What qualifications should persons or parties have when delegated trial-related activities?

• A. They should have prior trial leadership experience only.
• B. They should be appropriately qualified and adequately informed about relevant aspects of the protocol, investigational product(s), and their assigned trial activities.
• C. No special qualifications are required.
• D. Only physicians are eligible.

Answer: (C)

The key idea is that people performing trial-related tasks must be properly qualified. They should have the right education, training, and experience, and they need to be adequately informed about the protocol, the investigational product, and the specific activities they’re assigned. This ensures tasks are done correctly, data are reliable, and participant safety is protected. The investigator remains responsible for the trial and must ensure proper supervision, training, and documentation for those to whom duties are delegated. Qualifications aren’t limited to leadership experience, nor to physicians alone, and there is no requirement that no special qualifications are needed. Anyone carrying out trial activities should have the competence and knowledge to perform them per the protocol and regulatory expectations.