Who should sign off on changes or corrections to CRFs made by sponsor-designated representatives?

• A. The investigator
• B. The sponsor
• C. The IRB
• D. The subject

Answer: (A)

The person responsible for the trial at the site must validate and attest to the accuracy of data in the CRFs. Even if sponsor-designated representatives make changes or corrections to the CRFs, the investigator (or someone officially designated by the investigator) must review and sign off on those edits. This ensures accountability and a reliable audit trail that the data reflect what actually occurred during the study.

The sponsor does not sign to certify the data, the IRB doesn’t approve individual data edits, and the subject isn’t in a position to verify trial data. So the investigator is the appropriate signatory to confirm that changes to CRFs are correct and properly documented.