Which term describes an individual responsible for the conduct of the clinical trial at a site?

• A. Monitoring
• B. IRB
• C. Investigator
• D. Legally Acceptable Representative

Answer: (C)

The person responsible for conducting the trial at a site is the investigator. In clinical research, the investigator is accountable for running the study according to the protocol, ensuring participant welfare, and maintaining accurate records. This role includes obtaining informed consent, supervising trial procedures, monitoring safety, and ensuring data are collected and reported properly. The investigator may delegate tasks to qualified staff, but ultimate responsibility rests with the investigator (often the Principal Investigator at a site).

These other terms refer to different concepts: Monitoring is a function that oversees data quality and protocol compliance, typically performed by a monitor rather than by the person conducting the trial at the site. The IRB (institutional review board) is the ethics committee that reviews and approves the study to protect participants’ rights and safety. A Legally Authorized Representative is someone who can consent on behalf of a participant who cannot consent for themselves, not the person who conducts the trial at the site.