What criteria should be considered when selecting auditors for clinical trials?

• A. The auditors' preferred vacation time and location.
• B. Auditors should be independent of the trial processes and qualified by training and experience.
• C. Auditors must be employees of the sponsor.
• D. The auditors' familiarity with the sponsor's competitors.

Answer: (B)

Auditors must be independent from the trial activities and properly qualified to perform the audit. Independence ensures the assessment isn’t biased by involvement in the study, which lets findings reflect true compliance with the protocol, ICH GCP guidelines, and applicable regulations. Qualification means the auditor has undergone appropriate training in GCP, regulatory requirements, and auditing techniques, plus enough experience to correctly review trial documentation, processes, and facilities and to identify deviations and risks.

Other options would compromise impartiality or relevance: personal preferences don’t reflect competence, being a sponsor employee can create a conflict of interest, and familiarity with competitors does not pertain to audit capability.