Who may request evidence of the investigator's qualifications?

• A. The sponsor, the IRB/IEC, and/or regulatory authorities
• B. The patients
• C. The hospital staff
• D. The press

Answer: (A)

The main idea is that those who oversee and regulate clinical trials can request proof that an investigator is qualified to conduct the study. The sponsor, the IRB/IEC, and regulatory authorities all have the authority to ask for evidence of the investigator’s qualifications—such as a current CV, licenses, and appropriate training—to confirm they meet the standards needed to protect participants and properly conduct the trial. Patients, hospital staff, and the press do not have a formal role in requesting or verifying these credentials.