During and after participation, what is the investigator's obligation regarding adverse events and significant laboratory values?

• A. Medical care is only required during the trial and not after.
• B. Medical care for adverse events is optional.
• C. Adequate medical care should be provided for adverse events and related significant laboratory values during and after participation.
• D. The sponsor is solely responsible for medical care.

Answer: (C)

The key idea is that participant safety drives ongoing medical management for any adverse events and for significant laboratory abnormalities that are related to the trial. The investigator must ensure that adequate medical care is provided or arranged not only during the study but also after participation ends, if follow-up or treatment is needed to ensure the participant’s well-being. This reflects the duty to protect welfare and to ensure proper resolution and monitoring of issues that arise from the trial, even after the subject has left the study. The sponsor has safety responsibilities as well, but the investigator retains the primary obligation to secure appropriate medical care for the participant.