What is the primary purpose of an audit in clinical trials?

• A. To speed up publication in journals.
• B. To ensure compliance with regulatory requirements and to assess the quality of the trial.
• C. To reward investigators with bonuses.
• D. To audit only financial records.

Answer: (B)

Audits in clinical trials are independent checks designed to verify that the trial is conducted, recorded, and reported in accordance with the protocol, Good Practice guidelines, and regulatory requirements. The main aim is to assess the quality and integrity of the trial data and to protect the rights and safety of participants. An audit looks across the study process—checking that procedures were followed, source data aligns with the reports, informed consent was properly obtained, adverse events are reported appropriately, and that training, SOPs, data management, and trial systems are in place and functioning. The outcome is to identify deviations or risks and to drive corrective actions and improvements, not to speed publication, reward investigators, or focus only on financial records, since audits cover broader compliance and data integrity.