Who should retain records of the changes and corrections to CRFs?

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

Answer: (A)

The investigator keeps records of changes and corrections to CRFs because they are responsible for the accuracy and integrity of the data collected at the trial site. Each modification to a CRF entry should be traceable—noted with the date, reason for the change, and the initials or identifier of the person making the change—and maintained as part of the trial’s essential documentation. This ensures that audits and inspections can verify that data were collected and amended correctly and in compliance with the protocol and GCP. While the sponsor may maintain data copies and oversee data management, the formal retention of CRF change logs belongs to the investigator. The IRB/EC and the trial subject do not hold these site-level data-change records.