Can an investigator delegate trial-related activities to other persons or parties, and how is final decision-making affected?

• A. Yes, the investigator may delegate trial-related activities to other persons but retains final decision-making authority.
• B. No, the investigator must perform all trial-related activities personally.
• C. Yes, but only to sponsor staff with formal delegation.
• D. Yes, but only for administrative tasks.

Answer: (A)

In Good Clinical Practice, an investigator may delegate trial-related activities to qualified, trained personnel to ensure efficient and proper conduct of the study. Importantly, while tasks can be assigned to others, the investigator remains responsible for the trial’s conduct, the integrity of the data, and the safety and rights of participants. The final decision-making authority does not transfer with delegation—the investigator must supervise, review, and, when needed, override or direct actions to protect the trial and participants. Delegation should be documented (for example, in a delegation log) and accompanied by appropriate training and supervision.