When should the investigator inform the subject about the need for medical care for intercurrent illness(es)?

• A. The investigator should inform the subject only after the trial ends.
• B. The investigator should inform the subject's primary physician but not the subject.
• C. The sponsor should be informed first.
• D. The investigator should inform the subject when medical care is needed for intercurrent illness(es) of which the investigator becomes aware.

Answer: (D)

When an intercurrent illness arises that requires medical care, the investigator should inform the subject promptly. This direct communication protects the subject’s safety, allows timely medical evaluation and treatment, and supports the subject’s right to understand risks and make informed decisions about continuing in the trial. Delaying notification until after the trial ends would compromise safety. Informing only the primary physician or the sponsor first does not place the subject at the center of care and decision-making in the moment when medical needs arise. The investigator’s timely notification to the subject about the need for medical care is the appropriate course.