Which oversight activities should the investigator permit?

• A. Only sponsor monitoring is allowed.
• B. Monitoring and auditing by the sponsor, inspection by regulatory authorities, and review by IRB/IEC(s) should be permitted.
• C. IRB/IEC reviews are optional for trials.
• D. Regulatory inspections may occur, but sponsor monitoring is not permitted.

Answer: (B)

Oversight of a clinical trial involves several bodies working to protect participants and ensure data integrity. The investigator should permit monitoring by the sponsor, audits by the sponsor, inspections by regulatory authorities, and reviews by the IRB/IEC. Each of these oversight activities serves a distinct role: sponsor monitoring verifies adherence to the protocol and GCP; sponsor audits check accuracy and procedures; regulatory inspections assess compliance with applicable laws; and IRB/IEC reviews ensure ongoing protection of participants’ rights and welfare and monitoring of study conduct. Limiting oversight to only sponsor monitoring, treating IRB/IEC reviews as optional, or stating that sponsor monitoring isn’t permitted would undermine the multifaceted checks designed to safeguard the trial.