What measures should be taken to ensure the essential records are maintained?

• A. Archive records monthly.
• B. Store records in multiple languages.
• C. Ensure availability, accessibility, readability, and prevent unauthorized access and accidental or premature destruction.
• D. Limit access to the sponsor only.

Answer: (C)

Maintaining essential records means keeping them in a way that they can be retrieved and understood when needed, while staying protected from loss or improper changes. The best approach is to ensure availability, accessibility, readability, and protection against unauthorized access and accidental or premature destruction.

Availability and accessibility mean authorized personnel—such as investigators, monitors, auditors, and sponsors—can locate and retrieve records promptly. Readability ensures records are legible and in a form that can be understood now and in the future, which may involve using validated systems, backups, and clear documentation. Preventing unauthorized access and premature destruction involves implementing appropriate security controls, access restrictions, regular backups, and a documented retention/destruction policy so records aren’t destroyed before their required retention period ends.

While archiving or storing in multiple languages might be useful in some contexts, they don’t by themselves address the core needs of record integrity and retrievability. Limiting access to the sponsor only would impede necessary oversight and monitoring.