Revise an Approved Case

Start a Case Revision workflow to update an approved Case before it is submitted to health authorities.

About Case Revisions

When a Case is approved, the Case and all of its related data transitions to a locked state, preventing unapproved updates. At this stage, the only way to update the Case is to start the Case Revision workflow.

The Case Revision workflow allows you to add non-significant updates before submitting the case, such as non-significant follow-ups. If the updates impact a report previously distributed to health authorities or partners, you can amend a safety report.

For significant updates that require additional processing, create a Follow-Up Case.

Unlock a Case

1. Go to the Cases tab.
2. Select the name of the Case to open it. The Case must be in the Approved state.
3. On the Case page, expand the Workflow State Change () menu, and then select Start Revision.

Result

The system unlocks the Case and all of its related data. The Case enters the Revision state.

Revise a Case

1. If you have not accepted the Revision task, select Accept in the Revision task banner. If you do not see a Revision task banner, the task may be assigned to a different user or role.
2. Add the new or changed information, and then save the case.
3. In the Revision task banner, select Complete. The Revision window appears.
4. In the Summary of Changes field, enter a description of the changes.
5. Select one of the following verdict options:
   • To send the changes through a quality control review, select Requires QC.
   • To send the changes through a medical review, select Requires Medical Review.
   • To skip the review cycle and send the changes for approval, select Complete.
6. Select Complete.

Result

The system assigns a workflow task to the appropriate participant to review or approve the revision, depending on the verdict that you select.