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GUIDANCE Final

Technical Guidelines for Evaluation of the Relevance of Adverse Events in Drug Clinical Trials

No. 31 of 2024 National Medical Products Administration
ABSTRACT — EDITORS' SUMMARY

CDE guidance on evaluating the causal relationship between adverse events and investigational drugs during clinical trials. Maps to E6(R3) §3.13 safety reporting.

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METADATA
TypeGUIDANCE
Year2024
VersionFinal
StatusCurrent
FormatPDF
Pages17
Size6.1 MB
Last reviewedJUN 2024
SOURCE
PDF · CANONICAL LINK https://www.cde.org.cn/main/news/viewInfoCommon/4a223ed70553767e810242f4510da3ac ↗
COMPANION DOCUMENTS
PDF · 4.6 MB ↗
Drafting Explanatory Notes (起草说明)
CDE's drafting commentary — explains scope, intent, and Bradford Hill adaptations behind each section of the guideline.
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