An audit is best described as which of the following?

• A. Sponsor-initiated quality review
• B. External regulatory requirement
• C. Routine equipment maintenance
• D. Participant consent check

Answer: (A)

An audit is sponsor-initiated quality review of trial activities and records to verify compliance with the protocol, SOPs, GCP, and regulatory requirements, and to assess data accuracy and integrity. It’s a formal, independent examination, usually planned and documented, aimed at identifying gaps and ensuring corrective actions. This is different from routine monitoring, which is ongoing oversight of trial conduct; audits provide a broader, deeper assessment of quality systems and compliance across sites. It’s also distinct from an external regulatory requirement, which refers to inspections by regulators rather than sponsor-initiated checks. And it’s not routine equipment maintenance, which is about keeping devices functioning, nor a simple participant consent check, which is just one ethical task within the broader quality review.