Unlocking Submitted Sample Transaction and Inventory Records
To help ensure sample data has a compliant, auditable trail, as required by PDMA and 21 CFR regulations, users cannot modify or delete submitted records for sample transactions, sample order transactions and sample inventories. However, sample admin users can unlock records as needed to correct mistakes or to archive old records. Any changes to sampling records are captured in the Vault audit trail, which maintains a historical record of edits and deletions for records on certain objects.
Who can use this feature?
- Browser Users
- Users do not require an additional license
- Sample Admin Users
Configuring Unlocking Sample Transaction and Sample Inventory Records for
Sample Admin Users
To configure this feature, ensure Configuring Sample Management is complete.
Unlocking Sample Transaction and Sample Inventory Records as
Sample Admin Users
Sample admin users can unlock records on the following objects:
- sample_inventory__v
- sample_transaction__v
- sample_order_transaction__v
Depending on the organization, business process and compliance rules may require users to capture a second HCP signature for changes to sample disbursements from call reports. If applicable, ensure users are aware of this requirement before the admin edits or deletes submitted sample transaction records.
To unlock a submitted record:
- Select the appropriate record.
- Select the Unlock action. This reverts the record to Saved status, so it is editable.
The Unlock action only displays for users with edit field permission to the unlock__v field and view access to the unlock__v object action, when the record is in submitted status. Only sample admin users should have access to this field.
- Make the appropriate changes to the record.
- Select Submit to resubmit the edited record.
When an admin edits or deletes a submitted sample_transaction__v or sample_order_transaction__v record, changes are captured with Vault's audit trail functionality. For more on viewing audit trails in Vault, see Viewing the Audit Trails.
Unlocking Sample Disbursements
When a call with existing sample_transaction__v disbursement records is submitted, additional disbursement records are not created for the call. This ensures duplicate sample transactions are not created when an admin unlocks and then resubmits a call report.
