Document reconciliation allows you to verify that relevant study documents exist in your Clinical Operations Vault and a site’s eISF in their SiteVault, ensuring that the site uses the appropriate documents to conduct the trial. When document reconciliation is triggered, Vault compares all transferrable Steady state documents and documents that have already transferred between Vaults via Veeva Site Connect and creates Document Check records for all documents that do not match. You can then send the latest Steady state version or request it from the site’s SiteVault.
Note: This feature is only available on Clinical Operations Vaults with Veeva Site Connect enabled. Some Admin configuration is required before you can utilize the document reconciliation feature in your Vault.
Triggering Document Reconciliation
Depending on the configuration of your Vault, you can trigger document reconciliation in several ways:
- Automatically, when a Study Site record moves to a specific lifecycle state.
- Automatically, when a Monitoring Event record moves to a specific lifecycle state (CTMS Vaults only).
- Manually, by selecting the option to check site documents from the Actions menu on a Study Site record after closing any open Document Check records.
- Manually, by selecting the option to check site documents from the Actions menu on a Monitoring Event record (CTMS Vaults only). This action overwrites any existing Document Check records associated with the Monitoring Event record. Note that there is only one set of Document Check records associated with a Monitoring Event at any given time.
When document reconciliation is triggered, Vault creates a parent Site Document Check record for each Study Site and Document Check child records for all transferrable Steady state documents and documents already transferred between Vaults via Veeva Site Connect. Vault creates records asynchronously, meaning that there may be a delay before you see the new records. If configured, Vault sends a notification when the job is complete.
Reviewing Document Verification Status
When document reconciliation is complete, you can review the verification status of all relevant documents in the document reconciliation section of the related Monitoring Event or Study Site record.
Reviewing Document Check in Study Sites
After the document reconciliation job completes, Vault lists all Site Document Check records in the related section of the Study Site record. Click on a parent record’s name to see all Document Check child records.
Reviewing Document Checks in Monitoring Events (CTMS)
After the document reconciliation job completes, Vault lists all Document Check records in the related section of the Monitoring Event record.
Review the status of each Document Check and determine if any actions are required to reconcile open records.
|Icon||Lifecycle State||Verification Status||Description|
|Closed||Matched||The same Steady state version of the document exists in both Vaults.|
|Open||Action Needed||The latest Steady state version of the document is missing from one or both Vaults.|
Reconciling Open Document Checks
To send the latest Steady state version of a document to the site or to request the latest Steady state version of a document from the site:
- Click on the Actions menu of a Document Check record.
- Select the option to reconcile documents.
- In the Send Document dialog, select an Action.
- Optional: Select a Due Date.
- Optional: Enter a Comment.
- Click Send.
- In the Send to Site(s) dialog, click Yes to send the document version or document request to the target SiteVault.
Closing Open Document Checks
You can manually move open Document Checks to the Closed lifecycle state. You may do this if, for example, you know that the site manually uploaded the latest Steady state version of a document to their SiteVault and so it does not need to be transferred via Veeva Site Connect. To do this, select the option to manually close from the Actions menu of a Document Check record.