Which statement best describes an audit in clinical trials?

• A. It is identical to routine monitoring
• B. It is optional
• C. It is independent of routine monitoring to evaluate conduct and compliance with protocol, SOPs, GCP, and regulatory requirements
• D. It only checks financial records

Answer: (C)

An audit in clinical trials is an independent, objective evaluation of trial activities to determine whether they are conducted and reported in accordance with the protocol, standard operating procedures, Good Clinical Practice, and applicable regulations. It stands apart from routine monitoring, which is ongoing site oversight conducted by sponsors or CROs to protect subjects and ensure data quality. Because an audit is independent, it can assess the overall quality and compliance of the trial processes—beyond day-to-day monitoring—and may review procedures, training, documentation, facilities, and records. Its purpose is to identify gaps and compel corrective actions to improve compliance and trial integrity, not merely to observe routine operations. Audits are a required part of quality assurance and regulatory oversight, not optional, and they cover more than just financial records, encompassing the broader conduct of the trial.