Which documentation should the IRB/IEC consider to assess the investigator's qualifications for a proposed trial?

• A. The protocol and site contract only
• B. Current curriculum vitae and any other relevant documentation the IRB/IEC requests
• C. A personal reference from colleagues
• D. The investigator's medical license alone

Answer: (B)

IRBs assess an investigator’s ability to conduct the study safely and in compliance with GCP, which requires up-to-date evidence of their qualifications. The best documentation to review is the investigator’s current curriculum vitae, along with any other relevant materials the IRB/IEC requests. This collection allows the IRB to verify education, training, clinical and research experience, and the investigator’s demonstrated track record in conducting human subjects research and adhering to regulatory requirements. The protocol and site contract show study design and fiscal terms but do not reveal the investigator’s qualifications. A personal reference can be subjective and incomplete, and a medical license alone demonstrates clinical credentialing but not trial-specific qualifications or GCP competency. Therefore, current CV plus any IRB-requested documents provides the most complete basis to judge whether the investigator is qualified to oversee the proposed trial.