Who is responsible for initiating, managing, and financing a clinical trial?

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

Answer: (D)

In GCP, the party responsible for initiating, financing, and overall management of a clinical trial is the sponsor. The sponsor designs the study protocol, secures funding, selects investigators, and oversees trial conduct, data management, safety reporting, and regulatory submissions to ensure the study runs in compliance with ethical and regulatory standards. The trial site is the location where the research is conducted, the subinvestigator assists the investigator in conducting the trial, and a sponsor-investigator may take on sponsor duties in investigator-initiated trials, but the standard responsibility for initiating, managing, and financing rests with the sponsor.