When a Case is approved, Vault locks the Case and all of its related data to prevent unapproved updates. The Reopen Case workflow allows you to add non-significant updates before submitting the case, such as non-significant follow-ups.
You can reopen and revise an approved Case only if it does not include any Transmissions in the following states:
- Completed
- E2B ACK Accepted
- Sent
- Sending ICSR
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.
Reopen a Case
To reopen an approved Case:
- Navigate to the Cases tab and select a Case in the Approved state.
- From the Workflow and State Change (
) menu, select Reopen Case Version.
Result
Vault unlocks the Case and all of its related data. The Case enters the Revision state and you can enter revisions.
Revise a Case
To revise a Case in the Revision state:
- Select Edit.
- Enter the new or changed information.
- Select Save.
- In the Make Necessary Changes task banner, select Complete.
- In the Make Necessary Changes dialog, select Complete.
Result
The Case enters the In Approval state and you can complete the Approval workflow.