Who has primary responsibility for subject safety in a trial?

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

Answer: (D)

The person with primary responsibility for subject safety in a trial is the Principal Investigator. The PI is accountable for the conduct of the study at the site and must actively oversee participant safety, including ongoing monitoring, implementing safety measures, promptly reporting adverse events to the sponsor and regulatory bodies, and ensuring that informed consent is properly obtained and maintained throughout the trial.

The IRB (ethics board) provides protection by reviewing and approving the protocol and consent forms and by conducting continuing safety oversight, but it does not handle the daily safety management of individual participants. The sponsor develops the overall safety monitoring framework and provides safety data, while a Clinical Research Coordinator supports safety reporting and data collection, but primary accountability for subject safety rests with the PI.