Who is responsible for trial-related medical care and decisions for participants?

• A. The sponsor's medical department.
• B. A trained nurse.
• C. A qualified physician or qualified healthcare professional who is an investigator or sub-investigator.
• D. The monitoring committee.

Answer: (C)

The person responsible for trial-related medical care and decisions is the on-site medical authority who is a qualified physician or qualified healthcare professional designated as an investigator or sub-investigator. This role has the clinical expertise to assess participant safety, interpret medical events in the context of the protocol, and provide or authorize treatment as required by the study. The sponsor’s medical department provides oversight and support but does not make ongoing medical decisions for participants. A monitoring committee (often called a DSMB) reviews safety data and overall trial conduct, not individual patient care. While a trained nurse may deliver care and monitor participants, the ultimate medical decision-making authority rests with the investigator or sub-investigator who is a qualified physician or healthcare professional.