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About Case Approval
Approved Cases are fully processed and ready for submission to the health authorities. When a Case is approved, the system locks the Case to prevent any changes prior to submission.
Once a Case is locked, you can’t make further changes to the case without initiating a Case Revision workflow or creating a Follow-Up Case.
Note This page describes the Approval task in the default Case Processing workflow. If your organization has a custom workflow, follow the recommendations in your business standard operating procedure for approving cases.
Requirements
- For expedited Cases, the Medical Review task must be complete.
- For non-expedited Cases, the QC task must be complete.
- You must be assigned the Head of Safety role.
Start the Approval Task
- To accept an Approval task, go to Home > Available Tasks, and then in the row for the task that you want to complete, select
.
You can also accept the task from the Case page. If you don’t see the task available, it may be assigned to another user or role. - Go to Home > My Tasks, and then select the Case name link that you want to review.
The Case page appears. - Review the Case.
- In the Approval task banner, select
.
The Approval window appears.
Approve a Case
- In the Approval window, select Approved.
- (Optional) Under Comments, enter any relevant comments about the Case or approval.
- Select Complete.
Result
The case advances to the Approved state and is locked to prevent further changes.
Send a Case for Medical Review
- In the Approval window, select Requires Medical Review.
- Under Instructions, enter the reason the Case requires another round of medical review.
- Select Complete.
Result
The system assigns a new Medical Review task to the appropriate user or role.
Send a Case Back to Data Entry
- In the Approval window, select Requires Data Entry.
- Under Instructions, enter the reason the Case requires more data entry.
- Select Complete.
Result
The system creates new Data Entry task.
