domains / families / science / adverse-event-narrative

adverse-event-narrative

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Generates CIOMS I-compliant ICSR narratives from adverse event case data for FDA and EMA regulatory submission. Includes temporal analysis, MedDRA coding, causality assessment using WHO-UMC or Naranjo criteria, and multi-format output.

When to use

• Use this skill when writing adverse event narratives for regulatory submission (FDA, EMA, CIOMS I).
• Use this skill when preparing ICSR reports or generating safety narratives with MedDRA coding and causality assessment.
• Use this skill when the user says "AE narrative", "ICSR", "CIOMS narrative", "safety report", or "MedWatch narrative".

When not to use

• **Medical Review Required**: Generates draft only; requires physician review before submission
• **Causality Assessment**: Structures reporter's assessment; does not perform independent causality evaluation
• **MedDRA Version**: Uses installed MedDRA version; may not have latest terms
• **Language**: Optimized for English; other languages may need translation
• **Literature Integration**: Does not automatically search literature for similar cases
• **Signal Detection**: Individual case narratives only; aggregate analysis requires other tools
• **Legal Proceedings**: Not suitable for litigation support or expert witness reports

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