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 and sample inventories. However, admins can unlock records as needed to correct mistakes or for archiving old records. Any changes to sampling records are captured by audit records, which maintain a historical record of edits and deletions for records on certain objects.
For example, Sarah Jones inadvertently selects the wrong sample lot number on the call report and submits the call. As a user, Sarah cannot edit the submitted record, so she contacts Alice Adams, a sample admin. Alice unlocks the appropriate disbursement record and corrects the sample lot number. The change is automatically recorded via a sample transaction audit record.
Ensure initial configuration is complete to use this functionality.
Unlocking Sample Transaction and Sample Inventory Records
Admins can unlock records on the following objects:
For more information on these objects, see Components of Sample Management.
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 button. This reverts the record to Saved status, so it is editable.
The Unlock button only displays for users with FLS edit permission to the Unlock_vod field. Only admins 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 or Sample Transaction Order record, a new record is automatically created via Apex triggers on the Sample_Transaction_Audit_vod or Sample_Order_Transaction_Audit_vod object, respectively. For more information on data security and audit records, see Maintaining Sample Data Integrity.
Unlocking Sample Disbursements
When a call with existing Sample Transaction 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.