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.

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 connected 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.

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.

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.

To assign curriculums:

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

2. Click Absorb. Vault opens the Absorb page.

3. From the Actions menu, select Edit.
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. From the Actions menu, select Copy From Study.
4. In the Copy From Study dialog, select a Study to copy from.
5. Click Copy.

Export Curriculum Assignments

You can export your curriculum assignments to an Excel™ file. You can use this file for offline review or to import your mappings into another Study.

To export:

1. Navigate to Tools > EDC tools > Learning Systems for your Study.
2. Click Absorb. Vault opens the Absorb page.
3. From the Actions menu, select Export to File.
4. Vault generates an Excel™ file of your curriculum assignments as they exist at the time of export. Review this file in Microsoft Excel™.

You can edit the file and then import it into this or another Study to apply the assignments. Enter “Yes” in the cell for the appropriate curriculum and role.

Import Curriculum Assignments

After exporting, you can edit the file and then import it into a Study to apply the assignments. Enter “Yes” in the cell for the appropriate curriculum and role.

1. Navigate to Tools > EDC tools > Learning Systems for your Study.
2. Click Absorb. Vault opens the Absorb page.
3. From the Actions menu, select Load from File.
4. In the Load from File dialog, click in the File field.
5. Browse for and select your file.
6. If you have existing assignments, you can choose how to handle changes:
   • Select Add supplemental selections from file to add additional curricula to the role’s assignments.
   • Select Update strictly from file to overwrite any existing assignments and use only those in the file.
7. Click Load.
8. Vault shows your changes in the grid in edit mode. Review the changes.
9. When finished, click Save to Study.
10. Optional: To copy the changes to the curriculum mapping to other Studies:
    • From the Save menu, select Save to Multiple Studies.
    • In the Select Studies dialog, use the shuttle menu to move Studies from Available Studies to Selected Studies.
    • Click Save to Multiple Studies.
    • 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.
11. Click Cancel to return to EDC Tools > Learning Systems.

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.

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.

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.

   

3. In the User Training Report dialog, select All Studies.

   

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.

   

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.

Troubleshooting

The sections below outline troubleshooting steps for certain integration scenarios. These steps must be performed by a user with the Vault Owner security profile.

Training Mapped Prior to User Creation

We recommend that you perform all training mapping prior to creating users.

However, if you created Users before you mapped your training curricula, you must manually update the LMS Training Status for those Users to Not Trained.

1. Navigate to Admin > Business Admin > CDMS Application Role Permissions. Ensure that you are using the All CDMS Application Role Permissions view.
2. Editing the columns displayed may help you find the users you want to update. To edit the columns:
   1. From the Actions menu, select Edit Columns.
   2. Use the Arrow buttons to move Study Master, Role, and LMS Training Status from Available Columns to Selected Columns.
   3. Click Save.
3. Use filters to narrow the list as necessary.
4. Click the Name of the row you want to open.
5. Click Edit.
6. For LMS Training Status, select Not Trained.If the user has already completed their assigned training in Veeva Learning, Vault will automatically update this to Trained.
7. Click Save.

If you’re updating many users, consider using a bulk action to edit the field.

Changed Email Address Resulted in Multiple LMS Accounts

If you change a user’s email address in Vault CDMS, after they’ve already had an account created in Veeva Learning, Vault creates a second Veeva Learning account for that user.

If the user only completes their training in one Veeva Learning account, CDMS Support can simply inactivate the unnecessary account. If the user has completed training across multiple Veeva Learning accounts, CDMS Support can merge the accounts and preserve the users training completion.

Once CDMS Support has addressed any issues in the Veeva Learning system, a Vault Owner must ensure that the user’s account has the correct eLearning ID (tracked in the External ID field on the Learning System User object).

To verify the eLearning ID:

1. Get the user’s eLearning ID from CDMS Support.
2. Navigate to Admin > Business Admin > Learning System Users. Ensure that you are using the All Learning System Users view.
3. Editing the columns displayed may help you find the users you want to update. To edit the columns:
   1. From the Actions menu, select Edit Columns.
   2. Use the Arrow buttons to move User, Study, and External ID from Available Columns to Selected Columns.
   3. Click Save.
4. Locate the User you want to edit. You can use the search bar. There is one row per study and role combination for each User, so a User may have multiple rows.
5. Click the user row’s Name to open the record.
6. Click Edit.
7. Verify that the External ID value matches the eLearning ID. If not, enter the eLearning ID in the External ID field.
8. Click Save.