What should the investigator/institution ensure regarding medical care for trial participants during and after the study?

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The central idea is that participant safety requires active responsibility for medical care related to the trial. The investigator/institution must ensure that any adverse events are managed with adequate medical care, and they must inform participants about what care is needed and how to obtain it, both during the trial and after it ends. This includes arranging timely evaluation, treatment, and appropriate follow-up, and providing clear guidance on post-trial medical needs or referrals. The sponsor may supply resources or cover costs, but the obligation to ensure access to appropriate medical care rests with the investigator/institution. Saying that the sponsor provides all care directly, telling participants to seek care on their own, or placing all care responsibilities on the participant ignores the duty to protect participants and coordinate necessary care.