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

This feature must be enabled on a study-by-study basis. See details below.


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 Permission Label Controls
Standard Tab 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

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.


Connect Vault to Absorb

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

Once your vault is connnected 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.

Enable the Integration for your Study

To enable the Veeva Learning Integration:

  1. Navigate to Tools > EDC Tools > Study Settings for your Study.
  2. Click Edit.
  3. For Enable Absorb Learning Integration, select Yes.
  4. 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 and CDMS User Administrators.
  • Vault sets the LMS Study Access field on all existing Users to Enabled. 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.

Add the Learning System to the Study

To add a Learning System to your Study:

  1. Navigate to Tools > EDC Tools > Learning Systems for your Study.
  2. Click + New Learning System.
  3. Select your Absorb connection for Existing Connection.
  4. Click Save.

Edit a Learning System

To edit a Learning System in your Study:

  1. Navigate to Tools > 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 Edit. Edit action

  4. Make your changes.
  5. Click Save.

Delete a Learning System

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

  1. Navigate to Tools > 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. Delete action

  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 Tools > EDC Tools > Learning Systems for your Study.
  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. You can download Veeva’s recommendations on curriculum assignments to standard Study Roles.

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 an appropriate curriculum for each role.

To assign curriculums:

  1. Navigate to Tools > EDC Tools > Learning Systems for your Study.
  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 to Study.
  6. Optional: To copy the changes to the curriculum mapping to other Studies:
    1. From the Save menu, select Save to Multiple Studies.
    2. In the Select Studies dialog, use the shuttle menu to move Studies from Available Studies to Selected Studies.
    3. Click Save to Multiple Studies.
    4. In the confirmation dialog, click** Save**. Vault copies your changes to the selected Studies. Vault only applies the changes (the delta) you’ve just saved to the other Studies. Vault does not update the other Studies to become an exact replica of the current study’s curriculum mapping.
  7. 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.

Copy Curriculum Assignments from Another Study

To assign curriculums by copying assignments from another Study:

  1. Navigate to Tools > EDC Tools > Learning Systems for your Study.
  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 twice daily at 12:00AM and 12:00PM, based on the Vault’s timezone. 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 Tools > EDC Tools > Learning Systems for your Study.
  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.

The training report includes the following information for each User:

  • Last Name
  • First Name
  • Email
  • Company
  • Absorb Username
  • Vault Username
  • User Status
  • Study
  • Study Role
  • Study Access
  • Site Access
  • Country Access
  • Training Required
  • Training Status
  • Date Assigned to Study
  • Last Modified Date
  • Curriculums Assigned
  • Courses Assigned (If this feature is enabled, see details below)
  • Training Completion Date

To generate a training report for a specific Study from EDC Tools:

  1. Navigate to Tools > EDC Tools > Learning Systems for your Study.
  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).

To generate a training report for all Studies in the current vault:

  1. Navigate to Tools > System Tools > Users.
  2. From the Actions menu, select User Training Report.
    Select User Training Report in the Actions menu
  3. In the User Training Report dialog, select All Studies.
    All Studies option
  4. Click Run.
  5. Vault begins a job to generate the training report. When finished, Vault sends you an email with a link to download the report (.zip).

To generate a training report for one or more Studies:

  1. Navigate to Tools > System Tools > Users.
  2. From the Actions menu, select User Training Report.
    Select User Training Report in the Actions menu
  3. In the User Training Report dialog, select Select Studies.
  4. Use the shuttle menu to move Studies from Available Studies to Selected Studies.
  5. Click Run.

Enable Course Completion Tracking 21R2 & Earlier

By default, Vault tracks training completion at the curriculum level. Each curriculum contains a number of individual courses. You can choose to have Vault track training completion at the course level and show those courses in the training report.

Enablement: This feature is enabled automatically in Studies created after the 21R3 release. Studies created prior to that release must enable this feature.

To enable this feature:

  1. Navigate to Tools > EDC Tools > Study Settings for your Study.
  2. Click Edit.
  3. For Include Absorb Course Details in the Training Report, select Yes.
  4. Click Save.