Which role is designated and supervised by the investigator at the trial site to perform critical trial-related procedures?

• A. Sponsor
• B. Subinvestigator
• C. Trial Site Coordinator
• D. Subject/Trial Subject

Answer: (B)

The idea being tested is how trial tasks are assigned at a site and kept under control. In ICH GCP, a subinvestigator is someone designated by the investigator to perform critical trial-related procedures and who operates under the investigator’s supervision. This arrangement lets qualified team members carry out important protocol tasks while the investigator remains responsible for the trial’s conduct, safety, and integrity. The sponsor is the external organization funding and coordinating the trial, not a person designated at the site to perform procedures. A trial site coordinator is a support staff member who helps with operations and may handle some tasks, but the formal role defined for performing critical procedures under supervision is the subinvestigator. The subject is the participant, not someone who conducts procedures. So the role that fits “designated and supervised by the investigator at the trial site to perform critical trial-related procedures” is the subinvestigator.