What is an audit?

• A. Sponsor-initiated quality review
• B. Internal financial audit
• C. Laboratory equipment calibration
• D. Participant recruitment activity

Answer: (A)

In clinical research, an audit is a formal, independent examination to verify that a trial is conducted and data are generated in accordance with the protocol, GCP, and applicable regulations, while also protecting participant rights and safety. A sponsor-initiated quality review fits this definition because sponsors are responsible for assuring quality and compliance across the study, and they actively assess how the trial is being conducted to identify and address issues.

Other activities described are not audits in this sense. An internal financial audit focuses on financial records rather than trial conduct or data integrity. Laboratory equipment calibration is a quality control task to ensure accurate measurements, not an evaluation of compliance with the trial protocol and regulations. Participant recruitment activity relates to enrolling participants and is an operational task, not a formal review of overall trial governance and data integrity.