You can configure actions to support document reconciliation between your Clinical Operations Vault and a site’s eISF in SiteVault to verify that both Vaults contain the same version of relevant Steady state documents.
When document reconciliation is triggered, Vault initiates a Document Reconciliation job, which compares all matched documents in both Vaults and creates Document Check records for each document. Note that the Document Reconciliation job runs asynchronously, meaning that there may be a delay before users see the new records. Users can then reconcile documents by sending documents and document requests to SiteVault.
Note: This feature is only available on Clinical Operations Vaults with Veeva Site Connect enabled.
Page Layout Configuration
Add the Site Document Checks and Document Checks related object sections to the applicable page layouts of the Monitoring Event and Study Site objects.
Lifecycle & Workflow Configuration
Study Site Lifecycle Configuration
- Configure the Perform Document Reconciliation system action in a workflow on the Study Site Lifecycle. Set the Allow auto-start from entry action and event action checkbox if you’d like to configure the workflow as an automatic entry action.
- Configure the Perform Document Reconciliation workflow to be available through a manual user action or automatic entry action on applicable states of the Study Site Lifecycle so that users can trigger document reconciliation on a Study Site record. We recommend labeling the action “Check Site Documents.”
Monitoring Event Lifecycle Configuration (CTMS)
- Configure the Perform Document Reconciliation system action in a workflow on the Monitoring Event lifecycle. Set the Allow auto-start from entry action and event action checkbox if you’d like to configure the workflow as an automatic entry action.
- Configure the Perform Document Reconciliation workflow to be available through a manual user action or automatic entry action on applicable states of the Monitoring Event lifecycle so that users can trigger document reconciliation on a Monitoring Event record. We recommend labeling the action “Check Site Documents.”
Document Check Lifecycle Configuration
- Configure the Send Doc/Request via Clinical Network user action on the Document Check Lifecycle so that users can send documents and request documents from Document Check records for documents that do not match in both Vaults.
- Configure the Change State to user action on the applicable states of the Document Check Lifecycle so that users can manually move open Document Checks to the Closed lifecycle state.
Job Notification Configuration
You can configure the Document Reconciliation job to send notifications to users when the job is complete.