Tag: serious adverse events

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

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

Learn the clear, legal criteria for when to report serious vs non-serious adverse events in clinical trials. Understand the 6 key outcomes that define seriousness, avoid common reporting mistakes, and know the exact timelines for FDA and IRB submissions.

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