Which statement best describes the sponsor's duty regarding costs of treatment for trial-related injuries?

Which statement best describes the sponsor's duty regarding costs of treatment for trial-related injuries?

• A. Investigator salaries during the trial
• B. The sponsor's policies and procedures should address the costs of treatment of trial subjects in the event of trial-related injuries
• C. Marketing expenses for the trial
• D. The travel expenses of subjects

Answer: (B)

The key idea is that sponsors must have a defined plan to cover the costs of medical treatment for any injuries that are related to the trial. In ICH GCP, protecting the safety and welfare of trial subjects includes ensuring that medical care for trial-related injuries is paid for, and this responsibility should be documented in the sponsor’s policies and procedures so there’s a clear process for funding and arranging treatment. That’s why the statement about the sponsor’s policies and procedures addressing these costs is the best choice. The other options don’t address treatment costs for trial-related injuries and are not about the sponsor’s obligation to fund medical care.

The key idea is that sponsors must have a defined plan to cover the costs of medical treatment for any injuries that are related to the trial. In ICH GCP, protecting the safety and welfare of trial subjects includes ensuring that medical care for trial-related injuries is paid for, and this responsibility should be documented in the sponsor’s policies and procedures so there’s a clear process for funding and arranging treatment. That’s why the statement about the sponsor’s policies and procedures addressing these costs is the best choice. The other options don’t address treatment costs for trial-related injuries and are not about the sponsor’s obligation to fund medical care.