To document that compensation to subjects for trial-related injury will be available, which locations are listed for documentation?

• A. Investigator/Institution
• B. Sponsor
• C. Both Investigator/Institution and Sponsor
• D. Regulatory Authorities

Answer: (C)

In GCP, the plan for compensating trial-related injuries must be documented in two places: at the Investigator/Institution and with the Sponsor. This dual documentation ensures the participant is informed about compensation before enrolling, and that both the site and the sponsor have verifiable records of the commitment. The informed consent form should state that compensation is available, and the sponsor should keep evidence of the coverage or insurance. Having documentation in both locations provides clear accountability and a ready path for claims; relying on a single location could create gaps in how compensation is accessed or verified.