Managing Study Settings

There are certain study-level settings that you can enable and disable from EDC Tools. Note that your selections in EDC Tools > Study Settings aren’t versioned.

Prerequisites

Required Permissions

Users with the standard CDMS Lead Data Manager, CDMS Librarian, CDMS Study Designer, CDMS User Administrator, and CDMS Super User can perform the actions described below by default. If your organization uses custom Study Roles, your role must grant the following permissions:

Type Permission Label Controls
Standard Tab EDC Tools Tab

Ability to access the EDC Tools tab
Functional Permission Edit Study Settings

Ability to edit the Study Settings available in EDC Tools

Accessing EDC Tools

To access the EDC Tools administration area, click the Tools tab in the primary navigation bar, and then click EDC Tools.

This opens the My Studies page. Click the Name of your Study to open it. This opens the Study Environments page. Click the Name of the Environment to open it.

By default, when you open the Environment, EDC Tools is open to the Study Settings page.

Available Settings

The following settings are available to manage in EDC Tools > Study Settings:

Enable Learning System

Use this setting to enable or disable the Vault Training LMS Integration feature (integration with Vault Training, Veeva’s LMS). There is additional configuration required post-enablement before you can use this integration.

Option Default Description
Yes

Select Yes to enable the LMS Integration.

This automatically selects Yes for Include Course Details in Training Report.
No

Select No to disable the LMS Integration.

Include Course Details in the Training Report

Use this setting to choose whether to have Vault track training completion at the course level and show those courses in the training report.

Option Default Description
Yes

Select Yes to enable Course Completion Tracking. This adds additional columns to the training report.

This option is selected automatically when you select Yes for Enable Learning System.
No

Select No to disable Course Completion Tracking.

Connect to Vault CTMS

Use this setting to enable or disable the Vault CTMS Connection feature.

Option Default Description
Yes

Select Yes to enable the Vault CTMS Connection. This allows your organization to set up a connection with your CTMS vault.
No

Select No to disable the Vault CTMS Connection.

If you selected Yes for Connect to Vault CTMS, you must enter a CTMS Study Link ID. Vault uses this value to identify the matching Study in CTMS. Ask the administrator of your organization’s CTMS vault for this value.

Enable Bulk Casebook Signature

Use this setting to enable or disable the Bulk Casebook Signature feature.

Option Default Description
Yes

Select Yes to enable Bulk Casebook Signature. This allows Principal Investigators to sign multiple casebooks at once.
No

Select No to disable Bulk Casebook Signature.

Enable Sign with Open Queries

Use this setting to enable or disable the Sign with Open Queries feature.

Option Default Description
Yes

Select Yes to enable Sign with Open Queries. This allows Principal Investigators to sign Forms and Event Dates with open queries.
No

Select No to disable the Sign with Open Queries feature.

Disable Manual Casebook Creation

Use this setting to control whether users are allowed to manually create new Casebooks in the Data Entry tab. You may want to disable casebook creation when using an external integration with Interactive Response Technology (IRT) to create Casebooks.

Option Default Description
Yes

Select Yes to disable manual creation of Casebooks. This disables the + New Casebook button in the Data Entry tab.
No

Select No to allow users to create Casebooks manually. This enables the + New Casebook button in the Data Entry tab.

How to Edit Settings

To edit your study’s settings:

  1. Navigate to Tools > EDC Tools > Study Settings for your Study.

  2. Click Edit.

  3. Make your changes.

  4. Click Save.

Because these settings aren’t versioned, they apply right away, but you must make your desired changes in each environment.