The CDE (NMPA) has released draft guidelines outlining requirements for the use of computerized systems and electronic data in drug clinical trials, focusing on data integrity, validation, and secure management throughout the trial lifecycle.
Key Highlights:
- Public comments open until 24-Dec-2025
- Draft developed through expert seminars and multi-round technical discussions
- Guideline structured into five parts covering system standards, electronic data management, and lifecycle controls
- Emphasizes ALCOA++ principles for data collection and controlled access
- Requires logical verification, traceable data entry checks, and secure electronic signatures
- Certified copies may replace originals if integrity is verified
- Mandates system validation, security controls, and trained personnel
- Data migration procedures must safeguard integrity and include risk assessments
- Audit trails and metadata reviews required to ensure traceability and reliability
Select Mandate HA
Select Mandate Function