What should the sponsor provide when regulatory requirements require coverage for trial-related injuries?

• A. Provide insurance or indemnify the investigator/institution against claims arising from the trial (except for claims arising from malpractice or negligence)
• B. Reimburse all medical costs for subjects regardless of injury source
• C. Require subjects to sign waivers releasing the sponsor from liability
• D. Cover only malpractice-related costs

Answer: (A)

The main idea is that the sponsor must provide protection for trial-related injuries through insurance or by indemnifying the investigator and the institution. This ensures there’s a financial mechanism to cover injuries that occur as a result of the trial, protecting both participants and the site conducting the study. The coverage typically excludes only claims arising from the investigator’s own malpractice or negligence, meaning most trial-related injuries are covered regardless of fault.

This aligns with regulatory expectations that sponsors bear responsibility for funding and facilitating compensation for trial-related injuries, so sites can enroll participants without the burden of potential financial loss.

Other options don’t fit because they either promise to reimburse medical costs from any source (too broad and not the sponsor’s typical obligation for trial-related injuries), require subjects to sign waivers releasing the sponsor from liability (not permissible), or cover only malpractice-related costs (omits many injuries tied to the trial).