What is an audit in clinical research?

• A. An independent examination to assess compliance with GCP and regulatory requirements.
• B. A routine internal review conducted by the trial sponsor only.
• C. A public peer-reviewed evaluation of the trial protocol.
• D. A financial audit of the trial's budget.

Answer: (A)

An audit in clinical research is an independent, objective examination of trial activities, records, and processes to confirm they are in compliance with the protocol, Good Clinical Practice (GCP), and applicable regulatory requirements. It is typically conducted by personnel not part of the day-to-day trial team—often a sponsor’s quality assurance unit or regulatory authorities—to assess data integrity, participant protection, proper informed consent, adverse event reporting, and adherence to study procedures. This differs from routine sponsor monitoring or internal reviews, which may lack independence and focus on ongoing oversight; it is not a peer-reviewed evaluation of the protocol, nor is it a financial audit focused on budgeting. The aim is to identify deviations, ensure corrective actions, and uphold trial quality and participant safety.