What action ensures compliance with GCP regarding oversight?

• A. Monitoring and auditing by sponsor, and inspection by regulatory authorities
• B. The investigator's personal opt-out
• C. No oversight is required for low-risk trials
• D. Only sponsor oversight is needed

Answer: (A)

Oversight in GCP relies on a system of checks where the sponsor actively monitors and audits the study, and regulatory authorities may inspect to verify adherence to the protocol, GCP, and applicable laws. Regular monitoring helps detect deviations, protect participant safety, ensure data integrity, and confirm proper informed consent. Inspections by regulators provide independent verification and enforcement. The other options miss essential elements: investigators cannot opt out of oversight, oversight is required for trials at all risk levels, and relying only on sponsor oversight omits the necessary independent verification and external checks performed by regulators.