Which statement best describes the role of the investigator regarding monitoring and auditing?

• A. The sponsor
• B. The investigator/institution should permit monitoring and auditing by the sponsor and inspections by regulatory authorities
• C. The regulatory authorities
• D. The IRB/IEC

Answer: (B)

In Good Clinical Practice, the investigator must cooperate with oversight by allowing access for monitoring, auditing, and regulatory inspections. The sponsor (or their designee) conducts monitoring to verify that the study is being conducted and data are recorded correctly, while regulatory authorities perform inspections to ensure compliance with GCP and applicable laws. The investigator and the institution are responsible for permitting these activities and providing access to source documents, records, and facilities as needed. This cooperation helps ensure participant safety, informed consent is properly obtained and documented, and the trial is conducted according to the protocol. The IRB/IEC focuses on ethical oversight and participant protection, but the ongoing requirement to permit sponsor monitoring and regulatory inspections remains a distinct and essential obligation of the investigator.