Who is the person responsible for the conduct of the clinical trial at a trial site?

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

Answer: (A)

The investigator is the person responsible for conducting the trial at the site. This role includes executing the protocol, ensuring participant safety and rights, obtaining informed consent, determining eligibility, administering the study interventions, and collecting and recording data in accordance with GCP and regulatory requirements. The sponsor oversees the overall study, and the IRB/ethics committee provides protections for participants, but they do not conduct the day-to-day trial at the site. A legally acceptable representative may act in specific situations, but the primary responsibility for site conduct rests with the investigator. Monitoring is a separate activity to verify compliance and data quality, not the person running the trial at the site.