The responsibility for medical care and medical decisions for trial subjects rests with which professional?

• A. The medical care and decisions are the responsibility of a qualified physician or, when appropriate, a qualified dentist.
• B. The sponsor's medical director is solely responsible.
• C. The trial subject's personal physician is always responsible.
• D. The study team as a whole is responsible.

Answer: (A)

In medical trials, the person who makes and oversees medical care for participants must be a qualified medical professional with the authority to address trial-related health issues. This is typically the investigator, who is a physician, and if the protocol involves dental aspects, a qualified dentist may take on that role. The sponsor provides the protocol and safety oversight, but does not carry out the day-to-day medical decisions for each subject. The subject’s personal physician may be involved for routine health care, but the trial-related medical decisions are not assumed by them automatically. The study team as a whole cannot substitute for the specialized medical judgment required for participant safety.