Who should retain essential records and for how long?

• A. Only sponsors.
• B. Only investigators.
• C. Sponsors and investigators.
• D. A third-party archive service.

Answer: (C)

Retention of essential records is a shared responsibility of both the sponsor and the investigator. These core documents must be kept securely, accurately, and accessible for inspections and regulatory review throughout the required period. Both parties are expected to maintain their copies or ensure access to the essential records, since verification of the trial and protection of participant rights depend on having complete documentation available. The retention period is not assigned to just one party; it is typically at least 2 years after the last regulatory approval of the investigational product in an ICH region, or longer if required by local regulations or awaiting regulatory actions. Using a third‑party archive can be appropriate, but the ultimate responsibility for retaining and providing access to the records rests with both sponsor and investigator.