Which statement about access to source data should be included in the protocol or written agreement?

• A. No access to source data is allowed
• B. Direct access to source data/documents for trial-related monitoring, audits, IRB/IEC review, and regulatory inspection
• C. Access only after subject consent
• D. Access after trial completion

Answer: (B)

Direct access to source data and documents by those responsible for trial oversight is required and should be described in the protocol or a written agreement. This ensures monitors, audits, IRB/IEC reviews, and regulatory inspections can verify the accuracy and integrity of the data and that the study is conducted in compliance with protocol and GCP. Access should cover source records (whether paper or electronic) and must be governed by appropriate privacy and confidentiality protections, with clear records of who accessed what and when.

Why the other ideas don’t fit: restricting access entirely prevents necessary verification and oversight; limiting access to after subjects have consented still delays or prevents timely monitoring and regulatory review; and granting access only after trial completion would miss opportunities to ensure data integrity and participant protection during the conduct of the study.