Training records captured in Study Training Vaults are key trial artifacts relevant to an organization’s trial master file in Veeva eTMF. To support this relationship and eliminate manual processes for filing training records to eTMF, Study Training Vaults can automatically generate and store both site and trial team training reports (logs) as Library documents, then transfer them to eTMF as CrossLinks.
Note: This feature is available in connected Study Training and eTMF Vaults only, and must be configured by a Vault Admin.
How Vault Auto-Files Study Training Logs to eTMF
Study Training Vaults include two standard multi-pass reports, Matrix Assignments: Site Evidence of Training and Matrix Assignments: Trial Team Evidence of Training. These are the Veeva-recommended reports, however your organization may use a custom report.
When the Send Training Evidence to eTMF action is initiated from a Study record as an entry action or user action, Vault:
- Runs the Study Training report and files the output under the corresponding Study Training document type.
- Vault manages the document according to its configured lifecycle. When configured to use the Veeva-recommended Draft to Approved lifecycle, Vault automatically transitions the document to its Approved (Steady) state.
- Similar to the above, when the action is run multiple times for a given study and an eTMF CrossLink already exists, Vault up-versions the existing document and transitions it to its configured Steady state.
- Vault uses the Generate Document From Report SDK job to generate and file the report output. This job fails when the intended document type’s lifecycle is not configured with a Steady state type.
- Training Admins and others with access can also view the reports at any time under Reporting & Dashboards.
- Initiates the Study Training Vault’s Send Study Training Reports to eTMF SDK job. This prompts the Study Training to Clinical Operations Vault Connection to send the document to the eTMF Vault as a CrossLink, via the connection’s Study Training Materials Outbound Integration Point.
- Once received by the eTMF Vault’s Study Training Materials Inbound Integration Point, Vault files the report output document CrossLink under the corresponding eTMF document type.
Note: This feature requires that any Vault-generated documents remain in their Steady state. It is important that these documents are not obsoleted or retired in the Study Training Vault.
Default Document Types
By default, this feature references the below Study Training and eTMF document types to store training report output documents. Vault determines the appropriate eTMF document types based on the inbound Integration Point’s target key, which a Vault Admin can update to map to different eTMF document types.
- Study Training standard document types:
- Trial Team Evidence of Training (
trial_team_evidence_of_training__v) - Site Evidence of Training (
site_evidence_of_training__v)
- Trial Team Evidence of Training (
- eTMF custom document types:
- 01 Trial Management (
trial_management__c) > Meetings (meetings__c) > Trial Team Evidence of Training (trial_team_evidence_of_training__c) - Site Management (
site_management__c) > Site Initiation (site_initiation__c) > Site Evidence of Training (site_evidence_of_training__c).
- 01 Trial Management (
Configuration Overview
To configure Vault to Auto-File study training logs to eTMF, follow the steps below. This configuration should be completed in your Study Training Vault, unless otherwise indicated.
- Review your Vault’s document type and lifecycle configuration in Admin > Configuration > Document Types. For each of the default document types Vault uses to store Study Training reports:
- Select Edit Details for the document type.
- In the General tab’s Available Lifecycles, select the lifecycle you’d like to use for the report output. By default, the Veeva-recommended Draft to Approved lifecycle appears in grey, however you must re-select this or another lifecycle so that it appears in blue.
- Navigate to Admin > Configuration > Document Lifecycles. For the lifecycle selected in Step 1, ensure:
- There is a state mapped to the lifecycle’s Steady State type. This is required to ensure the standard Generate Document From Report SDK job can create and file the report output.
- It is not possible to obsolete or retire the Vault-generated output document using the selected lifecycle. This feature requires that any such Library documents remain in their Steady state.
- Navigate to Admin > Configuration > Objects. Within the Study object, create an action using the standard Send Training Evidence to eTMF action.
- During configuration, ensure you do not select the Available in All Lifecycle States option. To resolve this, simply delete the action and re-create it.
- When this configuration is enabled, you cannot select any reports when configuring the action within the Study object lifecycle as described in Step 4. Additionally, if left unaddressed, Vault defaults to sending the standard reports in all Study lifecycle states.
- Navigate to Admin > Configuration > Object Lifecycles. Within the Study Lifecycle, select the lifecycle state for which you’d like to send the reports via entry action. While you can select one or more lifecycle states, we recommend using the Closing state (
closing_state__v). Then, configure an entry action using the Send Training Evidence to eTMF action. During configuration, Vault populates the Report for Site Evidence and Report for Trial Team options with the standard recommended reports.- To opt out of sending a report, select Not Applicable.
- To send a different report, see additional details about configuring a custom report.
- Optional: Configure a user action using the Send Training Evidence to eTMF action. The state(s) you select can be different from those configured in Step 4, as a user action is primarily recommended for sending reports ad-hoc, for reasons unrelated to the Study’s lifecycle state.
- Review your Vault’s security configuration and ensure users are assigned the appropriate permissions.
- Navigate to Admin > Connections > Study Training to Clinical Operations Connection > Integrations > Study Training Materials Integration. Under Integration Points - Outbound, update the Study Training Materials Outbound Integration Point Status to “Active”.
- Optional (eTMF): Review your Vault’s document type configuration. By default, this feature uses specific eTMF document types to store Study Training report CrossLinks. To store the reports elsewhere:
- Update the connection’s
document_type__sysReference Lookup to use the new document type(s), according to its Target Key. - Ensure the document type is properly assigned a corresponding lifecycle, and that the lifecycle has a state mapped to its Steady State type.
- Update the connection’s
- In eTMF: Navigate to Admin > Connections > Study Training to Clinical Operations Connection > Integrations > Study Training Materials Integration. Under Integration Points - Inbound, update the Study Training Materials Inbound Integration Point Status to “Active”.
- In eTMF: Navigate to Admin > Configuration > Objects. Within the User Exception Message object, create an action using the standard Retry Study Training Transfer action. This allows Vault to retry any failed document transfers.
About Custom Reports
By default, this feature uses the Veeva-provided Matrix Assignments: Site Evidence of Training and Matrix Assignments: Trial Team Evidence of Training multi-pass reports. Though we highly recommend using these read-only reports, a Vault Admin can configure custom reports for the same purposes.
When configuring any custom reports and their related lifecycle entry actions or user actions, consider the following additional configuration parameters:
- To take full advantage of this feature, there should be two reports for capturing both site and trial team evidence of training.
- Custom reports must be created using the Matrix Training Assignments report type.
- When configuring the Study object lifecycle to Send Training Evidence to eTMF via user and/or entry action (Step 4), ensure you select the correct custom report within the Report for Site Evidence and Report for Trial Team options.
Limitations
The below limitations apply to this feature:
- This feature requires that any Vault-generated documents remain in their Steady state. It is important that these documents are not obsoleted or retired in the Study Training Vault.
- As of 25R1, this feature does not support Training Assignments created via Direct Assignment or Self-Enrollment, as indicated by the assignment’s Creation Source field. This capability will be supported in a future release. In the meantime, organizations who would like to store these types of training records can create a report and manually file it in the eTMF Vault.
Related Permissions
To use this feature, users must be assigned a permission set with the below permissions.
| Permission Label | Permission |
|---|---|
| Objects: Study: Object Action Permissions: Send Training Evidence to eTMF | Ability to view the user action on Study records. |
| Objects: Study: Object Action Permissions: Send Training Evidence to eTMF | Ability to execute the user action on Study records. |