What is the sponsor's obligation regarding insurance in clinical trials?

• A. Provide comprehensive health insurance to all participants regardless of injury.
• B. Insurance is not required for trials.
• C. Ensure appropriate insurance coverage for trial-related injuries as required by regulations.
• D. The sponsor is responsible for obtaining malpractice insurance only for investigators.

Answer: (C)

The main idea is that the sponsor must arrange for appropriate insurance or indemnification to cover injuries related to the trial, in line with regulatory requirements. This means there should be coverage or a formal arrangement so participants who suffer trial-related injuries can receive medical care and be compensated as required by applicable laws and guidelines. It isn’t about providing comprehensive health insurance to every participant; it isn’t dismissed as optional, and it isn’t limited to malpractice insurance for investigators. The sponsor’s obligation is to ensure there is proper coverage for trial-related injuries as mandated.