Which statement best describes sponsor's audit purpose?

• A. To certify the investigator's license
• B. To select sites for future marketing
• C. To evaluate trial conduct and compliance with the protocol, SOPs, GCP, and applicable regulatory requirements
• D. To enforce noncompliance without investigation

Answer: (C)

Sponsor audits are about verifying that a trial is conducted properly and in line with the approved protocol, the sponsor’s standard operating procedures, Good Clinical Practice, and applicable regulations. This ensures that participant safety is protected and the data collected are credible and reliable. During an audit, the sponsor reviews key aspects such as consent processes, eligibility criteria, source data verification, adherence to the protocol and SOPs, adverse event reporting, and product accountability. These checks help identify issues and drive corrective and preventive actions to improve trial quality. It is not about certifying an investigator’s license, selecting sites for marketing, or enforcing noncompliance without investigation—the latter would require formal regulatory steps, whereas audits aim to assess compliance and guide improvements.