Investigators must permit which activities?

• A. Only sponsor
• B. No external oversight
• C. Monitoring, auditing, and inspection
• D. Only IRB

Answer: (C)

Under ICH GCP, investigators must allow trial-related monitoring, audits, and inspections. These oversight activities are essential to protect participants and ensure data integrity. Monitoring may be conducted by the sponsor or their designate to verify compliance with the protocol and consent processes and to check source data. Audits are formal examinations to assess overall compliance with the protocol, GCP, and regulatory requirements, and can be performed by the sponsor or regulatory authorities. Inspections are carried out by regulatory authorities, and the IRB/IEC may also require or participate in such inspections. Because of this, restricting oversight to only one party or denying external oversight would not align with GCP expectations. Therefore, the investigator must permit monitoring, auditing, and inspection.