You can reopen and revise an approved Case before it is submitted to health authorities.
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
About Reopening Cases
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.