Who should permit monitoring and auditing by the sponsor, and inspections by regulatory authorities?

• A. The sponsor
• B. The regulatory authorities
• C. The investigator/institution
• D. The IRB/IEC

Answer: (C)

The investigator/institution is the party that permits these oversight activities. In ICH GCP, the site conducting the trial must allow the sponsor’s monitoring and audits and must grant access to trial records, source documents, facilities, and essential data. This access is essential to verify compliance with the protocol, GCP, and regulatory requirements and to protect participant rights and safety. The sponsor coordinates and conducts monitoring, and regulatory authorities may inspect, but they rely on the investigator/institution to provide access and cooperation. The IRB/IEC oversees ethical aspects and approval of the study, not the authorization for monitoring, audits, or inspections.