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Tag: AE reporting

Serious vs Non-Serious Adverse Events: When to Report in Clinical Trials
serious adverse events non-serious adverse events AE reporting clinical trial safety SAE criteria

Serious vs Non-Serious Adverse Events: When to Report in Clinical Trials

Understand when to report serious vs non-serious adverse events in clinical trials. Learn the FDA and ICH criteria, reporting timelines, common mistakes, and how to avoid over-reporting that slows down safety monitoring.

December 5 2025

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