Which parties are responsible for maintaining documentation of regulatory authorities' authorization/approvals/notifications for protocol amendments and other documents?

• A. Investigator/Institution
• B. Both Investigator/Institution and Sponsor
• C. Sponsor
• D. Neither

Answer: (B)

In GCP, keeping up-to-date regulatory documentation is a shared responsibility between the sponsor and the investigator/institution. The sponsor has the overall duty to manage regulatory submissions and maintain the master regulatory documentation that shows authorities have authorized or approved the trial and any protocol amendments. At the same time, the investigator/institution must hold site-specific records showing that the regulatory authorities and ethics committees have granted approvals or provided notifications for the trial, amendments, and other required documents. This ensures that both the overarching regulatory requirements and the on-site approvals are available for inspections and verification. Because protocol amendments often require formal approvals or notifications, both parties must maintain copies of these authorizations and keep their documentation current and accessible.