Who may inspect trial records as part of QA and regulatory oversight?

• A. The investigator
• B. The sponsor
• C. The IRB/IEC
• D. Domestic and foreign regulatory authorities

Answer: (D)

Regulatory authorities have the legal authority to inspect trial records to verify compliance with GCP and applicable regulations. This includes both domestic bodies (like the country’s health authority) and foreign authorities that oversee trials conducted in their jurisdictions. They can review source documents, case report forms, consent forms, and the trial master file during inspections to ensure data integrity, protocol adherence, safety reporting, and proper informed consent. While the sponsor, investigator, and IRB/IEC play essential roles in monitoring, ethics review, and safeguarding participants, the actual inspections for QA and regulatory oversight come from these authorities, including those from other countries when applicable.