Monitor

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.

 

 

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 Study Administrator Study Monitor Study Sponsor Site Monitor Study Coder Study Evaluator CRC Investigator
 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
CRFs Evaluation Progress 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
Enrollment Status Per Site 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
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
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
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
Signature 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
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
Yes No Suggest edit
Last updated on May 20, 2019

6.2.2.Customize

The information displayed on the Dashboard can be customized and each user can choose to see the widget available to their roles in the order they prefer.

To customize the Dashboard:

  1. At the top right of the page click the contextual menu and select Customize.
  2. On the right side of the screen, the Available Widgets panel opens.
    • Click the arrows at the side of the panel to Hide it 
    • Click the arrows to Show the Available Widgets panel.
  3. Once in the Customize area, you can 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 in the main body to rearrange them.
    • Click the remove button to remove a widget from the main body. Alternately, drag and drop the widget to the Available Widgets panel.
  4. 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.

Yes No Suggest edit
Last updated on May 20, 2019

6.3.Queries

The Queries and Annotations feature enables users to document, communicate, and manage the accuracy and completeness of the clinical data. In the clinical trial community, data discrepancies are typically handled using queries, whereas data point annotations are documented in notes. Whether or not Queries and Annotations 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 queries and annotations. 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 Failed Validation Check  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 query, another user, typically a Clinical Research Coordinator, reviews it and updates it to help resolve the issue. The query originator then reviews the site response and closes the query or sends it back for further clarification.

In Captivate Live, Queries and Annotations are generally known as ‘Discrepancy Notes’. The following Discrepancy Notes are supported:

  • Query – Manually issued discrepancy note created by a study-level user.
  • Failed Validation Check – Discrepancy note automatically generated by the system when data is not valid.
  • Reason For Change (RFC) – Annotation documenting the reason for changing a data item after the CRF was marked Completed
  • Annotation – Text note attached to a data point to provide any type of clarification or documentation.

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.
  • Data marked PHI in the form designer in Captivate Build, for example a subject’s date of birth, is obfuscated when a query is accessed by Study-level users.
Yes No Suggest edit
Last updated on May 20, 2019

6.3.1.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 (RFC)
  • Annotation

Failed Validation Check

A Failed Validation Check Note type is for data that does not comply with the expected values. 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 (RFC)

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.

Yes No Suggest edit
Last updated on May 20, 2019

6.3.2.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
New This is the initial status for a Query or Failed Validation Check Note type.
New(DCF) A DCF was generated for a new discrepancy.
Updated Used when responding to a Note.
Closed This is the final status for a Failed Validation Check or a Query Note. When a Note has a status of Closed, it cannot be changed in any manner. Child Notes cannot be added. Only Study-level users can mark a Discrepancy Note as Closed.
Not Applicable This Status is reserved for Reason For Change and Annotation Note types because no further action is required. The Status of Not Applicable cannot be used for Failed Validation Check and Query Note types.
Default This indicates there is no note or discrepency. You can click on it to create one.

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 / New(DCF)
  2. Updated
  3. Closed
Yes No Suggest edit
Last updated on May 20, 2019

6.3.3.Finding Discrepancy Notes

The table at the top of the Queries and Annotations page summarizes the notes and discrepancy counts. Click a value in this summary table to filter the details table at the bottom of the page to show only those items. For example, clicking the number 2 highlighted below shows all the notes in the current scope.

The Queries and Annotations page can be filtered and sorted to find the data you are looking for. See Finding and Organizing Data for more information.  The following filters are supported.

Filter  Values
Subject ID
  • Type in a complete or partial Subject ID
Type
  • Note type drop-down
    • Failed Validation Check
    • Annotation
    • Query
    • Reason For Change
    • Query and Failed Validation Check
Resolution Status
  • Note current status drop-down
    • New
    • New (DCF)
    • Updated
    • Closed
    • Not Applicable
    • Not Closed
Site ID
  • Type in a complete or partial Site ID
Days Open
  • Type in the number of days the note was opened
 Days Since Updated
  • Type in the number of days the note was updated
 Event Name
  • Event name drop-down (study specific)
 CRF 
  • CRF name drop-down (study specific)
 Entity Name
  • Type in the CRF Item associated with the CRF
 Entity Value
  • Type in the value entered in the CRF Item
Description
  • Type in the title of the Note
 Assigned User
  • User name drop-down (study specific)

 

Clicking Show More provides the following additional filters.

Filter  Values
Note ID
  • Type in the Note ID
Entity Type
  • Type in the data type associated with the CRF Item

Notes can be sorted by the following columns.

  • Note ID (shown with Show More)
  • Subject ID
  • Date Created (shown with Show More)
  • Date Updated  (shown with Show More)
  • Days Open
  • Days Since Updated
  • Event Date (shown with Show More)
  • CRF Status (shown with Show More)
  • Detailed Notes (shown with Show More)
Yes No Suggest edit
Last updated on May 22, 2019

6.3.4.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 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 Live automatically generates a Failed Validation Check. Note that in some cases, Captivate does not allow you to import data; for example, when Hard Validation Checks are triggered by invalid Date formats or required data is missing.

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.
  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.  However, Captivate does not prevent other users from updating the Note.
  6. 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.
  7. Click Submit & Close.
  8.  The CRF Shortcuts Panel is displayed, indicating a new discrepancy was created.
  9. In the CRF page, the flag icon for the Item is changed to a color that reflects the status of the Discrepancy Note. 

Notes:

  • The flag icon color is blue () if the note entered was an Annotation.
  • The flag icon color is red () 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.
  2. Captivate opens the Notes and Discrepancies window, which contains details for the item.
  3. Click Add Note.
  4. Complete the process as if adding a new Discrepancy Note.
Yes No Suggest edit
Last updated on May 22, 2019

6.3.5.Viewing a Discrepancy Note

To list Discrepancy Notes or to find a Discrepancy Note, see Finding and Organizing 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.
  3. Captivate displays a pop-up with summary information about the Discrepancy Note.
  4. Click the flag icon to display the details about the Discrepancy Note. Captivate displays the details of the Discrepancy Note in the Notes and Discrepancies window. If there are multiple Discrepancy Notes associated with the CRF Item, each Note is presented in a separate table and it has a unique Note ID.
  5. When you are finished viewing the Note details, click Close Window.

Yes No Suggest edit
Last updated on May 22, 2019

6.3.6.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 within your site.

To update a Discrepancy Note from the Queries and Annotations page:

  1. Sort and filter to select the Notes and Discrepancies of interest. See Finding and Organizing Data for details.
  2. Click the View icon () to display the Discrepancy Note, or, click the View Within Record icon () to display both the Discrepancy Note and the associated CRF.
  3. 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.
  4. Click Submit to save the updated information but keep the window open, or click Submit and Exit to save the updated information and close the window.
    The Discrepancy Note now includes the information you provided as a new Child Note in the thread.
    If you do not want to save any of the information, click the Close Window icon.
  5. In the CRF and in the Queries and Annotations page, the color of the flag icon for that note changes to yellow () to reflect the Updated status.

Notes:

  • If the note is a Query or a Failed Validation Check, and your user role is Study Monitor, Site Monitor, Study Coder, or Study Administrator, you can assign the note to any user in the Study and you can select the E-mail Assigned User checkbox to send an email alert to the assigned user.
  • If a user changes a CRF data under Administrative Editing as a result of a query, he can update the query and does not need to enter a Reason For Change (RFC).
Yes No Suggest edit
Last updated on May 22, 2019

6.3.7.Managing Discrepancy Notes

The Queries and Annotations 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.

A quick way to access only the notes assigned to you is from the Captivate Dashboard page. This page reports how many Notes and Discrepancies are assigned to you in the current Study or Site. Click the progress bar in the My Discrepancies widget to view details about notes assigned to you in the Queries and Annotations page.

You can also click the Queries icon in the Left Menu to list all the notes related to your current scope.

Queries and Annotations Actions

The following actions are available on the Notes and Discrepancies page.

Icon Name Description
Print Prints the notes currently listed.
View Displays information about the note.
View within Record Opens the Note and its associated location (CRF, event. Subject, etc.).
Generate DCF Prints, saves or email a Discrepancy Correction Form.
Yes No Suggest edit
Last updated on May 20, 2019

6.3.8.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 set to Yes.

The following roles may have access to the DCF feature:

  • Study Administrator
  • Study Monitor
  • Study Coder

Generate DCFs for New discrepancies

  1. To make selection easier, filter the Queries and Annotations page 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. and click the Generate DCF button at the bottom of the page.
  3. Alternatively, click the Generate DCF () icon in the Actions column for a specific discrepancy.
  4. The following pop-up opens.
  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 New (DCF), 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.

Generate DCFs for Updated discrepancies

  1. To make selection easier, filter the Queries and Annotations page to show only Updated discrepancies.
  2. Click the Generate DCF () icon in the Actions column and follow the process above to generate the DCF.
  3. The discrepancy status remains 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.
Yes No Suggest edit
Last updated on May 20, 2019

6.3.9.Monitoring Queries and Annotations

Depending on your role, you can customize your dashboard to display the Queries and Annotations per CRFs widget. This widget allows you to quickly see, in a graphical format, how many Notes have been created, are in progress or have been closed over a period of time.

The graph bar for the current month can be clicked to go directly to the Queries and Annotations page.

Yes No Suggest edit
Last updated on May 22, 2019

6.4.Add Subject

Available for the roles CRC and Investigator.

When you add a Subject to a Site, you create a new Study Subject record. After adding a Subject, you can edit the information in the Subject record from the Subjects page. If needed, the Study Administrator can later change the Subject’s site assignment.

Note: some of the information displayed might be different for your Study.

To add a Subject to a Study:

  1. Click the Add Subject icon in the Left Menu.
    Or
    Click on the icon Add in the Subjects page at the top of the Subject Matrix.
  2. The Add Subject page opens.
  3. 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
  4. Enter the Secondary ID. This is another unique identifier for the Subject. This field may be labeled differently or be hidden.
  5. Enter the Person ID. This is another unique identifier for the Subject. This field may be hidden.
  6. 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.
  7. Select the Gender. This field may be labeled differently or be hidden.
  8. 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.
  9. Select the Group(s) from the drop-down list, if any Subject Group Classes were defined in the Study setup.
  10. The following buttons are available at the bottom of the page:
    • Back: Subject data entered is not saved and takes you back to the previous page.
    • Submit: Saves the Subject you just created and takes you to the Subjects page
    • 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 Subject page where you can add another one.

Notes:

  • The only user roles allowed to add Subjects is the Clinical Research Coordinator (CRC) and the Investigator.
  • Before you can add a Subject, the Site must exist and the Study status must be Deployed.
Yes No Suggest edit
Last updated on May 20, 2019

6.4.1.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 Lives 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.

Yes No Suggest edit
Last updated on May 20, 2019

6.5.Subjects

To access the Subjects page, click the Subjects icon from the Left Menu.

The Subjects page displays the Events statuses for all Subjects within your current scope. You can perform any action appropriate for your role, including viewing and entering data, performing Source Data Verification (SDV), and signing CRFs.

Each row contains one Subject. The first column contains the available actions for the Subject, the second column is the Study Subject ID and the other columns are for each Event in the Study. Each cell in the matrix contains an icon that represents 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 Change Scope for details.

Notes:

  • Study Sponsor, Study Monitor and Site Monitor can only view and query information on the Subjects Page. They cannot make changes to clinical data.
  • Study Coder and Study Evaluator do not have access to the Subject Matrix.
Yes No Suggest edit
Last updated on May 22, 2019

6.5.1.Subject Matrix Header

At the top of the Subjects Matrix you have access to several options to manage the table.

From left to right, here are the different options you have:

  • All Subjects – This dropdown menu allows you to display all the subject, or you can create different lists. To do so, just filter the table with the kind of information you want to access later faster, then click on the Dropdown list and choose to Create New List.
  • All Events – This dropdown menu gives allows you to show only one type of event, to see directly all the information on this event for each Subject. For example, if we choose to see only the event Randomization, the table would look like this:
  • Subject ID – This field allows you to access directly the Subject Record for a specific Subject ID. To do so, enter the Subject ID in the field and click Enter on your keyboard. It will open the Subject Record page.
  • Add –   Allows you to Add an entry in the table. In this instance, you can add a Subject.
  • Filter –  this button when clicked shows/hides the filters in the Subject Matrix which are situated just below the table titles.
  • More Menu –  this button allows you to access More Info/Less Info (see Show More Subject Information) or Export
Yes No Suggest edit
Last updated on May 20, 2019

6.5.2.Subject Matrix Pop-up Action Icons

From the table, you can manage each Subject Event directly from the different icons in each column.

To manage the Subject, in the column Action you can click on the left of each subject on the action drop down menu icon  to open the context menu.

Depending on your role, from this menu, you can access the Subject Record, Edit the Subject, Lock it, Remove or Transfer the Subject.

In the column Actions, you also have access to the discrepancies by clicking on the Flag.

For more information on the icons, refer to the section Captivate Icons

Yes No Suggest edit
Last updated on May 20, 2019

6.5.3.Scheduling and Event Pop-ups

If you click on an Event status icon, a pop-up appears. The pop-up disappears if you click anywhere outside of it. Two types of pop-ups are available:

  • Scheduling pop-up – This pop-up is displayed if an unscheduled event is configured to collect the start or stop date.
  • Event pop-up – This pop-up is displayed once the event is scheduled, the event type is eSource or Common, or start/top dates are not collected.

Scheduling pop-up

When you click on an unscheduled event () that is configured to collect the start or stop date, the Scheduling pop-up appears. Note that the pop-up may look different in your study as the fields inside it are configurable. You can enter a location, a Start Date and Stop Date 

Note:

  • The Study Administrator needs to enable start/stop date/time collection in the Study Options. For more information on Captivate Build, please refer to the  Captivate Build User Guide.

Event pop-up

The Event pop-up is displayed if you click on a scheduled Event, an Event whose type is eSource or Common, or an Event not configured to collect start/stop dates. It 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. For example, if your role is Investigator, a Sign icon appears only if all requirements for signature have been met.

 

The Event pop-up 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.

Queries and annotations are also directly accessible from the Event 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 has precedence over Updated, which has precedence over ClosedAnnotations and Reason For Changes notes are not reported in the pop-up. For details about notes, see Discrepancies Notes Types.

 

From the View Event page, you can access at all time to the Subject Record by clicking on the magnifying glass icon next to the subject or the button at the bottom of the page. Depending on your role and the status of the CRFs, you can Edit, View, Remove, SDV, Sign, or Re-Assign a Subject.

The bottom half of the page relates to the actions available for the Study Event. Depending on your role and the status of the CRFs, various actions can be done, such as: Edit, View, Remove, SDV, or Sign an Event.

Action icons in the table CRFs in this Study Event relate to each event. Depending on your role, various actions can be taken, such as Edit, View, Enter data, Print, Disable, 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.)

 

 

Yes No Suggest edit
Last updated on May 22, 2019

6.5.4.Event Options

To access the Event Option, click on the event icon in the Event Popup:

From this context menu, several options are available to you.

  • View to view the details of the event in read mode (no changes possible)
  • Edit to edit the event
  • Skip to skip this particular event (a skipped event will lock its CRFs)
  • Stop (a stopped event will lock its CRFs)
  • Disable (a disabled event will disable its CRFs)

 

Different options are available according to the type of event.

Event type Options available
All events  View
All events  Edit
Unscheduled Event  Skip Event

 Disable CRF

 Scheduled Event  Skip Event

 Disable CRF

  Started Event  Disable CRF
  Completed Event  Stop

 Disable

 

 

Yes No Suggest edit
Last updated on May 20, 2019

6.5.4.1.CRF Status Options

From the Event pop-up you can manage the CRFs directly by clicking on the status icons. Here are the different options you have:

 

Option Description
 Edit  Brings you to the CRF to edit it
 View Brings you to the CRF but only allows you to view it, without the possibility to make changes
 SDV  Opens the Verification page with the selected CRF so the user can Source Data Verify it
 Sign Available only for Investigator role, and only when the CRF has been SDV. It opens the Sign page with the user can sign it.
 Disable Opens a form to confirm disabling of the CRF
 Delete Opens a form to confirm the deletion of the CRF
 Version Opens a page allowing the user to reassign the CRF to a New Version (when Available)

 

 

Yes No Suggest edit
Last updated on May 20, 2019

6.5.5.Show More Subject Information

To see more information about Subjects in the Subject Matrix, click in the More Menu and select More Info.

The matrix widens to add the Date Created, Subject Status, and Site ID, or other Group information as configured for the study. Note that field names may be configured differently to meet your protocol specification.

When the Subject Matrix is expanded, click in the Context Menu > Less Info to stop showing the additional columns.

Yes No Suggest edit
Last updated on May 20, 2019

6.5.6.Entering CRF Data

Captivate Live 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 Live 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 Import Data for more information.
  • Import using Web Services: Import CRF data using SOAP Web Services. Refer to the Captivate Programmer’s Guide for details.
Yes No Suggest edit
Last updated on May 22, 2019

6.5.6.1.Manual Data Entry

To manually enter data into a CRF:

  1. Open the CRF from the Subject Matrix by clicking on the Actions menu on the left of the Subject ID, and select Subject Record.
     
    Or
    Open the View Events page, then view the detail on a Subject ID’s Event, and click on the Subject ID magnifying glass icon to view the Subject Record.

    • In the View Events page, click the Enter Data icon for the desired Event.

      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 proceeding with the CRF (for more information about versioning, see Versioning Management).
  3. The first page of the CRF opens. The title of the CRF Page is listed at the top of the form. In the example below, the CRF name is “Head Pain Measurement”.


    If notes or discrepancies exist in the CRF, you’ll find the Queries shortcut just above the CRF.

    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 sample panel above, clicking 2 in the New Queries column will advance to the first new discrepancy in the CRF and highlight the associated field. Clicking 2 again will advance to the next updated discrepancy in the CRF.
  4. Enter the information for the current Page. The Exit button now changes to cancel, indicating that the page now contains unsaved data. You can use the tab key to quickly move between fields.
  5. In the tabe name, there are two numbers in parenthesis in the example above (3/4). The first number indicates the number of fields to complete in the page. The second number indicates the total number of items in the Page.
    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 () icon for the item and entering the note. For details, see Queries.
  6. Upon saving a CRF page, Captivate Live performs any necessary calculations specific for that page, and displays the next page in the CRF, if any.
    1. If you don’t want to save the information you entered, 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, click the Edit Checks slider, then click Save. Validations (including edit checks) will not be run and you can come back to complete this CRF later (see Partial Data Entry).
    3. If you want to keep the information you entered and run edit checks, click Save.
    4. If you want to keep the information you entered and go to the next CRF in the event, click Save & Next CRF.
  7. If there are problems with the data that you entered, Captivate Live does not save the data and displays messages concerning the information that is incorrect.
    1. Captivate Live 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.
    2. 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:After completing a CRF Page:
        1. 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
        2. Option 2: Annotate the discrepant data, and click Save again.
  8. Correct all data entry errors or provide Discrepancy Notes for them, and click Save.
    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, as necessary. Repeat the data entry process for each CRF page until you reach the last one:
      4. 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.
  9. 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.
    4. Partial Data Entry – If you changed the Edit Checks slider.
Yes No Suggest edit
Last updated on May 22, 2019

6.5.6.2.Partial Data Entry

Partial Data Entry allows the user to begin editing a CRF without completing it, saving the changes and come back to it later. This lets you leave quickly the form without having to make sure all the page validations or edit checks are fully resolved.

When you enter a CRF, by default, the Edit Checks are On. This ensures the form will automatically check that all mandatory fields have been filled.

To save the CRF when it is not yet completed as a Partial Data Entry, just click on the Check to put it Off. You can now Save and quit the form.

When this CRF page is checked and saved, a new icon will appear in the Event pop-up, as a visual cue that the CRF is only partially entered ():

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.  When the CRF is re-opened, the pages marked as partially entered are clearly marked.

Yes No Suggest edit
Last updated on May 20, 2019

6.5.6.3.Subject Randomization

Captivate Live is integrated with a randomization module from randomize.net. To ensure privacy and security, all communication between Captivate Live and randomize.net is encrypted.

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.

It also supports stratified randomization, which addresses the need to control and balance the influence of covariates (baseline patient characteristics). Stratified randomization balances the control and treatment groups for age or other identified covariates.

Single- and double-blinded randomization methods are also 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 Change Scope for details. Failure to set your scope properly may result in the following error.
  2. Consult your CRF Completion Guidelines to locate the randomization CRF. Open it for data entry.
  3. Enter data on the randomization CRF, including the stratification variables required to randomize the subject.
  4. Click the Randomize Subject button once. The button is greyed-out until the randomization results are displayed.
  5. When the randomization result is available, it is immediately saved to the database, along with the stratification variables, even before the CRF is saved. This is to avoid losing the randomization result because the CRF is not saved. Click OK to dismiss the alert message.
  6. If the randomization result matches the name of a Dynamic Group 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.

Notes:

  • 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 Support to undo the previous randomization before you can try again.
  • Upon successful randomization, Subjects are assigned a randomization number and optionally a kit ID.
  • If the randomization parameter, Assign Randomization Parameters to, under Study Options is set to Study Subject ID, the randomization number becomes the Subject’s Study Subject ID, replacing the existing SSID.  For example, prior to randomization, a Subject’s SSID is S01-103. After this subject is randomized, the system generates a randomization number of 1048. The Subject’s SSID is changed to 1048.

 

Yes No Suggest edit
Last updated on May 22, 2019

6.5.6.4.CRF Unavailable

Captivate Live 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 Live displays a message in the header notifying 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.

Yes No Suggest edit
Last updated on May 20, 2019

6.5.6.5.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 Live. Double Data Entry can be classified as either optional or required, depending on the specification defined and fully described in the Study Event for each CRF.

During Double Data Entry, Captivate Live 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.
Yes No Suggest edit
Last updated on May 20, 2019

6.5.6.6.CRF Status

The Status of a CRF progresses through the data entry process in the following manner.

Some CRF states, such as SDV, Signed, and Removed, are not discussed here, since they are not part of the data entry process.

CRF Status Icon Description
Not Started The CRF has not been opened for data entry.
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 Data box and clicked Save.
Initial Data Entry The CRF has been opened for data entry. The user might have entered some or all of the data into the CRF.
Data Entry Complete The CRF has been marked complete. All required data has been entered and saved, and the clinCapture edit checks have been performed. This icon appears when the CRF is not configured for Double Data Entry or CRF Evaluation.

If you make changes to a CRF in this state, the Status remains complete. If the system is set up to create a Reason For Change Discrepancy Note, you must fill it out.

Initial Data Entry Complete If the CRF is configured for Double Data Entry or CRF Evaluation, this indicates that the CRF has been marked complete after the initial data entry and is ready for Double Data Entry or CRF Evaluation.
Partial Double Data Entry A user has opened the CRF for Double Data Entry, entered some data, checked the Partial Data box and clicked Save.
Double Data Entry Started A user has opened the CRF for Double Data Entry. The Status of Double Data Entry for a CRF is shown in the Enter or Validate Data page, in the CRF’s table.
Double Data Entry or CRF Evaluation Complete When the CRF has been marked complete after Double Data Entry or CRF Evaluation.
Locked Captivate Live 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.
Yes No Suggest edit
Last updated on May 20, 2019

6.5.6.7.Versioning Management

Several versions can be made available for a CRF by the Study Administrator.

Entering Data in new Version

You can choose to enter the new data in the latest version of a form by selecting the wanted version in the Event popup.

Updating Version in a Completed Form

If you need to update one form or to do a mass update of version you can do so by:

  1. Click on Subjects in the Left Menu
  2. The Subject Matrix is displayed
  3. Click on an Event icon to open the Event popup
  4. Click on the CRF Status Action icon and select Version
  5. The page Reassign CRF to a New Version is displayed
  6. Select the Version you want to apply to your CRF (here below the version 0.2)
  7. Click Continue
  8. On the page Confirm CRF Change, you will have several options to apply the change. You can apply this change to:
    • This Event
      • Only This Subject
      • All Subjects in This Site
      • All Subjects in This Study
    • This Event Only
      • This Subject
      • All Subjects in This Site
      • All Subjects in This Study
  9. In the Item Mapping section, you can see the differences between the fields of the previous version you were using and the one you are applying. If a field has been added or deleted you will be informed.
  10. Click Submit to apply the changes
Yes No Suggest edit
Last updated on May 20, 2019

6.5.6.8.Administrative Editing

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 Rows

You cannot delete previously saved rows from a table 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 or RFC.

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.

Yes No Suggest edit
Last updated on May 20, 2019

6.5.6.9.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.

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.

Yes No Suggest edit
Last updated on May 20, 2019

6.5.7.Locking and Unlocking a Subject Record

A Study Administrator can lock or unlock the entire casebook for a Subject. The Lock icon appears at the right end of the Subject Matrix.

To lock or unlock a Subject Record:

  1. Open the Subject Record
  2. And click on Lock / Unlock
  3. Submit the form to unlock/lock the Subject

A second way to lock/unlock the Subject would be

  1. Open the Subject Record by selecting the option in the Actions Menu
  2. Then click on the Edit button () in the Actions column.
  3. Update the Status
Icon Meaning Description
Lock Lock a Subject casebook.
Unlock Unlock a Subject casebook.

Notes

  • You can lock data at the  Event, Subject, Site and Study levels.
  • If queries or annotations exist for the Subject, you can view the data in the CRF, and access and resolve the discrepancies. However, the CRF data cannot be changed.
Yes No Suggest edit
Last updated on May 20, 2019

6.5.8.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 example above, the Dynamic Group names are Enrollment, Radio Therapy, and Surgery.
  • A default Dynamic Group can also be automatically assigned when creating a new Subject. In the example above, Enrollment is the default Dynamic Group.
  • To avoid scheduling Study Events for the wrong Dynamic Group, the icons representing the Study Events state are not visible in the Subject Matrix until the Subject is assigned to a specific Dynamic Group.
  • Dynamic Groups can work in conjunction with the randomization function to automatically assign a randomized Subject to a Dynamic Group. See Subject Randomization for more details.
  • Users have the option to manually set or override Dynamic Group assignments.

 

Yes No Suggest edit
Last updated on May 22, 2019

6.5.9.Study Subject Record

There are 2 ways to view all clinical data collected so far for a Subject:

  1. Open the Context Menu in the Actions column of the Subject Matrix
  2. Click the Subject Record option
  3. The Subject Record page opens. 

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.

Depending on your user role, 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.  This button is not available to users with a Clinical Research Coordinator or Investigator role.

Study Subject Record Section

The Study Subject Record section contains general information on the Subject, including Status, Person ID, and Date of Birth.

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.

Study Administrators can also lock all data for a subject by clicking on the Lock icon.

Subject Casebook Section

Expand this section to view or extract all clinical data collected for the subject so far, noting that CRFs that have been masked from you will not be included in the Subject’s casebook.  Depending on the size of your data, it may take several minutes to generate the casebook.

To generate 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.

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.

To search for Events by name or location, enter the value you are looking for in the search box, and click the Find icon.

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 disable a CRF for a Subject, and the CRF is marked as Disabled. You can enable a CRF that has been disabled without losing data; the status will return to its previous status.

For more details about entering data in a CRF, see Entering CRF Data.

By default, events are ordered by event order, as they appear on the Subject Matrix.  Click the Event column header to order the events by that column. Click again in that column to reverse the sorting order.

Yes No Suggest edit
Last updated on May 22, 2019

6.5.10.Monitoring Subjects and Enrollments

Depending on your role, and the scope selected, you can customize your dashboard to display the several monitoring widgets. These widgets allow you to quickly see, in a graphical format the subjects related information over a period of time.

Site Enrollment allows you to quickly see, in a graphical format, for each event how many subjects the subjects are Not in Progress, Signed, Locked or Removed for each site over a period of time.

Enrollment allows you to quickly see, in a graphical format, for your current scope, how many subjects are in Progress, Signed, Locked or Removed over a period of time.

Subject Status allows you to quickly see, in a graphical format, for your current scope, how many subjects are in Progress, Signed, Locked or Removed for the current month.

The graph bars for the current month can be clicked to go directly to the Signature page. Depending on the status selected, the page will be filtered to show only those CRFs that are available for signature or those that have been signed.

Yes No Suggest edit
Last updated on May 20, 2019

6.6.Add Event

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 Live, or if the event start date must be automatically collected during initial data entry.
  • 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 on the Scheduling pop-up. To schedule the Events and return to the Subjects page, 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.
Yes No Suggest edit
Last updated on May 22, 2019

6.6.1.Scheduled Event

A Scheduled 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, Scheduled Events () are automatically scheduled on the subject Matrix.

A Scheduled Event must be completed within a minimum and maximum date range. In the above example, the 6-Month Visit is completed and the 12-Month Visit has been automatically scheduled.

To view the detailed schedule, open the Subject Record and check the event for 6 and 12 Month Visit.

The 6 Month Visit has been completed on 05-Sep-2019 and the scheduled event is planned for the 05-Mar-2020. In this example, it must be completed no sooner than 05-Mar-2020 and no later than 15-Mar-2020, in other words in at least 6 months precisely but latest in 6 months +10 days. This is a configurable time span in the Captivate Build interface (see Captivate Build User’s Guide for details). If a Scheduled Event is not completed within the expected timeline an automatic query is generated by the system and will be displayed in the Queries and Annotations.

A reminder email can be sent before the Calendared Event occurs to one of the following users:

  • Data entry person
  • Facility contact person
  • Any other 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.

Note

  • When a reference event is inside a Dynamic Group and the subject is assigned to a different Dynamic Event, follow-up calendar events will not be automatically scheduled.
Yes No Suggest edit
Last updated on May 20, 2019

6.6.2.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
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.
Scheduled After a Subject has been scheduled for an Event. This is automatically set.
Data Entry Started After a Subject is scheduled for an Event, and any CRF for that Event is opened, the Event Status is automatically set to Data Entry Started. The Data Entry Started status applies even if you did not actually enter data.

If you inadvertently open a CRF but do not save the data, you will not be able to change the Status of the CRF or Event. To change the Status, you must delete the Event CRF, or the Event for that Subject, and restore it when you are ready to enter data.

An Event stays in Data Entry Started until all required CRFs are completed.

Stopped When a Subject has temporarily stopped participating in a Study.
Skipped When a Subject does not complete an Event.
Completed After the Status of all required CRFs (and non-required CRFs, if data entry has started) for an Event are marked complete. This is automatically set.

If you make any changes to a CRF after an Event has been completed, the Status of the CRF and the Event remain completed. You might need to complete a Reason For Change Discrepancy Note, depending on your system’s configuration. You can manually set the Event status back to Data Entry Started, and then again back to Completed, as needed.

Initial Data Entry Completed If the CRFs are configured for Double Data Entry or CRF Evaluation, this indicates that the CRFs have been marked complete after the initial data entry and are ready for Double Data Entry or CRF Evaluation.
Source Data Validated (SDV) After all the completed CRFs with full or partial SDV requirements have been validated. This is automatically set.
Signed When all the CRFs for an Event have a status of Completed or Not 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.
Locked When you no longer want Users to be able to enter or change data for an Event.

Note that you can set the Status of a Study to Frozen or Locked to prevent prospective users from changing the data; however, doing so does not change the Status of any Event in the Study.

Removed / Invalid When an event has been removed or has not been found.
Yes No Suggest edit
Last updated on May 22, 2019

6.6.3.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 Subject Matrix, open the event of the Subject by clicking on it
  2. From the Event pop-up, click the Edit icon on the Event row.
  3. The Update Study Event page opens.
  4. 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.
  5. Click Submit.

 

Yes No Suggest edit
Last updated on May 20, 2019

6.6.4.View Event Details

To view the details of a Study Event from within the Subject Matrix:

  1. Bring up the Event pop-up by clicking on the icon
  2. The Event pop-up opens.
Yes No Suggest edit
Last updated on May 20, 2019

6.7.View Events

The View All Events page contains information for Study Events that matches a search criterion.

To open the View Events page:

  1. From the Left Menu, click the View Events icon.
  2. The View Events page opens.
  3. Specify the criteria for the Events that you want to view.
  4. Click Apply Filter.
  5. 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.

The Event name is shown above each table. The Subject ID, Event Date Started, and Subject Event Status are shown inside the 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 is today or is later than its schedule date.

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.
Yes No Suggest edit
Last updated on May 20, 2019

6.7.1.Monitoring Events

Depending on your role, you can customize your dashboard to display the Event Status widget and/or the Event Summary widget.

Event Status allows you to quickly see, in a graphical format, for each event how many are scheduled, not scheduled, completed, Data Entry started, Signed, Locked, Skipped, Stopped, Disabled, over a period of time.

Event Summary allows you to quickly see, in a graphical format, for how many events in total are scheduled, not scheduled, completed, Data Entry started, Signed, Locked, Skipped, Stopped, Disabled, over a period of time.

The graph bars can be clicked to go directly to the View Events page. Depending on the status selected, the page will be filtered to show only those events.

Yes No Suggest edit
Last updated on May 20, 2019

6.8.Verification

Captivate Live offers risk-based Source Data Verification (SDV) to ensure that your Study is complete, accurate, and verifiable based on risks.  You can select from one of the following verification levels to perform SDV:

  • Not Required – Source data verification is not required
  • Entire CRF – Source data verify the entire CRF
  • Specific items –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 others yet may be exempt from source data verification.

You can perform source data verification by CRF, by Event or by Subject. You can also use filters to show only the CRFs you are interested in, for example for a specific subject or event (for more information on filters see Finding and Organizing data). After you have verified the data, you can mark the CRFs as verified, either individually or as a group.

There are several ways to access the Source Data Verification page:

  • From the Source Data Verification Progress widget located on the Dashboard page.
  • From the SDV icon on the Subject Matrix, if a subject has completed one or more events.
  • From the SDV icon on the Event Pop-up on the Subject Matrix, if the event is completed.
  • From the Verification option in the Left Menu, if your user role is Study Monitor, or Site Monitor.
  • From the Verify Source Data in the Tasks menu, if your user role is Study Administrator.

Notes:

  • Only the Study Administrator, Study Monitor and Site Monitor user roles can verify source data.
  • You may need to change the current Study or Site scope to the one where you want to perform Source Data Verification.  See Change Scope.
  • Site Monitors may not be able to verify CRFs that are masked from them – masked CRFs will not display on the Source Data Verification page.
  • Source Data Verification may be allowed to be performed with or without open queries, depending on your study configuration.
  • Fields marked PHI will be obfuscated from the study-level user roles.  PHI data must be verified by the Site Monitor.
Yes No Suggest edit
Last updated on May 22, 2019

6.8.1.Finding Data to Verify

The Source Data Verification page can be filtered and sorted to find the data you are looking for. See Finding and Organizing Data for more information.  The following filters are supported:

Filter  Values
SDV Status
  • done – CRF was SDV-ed
  • not done – CRF is available to be SDV-ed
Subject ID
  • Type in a complete or partial Subject ID
Site ID
  • Site ID dropdown
Event Name
  • Event name dropdown
CRF Name / Version
  • CRF name dropdown
SDV Requirement
CRF Status
  • Completed
  • Source Data Verified
  • Signed

 

 

Yes No Suggest edit
Last updated on May 22, 2019

6.8.2.Verification Workflows

Several workflows are available for source data verification. 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.  Before proceeding, you may need to change the current Study or Site scope to the one where you want to perform Source Data Verification. See Change Scope.

This section describes the various SDV workflows available.

SDV by CRF

From the Source Data Verification page, click the SDV by 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 completion date, with the oldest at the top of the page. The CRF view also reports the level of Source Data Verification requirement for a CRF. After verifying the data, you can mark one or more CRFs as verified.

SDV by Event

Display the Subject Matrix and click on a completed Event to open the Event pop-up. Click the CRFs Status icons and select the SDV action, if present. 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: From the Subject Matrix, click on a completed Event to display the pop-up, and click the CRFs Status icons and select the SDV action, if present. The Source Data Verification page opens and displays the CRFs associated with this Subject.
  • Option 2: From the Source Data Verification page, click the SDV By Subject tab. All Subjects in the current scope (Study-Level or Site-Level) 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 SDV by Subject 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.

The following actions can be taken when verifying CRFs by Subject:

  1. Click the View icon to open the SDV by CRF tab to access the list of all CRFs eligible for SDV for that Subject.
  2. Click the SDV icon to mark all the CRFs associated with the Subject source data verified.
  3. Check multiple subjects and click SDV All Checked.

 

Yes No Suggest edit
Last updated on May 22, 2019

6.8.3.Form-Level Verification

To perform form-level Source Data Verification:

  1. From the Source Data Verification page, set the SDV Status filter to not done and SDV Requirement to Entire CRF.
  2. Click the View icon for the CRF to be verified.
  3. The CRF opens in read only mode.
  4. Verify the CRF data against the source document; it may be necessary to click the tabs on top of the CRF to advance until the last page is displayed and the SDV and SDV& Next CRF buttons are accessible.
  5. If you raised queries while verifying the data, click Next CRF to leave the current CRF unverified and fetch the next CRF.  You can also click Exit to return to the Source Data Verification page, leaving the current CRF unverified.
  6. If the CRF was successfully verified and you need to return to the Source Data Verification page, click SDV.
  7. If the CRF was successfully verified and you want to continue with the next CRF, click SDV & Next CRF to change the CRF status to SDV and fetch the next CRF to be SDV-ed.
  8. You can also change the CRF status to SDV by clicking the SDV icon on the Source Data Verification page.
  9. When the CRF is verified, the checkbox under SDV Status is replaced by an SDV Complete icon (). The Event CRF Source Data Verification Status is logged in the Subject Audit Logs, along with the date, time, and name of the user that performed the data verification.

Notes:

  • The SDV & Next CRF function fetches the next CRF to be SDV-ed in the order listed on the Source Data Verification page.  Therefore, it is recommended to filter and sort  this page to list the CRFs in the  same order as the source documents.
  • A CRF will lose its SDV status and revert to Completed,  if any data is changed once it is verified.
  • Data marked PHI, for example a subject’s date of birth, is obfuscated when it is viewed by Study-level users.  Unmasked PHI data can only be viewed a Site Monitor.

 

 

Yes No Suggest edit
Last updated on May 20, 2019

6.8.4.Item-Level Verification

To perform item-level Source Data Verification:

  1. From the Source Data Verification page, set the SDV Status filter to not done and SDV Requirement to Specific Items.
  2. Click the View icon for the CRF to be verified.
  3. The CRF opens in read-only mode.  The Items to SDV in the CRF Shortcuts panel indicates the number of items that must be verified. Item to be verified are indicated with a purple SDV icon ().
  4. To eliminate unnecessary browsing through the CRF to locate the items to be verified, simply click on the number in the Items to SDV panel.  The first item to be verified will be brought into view, if necessary, and highlighted in yellow.
  5. To verify the item, click the blue icon next to it.  The icon will turn blue () and the number of items to SDV  in the panel will be decremented by 1.
  6. Click the number link in the Items to SDV column again to jump to the next item requiring SDV.
  7. Continue viewing the CRF and marking items as verified.
  8. When all items have been source data verified, the CRF status is changed to SDV-ed and the new status is logged in the Subject Audit Logs, along with the date, time, and name of the user that performed the data verification.
  9. Click Next CRF to fetch the next CRF.  You can also click Exit to return to the Source Data Verification page, leaving the current CRF unverified.
  10. You can also change the CRF status to SDV by clicking the SDV icon on the Source Data Verification page.
  11. When the CRF is verified, the checkbox under SDV Status is replaced by an SDV Complete icon (). The Event CRF Source Data Verification Status is logged in the Subject Audit Logs, along with the date, time, and name of the user that performed the data verification.

Notes:

  • The SDV & Next CRF function fetches the next CRF to be SDV-ed in the order listed on the Source Data Verification page.  Therefore, it is recommended to filter and sort this page to list the CRFs in the same order as the source documents.
  • Unpin the CRF Shortcuts panel to keep it visible as you scroll down a long CRF.
  • If specific items must be verified, the CRF will lose its SDV status and revert to Completed, only if the data that was verified is changed.
  • Data marked PHI, for example, a subject’s date of birth, is obfuscated when it is viewed by Study-level users.  Unmasked PHI data can only be viewed by a Site Monitor.
Yes No Suggest edit
Last updated on April 30, 2019

6.8.5.Mass Verification

Some Data Management Plans may require a small percentage of the CRFs to be visually verified, up to a defined error threshold.  Captivate Live supports this requirement by allowing you to mark multiple CRF-level to be Source Data Verified, as follows:

  1. From the Source Data Verification page, set the SDV Status filter to not done.
  2. Check the CRFs to be marked source data verified without visual verification.
  3. Click SDV All Checked.  The checkboxes under SDV Status are replaced by an SDV Complete icon (). The Event CRFs Source Data Verification Status are logged in the Subject Audit Logs, along with the date, time, and name of the user that performed the data verification.

 

Yes No Suggest edit
Last updated on April 30, 2019

6.8.6.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.

  • If specific items must be verified, the CRF will lose its SDV status and revert to Completed, only if the data that was verified is changed.
  • If an entire CRF must be verified, it will lose its SDV status and revert to Completed  if any data is changed once it is verified.

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 CRF: 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: 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.

Another way for a Study Administrator to reset the SDV status for an Event is to edit it and change its status to Completed.  Note that the Event CRFs will retain their SDV status.

Yes No Suggest edit
Last updated on May 20, 2019

6.8.7.Monitoring Verification Status

Depending on your role, you can customize your dashboard to display the Source Data Verification Progress widget. This widget allows you to quickly see, in a graphical format, how many CRFs are ready to be verified and how many have already been verified over a period of time.

The graph bar for the current month can be clicked to go directly to the Source Data Verification page. Depending on the status selected, the page will be filtered to show only those CRFs that are available for SDV or those that have been SDV-ed.

 

Yes No Suggest edit
Last updated on May 20, 2019

6.9.Reports

Captivate Live lets you create ad hoc reports automatically.

All user roles have access to the creation of reports, but only the Site Administrator can access the option to Refresh Business Views.

 

Once logged in the JReport interface, you access the main Dashboard allowing you to get more information on this tool through the How To’s on the left.

To access a created report, just click on Open > Public Folder

Navigate through the folder until displaying your site(s)

Select the Site and display the report you want to see.

 

Yes No Suggest edit
Last updated on May 20, 2019

6.10.Sign

A user with the Investigator role can sign a CRF, an Event or an entire casebook for a Subject. The electronic signature process complies with the FDA Code of Federal Regulations (CFR) Title 21 Part 11.  Electronic signatures include:

  • A signature statement make it binding and equivalent to a written signature
  • User’s full name
  • Date and Time
  • User’s role

The user must then authenticate a second time to apply the signature.  A sample electronic signature is shown below.

There are several ways to access the Signature page:

  • From the Signature Progress widget located on the Dashboard page.
  • From the Sign option in the Left Menu, if your user role is Investigator.

Notes:

  • You may need to change the current site scope to the one where you need to apply an electronic signature.  See Change Scope.
  • Only the Investigator user role can sign the clinical data. Study Administrators and Monitors can monitor the signature progress.
  • Investigators cannot be masked from any data in their site.  Also, the signature cannot be applied if there are open queries. That is because the regulation requires investigators to certify that the clinical data is complete and accurate.
Yes No Suggest edit
Last updated on May 22, 2019

6.10.1.Finding Data to Sign

The Signature page can be filtered and sorted to find the data you are looking for. See Finding and Organizing Data for more information.  The following filters are supported:

Filter  Values
Sign Status
  • Signed – CRF was signed
  • Not Signed – CRF is available to be signed
Subject ID
  • Type in a complete or partial Subject ID
Event Name
  • Event name dropdown
Study Event Status
  • Event status dropdown
    • Data Entry Started
    • Completed
    • Source Data Verified
    • Signed
CRF Name / Version
  • CRF name dropdown
CRF Status 
  • CRF status dropdown
    • Completed
    • Source Data Verified
    • Signed

 

Yes No Suggest edit
Last updated on May 22, 2019

6.10.2.Sign Workflows

Several workflows are available for signing clinical data. For example, you can sign all CRFs for a particular CRF, Event or Subject.  Before proceeding, you may need to change the current Study or Site scope to the one where you want to apply your signature.  See Change Scope.

This section describes the various electronic workflows available.

Sign by CRF

There are two options for signing specific CRFs:

  • Option 1:From the Subject Matrix, click on the action icon for the desired CRF to open the Event pop-up. Select the desired and Source Data Verified event, click on the action icon () and Sign. The Signature page opens with the selected CRF. Click on the Sign icon (). Enter the Investigator credentials in the signature pop-up.
  • Option 2: From the Sign page.  All CRFs in the current Site that are eligible for signature are shown. To be eligible, CRFs must meet their source data verification requirements and have no open queries. CRFs are listed by Event completion date, with the oldest at the top of the page.
    To sign a CRF from the view below, just click on the Sign icon () for the desired CRF and enter the Investigator credentials in the signature pop-up.

Notes:

  • If the Sign icon is not present, make sure that the SDV requirements are met and check for open queries.
  • Scheduled events can be signed, even if no CRF data has been entered.  Signing at the Subject level will sign scheduled events.
Yes No Suggest edit
Last updated on May 22, 2019

6.10.3.Mass Signature

To apply a mass signature:

  1. From the Signature page, set the Sign Status filter to Not Signed.
  2. Check the CRFs to be signed.
  3. Click Sign All Checked.  The checkboxes under Sign Status are replaced by a Signed icon (). The signed status for the Event CRFs are logged in the Subject Audit Logs, along with the date, time, and name of the user that performed the data verification.

 

Yes No Suggest edit
Last updated on May 22, 2019

6.10.4.Monitoring Signature Progress

Available at a Site level for the role Investigator.

Depending on your role, you can customize your dashboard to display the Signature Progress widget. This widget allows you to quickly see, in a graphical format, how many CRFs are ready to be signed and how many have already been signed, over a period of time.

The graph bar for the current month can be clicked to go directly to the Signature page. Depending on the status selected, the page will be filtered to show only those CRFs that are available for signature or those that have been signed.

Yes No Suggest edit
Last updated on May 22, 2019

6.11.Open Build

Only available for the role Study Administrator, this option allows the user to manage the study back-end.

** Please, close any opened instance of Captivate Live before changing your Role or Study in the Captivate Build interface. **

For more information on Captivate Build, please refer to the  Captivate Build User Guide.

 

Yes No Suggest edit
Last updated on March 14, 2019

6.12.Help

From the Help menu, available to all the roles, users can access this user guide as well as several other web pages with more information on Captivate.

 

 

Contact Us

  1. Click Help in the Left Menu.
  2. Click Contact Us in the Help Menu,
  3. Fill out the provided form and click Submit.
  4. One of our Customer Success team members will be in touch with you shortly.

Note:

  • You may also call (800) 987-6007.
Yes No Suggest edit
Last updated on April 1, 2019

7.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.

Yes No Suggest edit
Last updated on May 20, 2019
Help Guide Powered by Documentor
Suggest Edit