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How to Request Permission to Make Destructive Changes CDMS?

  • Updated

Question:

How to request permission to make destructive changes in CDMS?

Answer:

In order to temporarily allow for destructive changes in CDMS that can be caused by Retrospective Amendments 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:
  • Are any of them frozen or signed: 
  • Attached extract or listing of the impacted forms:
  • Attached difference report:
  • Attached written approval (approval must also include the total count of subjects/forms affected):

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.

Upon providing this information, Veeva support will relay to the relevant teams for approval to have the setting enabled.

Once the Veeva team enables the Vault to allow destructive changes, the study must be enabled as well by following these steps: How to Enable Destructive Changes in a Study for CDMS

Related Documentation:

Vault Help Documentation: What's New in 22R3

Related Knowledge Article: How to Enable Destructive Changes in a Study for CDMS

 

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