Which bodies may perform inspections of trial data and sites as part of QA activities?

• A. Domestic regulatory authorities only
• B. The sponsor and IRB/IEC
• C. Domestic and foreign regulatory authorities
• D. External auditors appointed by the sponsor

Answer: (C)

Inspections of trial data and sites in QA come from regulatory authorities that have the legal authority to enforce GCP and other regulatory requirements. These bodies can review records, data handling, source documents, consent processes, and site facilities to verify compliance and protect participant safety and data integrity. In multinational trials, inspectors from the country where the trial is conducted and from other participating countries may perform these inspections to ensure consistent standards across all sites. While the sponsor may conduct internal QA audits and external auditors may audit sponsor systems, they do not have the same regulatory authority as authorities, and their inspections aren’t regulatory inspections. Thus, inspections by domestic and foreign regulatory authorities are the applicable QA inspections.