On request from monitor, auditor, IRB/IEC, or regulatory authority, what should the investigator do?

• A. Notify the sponsor only.
• B. Archive records and deny access.
• C. Make available for direct access all requested trial-related records.
• D. Provide copies to the sponsor only.

Answer: (C)

In GCP, investigators must permit direct access to all trial-related records by monitors, auditors, IRBs/IECs, and regulatory authorities. This direct access is essential so oversight bodies can verify that the trial is conducted, recorded, and reported accurately and in compliance with the protocol and applicable regulations. Direct access means the reviewer can inspect and copy source documents, case histories, regulatory files, informed consent forms, and other essential records at reasonable times and places, whether on-site or in electronic systems, while maintaining appropriate confidentiality.

That’s why this option is the best: it fully supports oversight and data integrity by allowing the requested parties to review the actual records, not just provide a copy to the sponsor or deny access. Providing access only to the sponsor would limit necessary oversight, and archiving records while denying access would prevent verification of compliance. Providing copies to the sponsor alone likewise fails to meet the need for independent review by monitors, IRBs/IECs, or regulators.