Who should provide Curriculum Vitae and other documents evidencing qualifications of investigators and sub-investigators?

• A. Investigator/Institution only
• B. Sponsor only
• C. Both Investigator/Institution and Sponsor
• D. Regulatory Authorities

Answer: (C)

In GCP, showing that investigators and sub-investigators are qualified is a joint obligation of the investigator/institution and the sponsor. The investigator and their institution must provide current CVs and other evidence of qualifications to the sponsor before the trial starts, demonstrating they have the training and expertise to conduct the study. The sponsor then uses these documents to verify qualifications and to maintain the essential documents in the trial master file; they may present them to ethics committees or regulatory authorities if requested. Sub-investigators’ qualifications must be documented in the same way, and the sponsor ensures those documents accompany the trial’s essential documents. Regulatory authorities don’t obtain these directly from investigators; they rely on the sponsor to maintain and provide the records during inspections or submissions.