Question:
How to request permission to make destructive changes for a Study in Clinical Data?
Answer:
In order to temporarily allow for destructive changes for a study in Clinical Data that can be caused by Retrospective Amendments (used to update subjects to a new casebook version in production environments), please submit a ticket to Veeva support which includes the following information/attachments as formatted below:
- Production Vault ID:
- Study number:
- Summary of changes being made:
- Business reason for change:
- Expected business week to execute change:
- Count of forms and subjects affected by changes:
- Methodology used to determine the impacted forms:
- Attached difference report:
- Confirmation of approval:
Note: If the purpose of this change is to remove a component from the schedule, the recommendation is to instead use dynamic rules to do so as a workaround. Additionally, if no subjects have been enrolled, this process is not required.
Upon providing this information, Veeva support will relay to the relevant teams for approval to have the setting enabled.
Related Documentation:
Vault Help Documentation: Retrospective Amendments - Destructive Changes
Related Knowledge Article: How to Enable Destructive Changes for a Study in Clinical Data