GUIDANCE Draft Draft
Guiding Principles for Computerized Systems and Electronic Data in Drug Clinical Trials (Draft for Comment)
ABSTRACT — EDITORS' SUMMARY
China's equivalent of the EMA Computerized Systems Guideline. Covers computerized system validation, electronic data standards, ALCOA principles, and audit trail requirements in clinical trials. Published November 24, 2025 to align with ICH E6(R3) and the NMPA 2020 GCP.
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PDF · CANONICAL LINK https://www.cde.org.cn/main/att/download/1e5bd8845b90ed4203c8973ac4b0b36e ↗ COMPANION DOCUMENTS
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