Using the Veeva Learning Integration


You can use the Veeva Learning integration to prevent users from accessing a Study before they have completed the appropriate product training. Vault CDMS integrates with the Veeva Learning Management System (Absorb). You can assign Veeva Training courses to specific Study Roles, including custom roles, from EDC Tools > Learning Systems. Users with those Study Roles will be required to complete the assigned courses before they can view study-related records in Vault CDMS. Until they have completed their training, Vault CDMS marks their Study Access as Disabled. Once training is complete, Vault CDMS updates their Study Access to Enabled.

Prerequisites

The enablement for the Veeva Learning Integration is controlled by a study-level feature flag on the Study Configuration object.

To enable the Veeva Learning Integration:

  1. Navigate to Admin > Business Admin > Study Configurations.
  2. In the object record list, locate the Study Configuration record for your Study.
  3. Click to open the Study Configuration record.
  4. Click Edit.
  5. In the Enable Learning System field, select Yes.
  6. Click Save.

Once you click Save, Vault performs the following actions:

  • Adds the Learning Systems area to EDC Tools. This tab is visible by default to CDMS Lead Data Managers, CDMS User Administrators, and EDC Lead Data Managers.
  • Adds the Manage Learning permission to the Role Management table and assigns it to the CDMS Lead Data Manager and CDMS User Administrator study roles.

Vault sets the LMS Study Access field on all existing Users to Enabled and the Ignore LMS Training Status field to Yes. This prevents users from being locked out of your study upon feature enablement. Any users that you add after enabling this feature will not have study access before completing their training.

The Veeva Learning Integration is now enabled for your Study. Lead data managers can now add Curriculums and assign them to Study Roles.


The following permissions are required to perform the actions described below.

Which permissions control your access depends on when your vault was created. If your vault uses the Role by Study feature, see the first section, Role by Study Permissions. If your vault does not use the CDMS Role by Study feature, see the second section, Profile Permissions.

Role by Study Permissions

Users with the CDMS Lead Data Manager and CDMS User Administrator study roles can perform the tasks above in EDC Tools by default.

Users must have the Vault Owner security profile to enable this feature.

If your vault uses custom Study Roles, your role must grant you the following permissions:

Type Permissions Controls
Functional Permission EDC Tools Tab Ability to access the EDC Tools tab
Functional Permission Manage Learning Ability to assign learning system curriculums to Study Roles from EDC Tools
Security Profile Objects: Study Configuration: Edit Ability to edit records in the Study Configuration object (enable the Veeva Learning Integration feature)
Security Profile Objects: Curriculum: Create, Edit Ability to create and edit records in the Curriculum object

Profile Permissions

Users with the Vault Owner security profile are able to perform all of the actions described above by default.

If your vault uses custom security profiles, your security profile must grant you the following permissions:

Type Permissions Controls
Security Profile EDC: Study Tools: Access Ability to access and use the EDC Tools area
Security Profile Objects: Study Configuration: Edit Ability to edit records in the Study Configuration object (enable the Veeva Learning Integration feature)
Security Profile Objects: Curriculum: Create, Edit Ability to create and edit records in the Curriculum object

Learn more about permission sets.


Connect Vault to Absorb

Before you can add and assign training, a Vault Owner must first create a Connection between your vault and the Absorb system. Work with your Veeva Services representative to create this connection.

Learn how to create a Connection here.

Once you create a connection to Absorb, Vault performs the following actions:

  • Creates a Learning System object record for Absorb.
  • Creates a Curriculum object record for each Veeva Training course.

If at any time you need to delete the Learning System, you can do so. To delete a Learning System:

  1. Navigate to EDC Tools > Learning Systems for your study.
  2. Hover over the Learning System you want to delete to show the Actions menu.
  3. From the Actions menu, select Delete.
  4. In the confirmation dialog, click Delete.

Deleting the Learning System removes all curriculum assignments for your Study.

Add Curriculums

Before you can assign curriculums to Study Roles, you must first add all available curriculums from Veeva Learning.

To add curriculums:

  1. Navigate to EDC Tools > Learning Systems.
  2. Click Absorb. Vault opens the Absorb page.
  3. Click Add Curriculum.

Vault adds all available curriculums from Veeva Learning to your vault as records in the Curriculum object. You can now assign these curriculums to Study Roles.

Assign Curriculums to Study Roles

You can assign curriculums (training courses) to Study Roles from EDC Tools > Learning Systems.

EDC Tools > Learning Systems

If your organization uses custom Study Roles that require courses from multiple role curriculums, contact Veeva Training and work with them to create appropriate an appropriate curriculum for each role.

To assign curriculums:

  1. Navigate to EDC Tools > Learning Systems.
  2. Click Absorb. Vault opens the Absorb page. Open Learning System

  3. Click Edit. Edit button

  4. For each Curriculum, select one or more Study Roles to assign it to.
  5. When finished, click Save.
  6. Click Cancel to return to EDC Tools > Learning Systems.

The curriculums are now assigned to the chosen Study Roles. The assignment is recorded in the Application Role Curriculum object.

To assign curriculums by copying assignments from another Study:

  1. Navigate to EDC Tools > Learning Systems.
  2. Click Absorb. Vault opens the Absorb page.
  3. Click Copy From Study.
  4. In the Copy From Study dialog, select a Study to copy from.
  5. Click Copy.

Training in Absorb

Once you assign curriculums to your Study Roles, Veeva Training automatically creates accounts for new users in your Study and assigns them the appropriate courses.

Go to Veeva Learning

Get Enrollment

By default, Vault CDMS checks if users have completed their training daily at 9:00 PM (Pacific). If a user has completed all of their assigned courses, Vault updates their Study Access to Enabled (by setting their LMS Training Status to Trained and their LMS Study Access to Yes).

You can also check course completion on an ad hoc basis using the Get Enrollment action.

To get enrollment:

  1. Navigate to EDC Tools > Learning Systems.
  2. From the Actions menu, select Get Enrollment. Get Enrollment action

  3. Vault starts a job to check if users have completed their assigned coursework. If a user has completed their courses, Vault updates their Study Access to Enabled.

Vault records course completion in the Enrollment Completion object. Once a user completes a course, Vault records the completion date in the Enrollment Completion record for that course and user.

Reporting on Training

From time to time, you may want to report on your organization’s training progress. You can easily do that by exporting a training report. The training report is a set of CSV files that list a user’s training progress, including their assigned curriculums, the completion date of each curriculum, and whether their study access is disabled or enabled.

To generate a training report:

  1. Navigate to EDC Tools > Learning Systems.
  2. From the Actions menu, select Generate Training Report. Generate Training Report action

  3. Vault begins a job to generate the training report. When finished, Vault sends you an email with a link to download the report (.zip).