Data Changes

• A data change is required when data entered or generated in the system needs to be modified
  • When possible, changes must be made by the user in the Veeva RTSM system
• A Data Change Request (DCR) is necessary when data needs to be modified and the user is unable to modify it in the Veeva RTSM system
• Veeva requires the site to complete a DCR form detailing the requested changes
• All DCRs are managed using the Veeva GSC (help desk)
• Veeva prioritizes any urgent DCRs and may execute prior to obtaining a customer signature if a patient is waiting or the patient’s safety is at risk

 Data Change Request (DCR) Process

 Data Change Request Form

A Data Change Request form is located on the Help page of Veeva RTSM.

• Navigate to the RTSM Help Page
• Select View to open the study-specific DCR form from the User Documentation section on the Help Page
• A new window will open with the form
• Print the DCR form and legibly write in all required details

System Versions post 25r1

System Versions post 23r1

System Version 1-4

 DCR Approval Requirements

Veeva and the Sponsor/CRO have indicated on the DCR form the types of changes that require Sponsor Approval.

If a signature is required, the change is not run until Veeva collects the customer signature.

NOTE: Data change types and approval requirements vary by study.

Filling out the DCR Form

Once the form is filled out completely, email the form to rtsmdcr@veeva.com