Who has overall responsibility for trial conduct at the site?

Who has overall responsibility for trial conduct at the site?

• A. Sponsor
• B. Principal Investigator (PI)
• C. Clinical Research Coordinator (CRC)
• D. IRB

Answer: (B)

The main idea is that the Principal Investigator has the ultimate responsibility for how the trial is conducted at the site. Under GCP, the PI is accountable for the proper conduct of the study at their site, including protocol adherence, protecting participant rights and safety, ensuring informed consent is properly obtained, and keeping accurate, verifiable data. Delegation is allowed to qualified staff like a Clinical Research Coordinator, but the PI remains responsible for those tasks and for overall compliance with the protocol and regulations. The sponsor oversees the trial at a broader level—design, funding, and sponsor-level monitoring—but is not responsible for day-to-day site conduct. The IRB/IEC focuses on participant protection and protocol approval/oversight, not running the site. So, the person with overall responsibility for trial conduct at the site is the Principal Investigator.

The main idea is that the Principal Investigator has the ultimate responsibility for how the trial is conducted at the site. Under GCP, the PI is accountable for the proper conduct of the study at their site, including protocol adherence, protecting participant rights and safety, ensuring informed consent is properly obtained, and keeping accurate, verifiable data. Delegation is allowed to qualified staff like a Clinical Research Coordinator, but the PI remains responsible for those tasks and for overall compliance with the protocol and regulations. The sponsor oversees the trial at a broader level—design, funding, and sponsor-level monitoring—but is not responsible for day-to-day site conduct. The IRB/IEC focuses on participant protection and protocol approval/oversight, not running the site. So, the person with overall responsibility for trial conduct at the site is the Principal Investigator.