What term describes the act by a regulatory authority of conducting an official review of documents, facilities, records, and related resources for the trial?

• A. Inspection
• B. Direct Access
• C. Documentation
• D. Institution (Medical)

Answer: (A)

An inspection is the formal, on-site evaluation by a regulatory authority of documents, facilities, records, and related resources involved in a trial. It’s a structured check to confirm that the study is conducted in compliance with GCP and applicable regulations, safeguarding participant rights and ensuring data integrity. During an inspection, inspectors may review the trial master file, informed consent forms, source documents, equipment, and procedures, and may interview staff to verify adherence to the protocol and regulatory requirements. Direct access describes the regulator’s right to view those records and data during such activities, not the act of reviewing itself. Documentation refers to the records being reviewed, and Institution (Medical) denotes a type of entity, not the review process.