Getting Started

Learn the basics about using RTSM, how to access reports, and how to request help.

Data Change Request Process

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 Process

Data Change Request Process

Data Change Request Form

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

Find Data Change Request Form

Note: The above Help tab is from System Version 1-4

Find Data Change Request Form - 23R1

Note: The above Help tab is for System Versions post 23r1

DCR Approval Requirements

Veeva and the Sponsor/CRO have indicated on the DCR form the types of changes that may be requested, and which of those require a customer signature

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

Data Change Request Form - Sponsor Approval

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

Filling out the DCR Form

Data Change Request Form - Sponsor Approval

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

RTSM