What is the primary purpose of a sponsor's audit?

• A. To evaluate the marketing potential of the trial
• B. To evaluate trial conduct and compliance with the protocol, SOPs, GCP, and regulatory requirements
• C. To prepare the final research article
• D. To audit financial transactions unrelated to the trial

Answer: (B)

The primary purpose is to verify that the trial was conducted and documented in accordance with the protocol, standard operating procedures, ICH GCP guidelines, and applicable regulatory requirements, and to ensure the rights, safety, and well-being of participants as well as the integrity of the data. A sponsor’s audit examines how the study was carried out, how records were kept, consent obtained, training completed, and how deviations and CAPAs were managed, so it can identify areas for corrective action and improvements. It is not about evaluating marketing potential, preparing the final research article, or auditing financial transactions unrelated to the trial.