What is required for computerized systems used in clinical trials?

• A. They should be used without validation.
• B. They should be maintained by vendors only.
• C. They should be fit for purpose, with critical quality factors addressed in their design.
• D. They should be optional for sponsors.

Answer: (C)

Computerized systems used in clinical trials must be fit for purpose and designed with critical quality factors in mind. This means the system is validated to ensure it consistently produces accurate, reliable data and maintains data integrity throughout the trial, covering how data is captured, processed, stored, and accessed. A fit-for-purpose system requires a documented development and validation process and a risk-based approach to identify and address potential issues, including proper controls like secure access, audit trails, data security, and reliable backup/recovery. The sponsor (or the organization conducting the trial) holds responsibility for validating and maintaining the system and ensuring it meets requirements, with vendor support as appropriate, rather than relying on validation or maintenance by the vendor alone or treating validation as optional.