Which role is an individual who both initiates and conducts a trial and under whose immediate direction the investigational product is administered to a subject?

• A. Sponsor
• B. Sponsor-Investigator
• C. Subinvestigator
• D. Trial Site

Answer: (B)

The situation describes someone who both initiates and conducts the trial and directly oversees the administration of the investigational product to subjects. In GCP terms, this is a sponsor-investigator—the person who takes on the sponsor responsibilities (initiating, managing, financing, and regulatory duties) while also acting as the investigator at the site and directly administering the IP under their supervision. A sponsor is the entity funding and managing the study but not typically the person at the site administering the IP. A subinvestigator assists the investigator but doesn’t carry the primary responsibility for administering the IP. The trial site is the location, not a person. So this role best fits the sponsor-investigator.