Who is responsible for retaining trial-related essential documents until the sponsor informs they are no longer needed?

• A. Investigator/Institution
• B. Sponsor
• C. Regulatory Authority
• D. IRB

Answer: (A)

The main idea is that essential trial documents must remain available where the trial was conducted so the study can be reconstructed and inspected. At the site, the investigator and their institution carry the duty to retain these trial-related essential documents, and they keep them until the sponsor tells them they are no longer needed. This ensures documents like the protocol, amendments, informed consent, IRB approvals, and monitoring reports are accessible for audits or inspections even after the study ends. The sponsor oversees the overall documentation and archive plan, but the site’s responsibility to hold onto the records persists until the sponsor’s directive to dispose of them. Retention periods are also guided by regulatory requirements, and once those periods and the sponsor’s notice align, the documents can be archived or disposed of according to the agreed plan.