Which statement about auditors is correct?

• A. Auditors must be employees of the sponsor
• B. Auditors do not require training or experience
• C. The sponsor should appoint auditors who are independent of the clinical trials and qualified by training and experience
• D. Auditors can be selected from among trial participants

Answer: (C)

Auditing in GCP relies on independence and qualified expertise. The sponsor should appoint auditors who are independent of the clinical trials and trained and experienced in GCP and auditing. Independence ensures objectivity, so findings reflect true compliance rather than any stake in trial outcomes. Qualified auditors have the knowledge to assess protocols, consent processes, data handling, safety reporting, and regulatory requirements, and to identify deviations and root causes.

Auditors can be internal QA staff or external contractors, but they must not be involved in conducting the trial and must have demonstrated training and experience. This is why the idea that auditors must be sponsor employees, or that they don’t require training or experience, or that they can be trial participants, does not fit.