Documentation of regulatory authorities' authorization/approvals/notifications required for protocol amendments and other documents should be kept by which parties?

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

Answer: (D)

In GCP practice, regulatory approvals and related amendments are essential documents that both the investigator/institution and the sponsor must keep. The investigator needs to retain the approvals and any regulatory notices at the site to show that the study was conducted with the required permissions and that amendments were implemented with proper authorization. The sponsor, meanwhile, holds the trial’s regulatory master file and must retain copies of these approvals to demonstrate overall compliance, provide access for monitors and inspections, and ensure the trial can be reviewed across all sites. Having documentation in both places supports audit readiness, regulatory inspections, and continuity if one party’s records are reviewed or requested. In practice, the investigator maintains site-specific regulatory documents, while the sponsor maintains the overarching regulatory documentation; both should be able to supply copies as needed and keep them for the required retention period.