Geographic Assignment Rollout allows Study Managers to assign new document version training to Learners in specific countries at different times while maintaining global compliance oversight. This feature is designed for global studies where site readiness and local regulatory approval vary by region.
Note: Geographic Assignment Rollout must be configured in Veeva Study Training Vaults. This feature is not supported for Veeva Training.
Use Case
A protocol document in Clinical Operations is up-versioned from v1.0 to v2.0, however protocol v2.0 is only currently approved for use in Italy, and will not be approved for the US until December. In the meantime, the Study Manager can use Geographic Assignment Rollout to update the matrix such that:
- Learners in Italy are immediately required to complete assignments for both v1.0 and v2.0. Alternatively, the Study Manager can opt to cancel v1.0 assignments and only require these Learners to complete v2.0.
- Existing and new Learners in the US train on v1.0 only, until December when the Study Manager assigns the requirement for protocol v2.0 to their section of the matrix.
Feature Impact
Geographic Assignment Rollout fundamentally changes Training Requirement Impact Assessment (TRIA) behavior for Training Requirements with CrossLinked Training Materials: Once the feature is configured, Vault no longer initiates the TRIA process for these CrossLinked documents. Instead, when a Study Manager updates a study’s Training Matrix to reflect regional training needs, the Study Training Matrix Builder replicates the TRIA process by prompting them to choose between cancelling related open assignments or requiring that Learners complete them.
About Historical Records
Vault Admins can configure Geographic Assignment Rollout without impacting existing Training Requirements and their related TRIA records: These records remain intact and Vault continues to track them as they are, referencing the latest approved CrossLink version. However, once a document is up-versioned after configuration is complete, the new behavior applies. As a result, we recommend implementing this feature before any training-sensitive CrossLink documents are up-versioned.
How Geographic Assignment Rollout Works
By default, updating a Training Requirement via the Training Requirement Impact Assessment (TRIA) process “stacks” document versions, where each new version modifies the existing requirement. This is the mechanism that simultaneously impacts all Learners assigned to that requirement, regardless of any regional training requirements.
With Global Assignment Rollout, Vault can instead “flatten” document versions, such that each new connection-transferred CrossLink document version is created in Study Training as a new requirement that Study Managers can adjust within a study matrix as needed.
This allows for more flexibility when, for example, a protocol document in Clinical Operations is up-versioned from v1.0 to v2.0, however protocol v2.0 is only currently approved for use in Italy, and will not be approved for the US until December. In this case, the Study Manager can use Geographic Assignment Rollout to update the matrix as follows:
Within the Italy section, remove the requirement for protocol v1.0, as it no longer applies in this region. Upon removal, the Study Training Matrix Builder’s Remove Training Requirement dialog prompts the Study Manager for a TRIA-like verdict to address outstanding v1.0 assignments. Then, Vault applies these verdicts once the matrix is published:
- Cancel open assignments means Learners must complete the new v2.0 assignment only.
- When selected, Vault deletes the corresponding Curriculum-Training Requirement relationship record, cancels any outstanding v1.0 assignments, and assigns v2.0 to all Learners.
- Require assignment completion means Learners must complete both their outstanding v1.0 assignment (if applicable) and the new v2.0 assignment.
- When selected, Vault transitions the corresponding Curriculum-Training Requirement relationship record to the Ineligible state, keeps open any outstanding v1.0 assignments, and assigns v2.0 to all Learners.
In parallel, the Study Manager removes requirement v2.0 from the US section, as that protocol version will not be applicable until December.
- In the meantime, the requirement still applies to the US, and so existing and new Learners complete their v1.0 assignments as normal.
- Once US Learners should begin training on this version later in the year, the Study Manager:
- Removes the requirement v1.0 from the US section and selects the Cancel open assignments or Require assignment completion verdict as required.
- Adds the requirement v2.0 back to the US section.
During this time, the Study Manager can additionally and optionally update either requirement v2.0’s Recognize Prior Completion field value to “Yes”. This option automatically satisfies the v2.0 requirement for any Learner who completed v1.0. It could be used, for example, if the protocol v2.0 reflects a minor update in Italy, and v1.0 training is sufficient for the protocol in this country overall. In this case, Learners in Italy would simply complete their v1.0 assignment (if not already complete) and automatically receive credit for v2.0 once assigned (as a result of the “Require assignment completion” verdict).
Note: Geographic Assignment Rollout does not support manually-created CrossLinks. While rare, these may be required, for instance, to train a CRO CRA in Study Training on an SOP from a Quality Vault. Geographic Assignment Rollout only supports CrossLinks created in Study Training via the Study Training-Clinical Operations Connection.
Configuration Overview
To configure Geographic Assignment Rollout:
- Within the Draft to Approved document lifecycle’s Approved state:
- Update the existing Create Related Training Requirement entry action with an additional condition for when CrossLink equals “No”. This configuration prevents Vault from automatically generating duplicate Training Requirements when the connection transfers a new non-CrossLink document version.
- Update the existing Set previous steady state to superseded entry action to be conditional based on when CrossLink equals “No”. This configuration allows consecutive CrossLink versions (v1.0, v2.0, etc.) to remain in the Approved state, ensuring all Learners are assigned the appropriate Approved-state version across regions.
- Update the Training Requirement-Curriculum object to use the standard Training Requirement-Curr Lifecycle.
- Update the Training Requirement object page layout for the Vault Document Training Requirement type to include the Recognize Prior Completion field.
- Optional: Create a new notification and add supporting configuration to let Study Managers know there is a new requirement available for review. To do this, you can either:
- Configure a new Action Trigger for the Matrix Section-Training Requirement object that sends a notification upon creation of a record.
- Configure an event action from the Training Requirement object lifecycle to send the notification or start a new custom review workflow (containing that notification) that you create to support your organization’s requirements.
- Review your Vault’s security configuration and ensure Study Managers have the appropriate permissions to work with this feature.
Note: This configuration assumes your Study Training Vault only uses the Draft to Approved document lifecycle for managing CrossLinked Training Materials. Vault Admins should ensure Step 1 above is properly reflected for similar lifecycles and states, if configured.
Limitations
- Study Managers must manually assign and remove impacted requirements within the Study Training Matrix Builder. This flow will be streamlined in a future release.
- Geographic Assignment Rollout does not support manually-created CrossLinks. While rare, these may be required, for instance, to train a CRO CRA in Study Training on an SOP from a Quality Vault. Geographic Assignment Rollout only supports CrossLinks created in Study Training via the Study Training-Clinical Operations Connection.
Related Permissions
Study Managers must be assigned a permission set with the below permissions to work with Geographic Assignment Rollout.
| Permission Label | Permission | Controls |
|---|---|---|
| Objects: Training Matrix Section | Read, Create, Edit | Removing a requirement from a section |
| Objects: Matrix Section-Training Requirement | Read, Create, Edit | Copying a requirement to another section |