Who is responsible for the medical care and medical decisions for trial subjects?

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

Answer: (A)

The person responsible for medical care and medical decisions for trial subjects is the investigator, a qualified physician, and, when appropriate for the trial, a qualified dentist. This role carries the clinical authority to diagnose conditions, manage medical issues related to the trial, assess and respond to adverse events, and decide whether to continue, modify, or stop a subject’s participation to protect safety and welfare. The sponsor’s medical director may provide expert oversight and guidance, but does not replace the physician’s direct medical responsibility for each subject. A family physician may be involved or consulted, but is not automatically responsible for the trial’s medical decisions. The study team supports care, yet final medical decisions rest with the investigator.