Informing the subject's primary physician about participation is recommended under what condition?

• A. The subject has a primary physician and agrees to being informed.
• B. The subject has a primary physician but does not want to be informed.
• C. The subject has no primary physician.
• D. Informing the primary physician is never recommended.

Answer: (A)

Coordinating a trial participant’s care with their regular healthcare providers is important for safety and continuity of treatment. The best practice is to inform the subject’s primary physician when the subject does have a primary physician and explicitly agrees to being informed about trial participation. This consent ensures the physician can consider trial-related events, medications, and potential reactions in the patient’s overall care, helping to prevent adverse interactions and to manage safety effectively. If the subject does not have a primary physician, or if the subject does not want information shared, then disclosure should not occur. The key point is obtaining the subject’s consent to share information and limiting disclosures to what is necessary for safety and ongoing care.