Which information must be provided for the qualified physician or dentist responsible for all trial-site medical decisions if the physician is not the investigator?

• A. Name, title, address, and telephone numbers of the qualified physician or dentist
• B. Protocol version and amendment history
• C. List of investigators involved in the trial
• D. Informed consent templates used at the site

Answer: (A)

The information that must be provided is the name, title, address, and telephone numbers of the qualified physician or dentist responsible for all trial-site medical decisions when that physician is not the investigator. This designation ensures a clear and accessible medical decision-maker is identified, so that medical questions or emergencies can be directed to the person with appropriate qualifications and authority. It supports regulatory oversight and patient safety by guaranteeing there is a readily reachable contact for medical decisions at the site.

While protocol version history, the list of investigators, and the informed consent templates are important for governance and operations, they do not fulfill the requirement to identify and provide contact details for the physician or dentist responsible for medical decisions.