BytesAgain βΊ Skills βΊ Adverse Event Narrative
π¦ ClawHub
Adverse Event Narrative
by @aipoch-ai
Generate CIOMS-compliant adverse event narratives for Individual Case Safety Reports (ICSR). Creates structured pharmacovigilance documents following CIOMS I...
Versionv0.1.0
β‘ When to Use
| Trigger | Action |
|---|---|
| - Drafting ICSR narratives for regulatory submissions | |
| - Converting safety case data to standardized text | |
| - Preparing adverse event reports for health authorities | |
| - Generating case summaries for signal detection | |
| - Creating pharmacovigilance documentation for clinical trials | |
| - Standardizing narrative format across safety teams | |
| - Training new drug safety associates on narrative writing | |
| **β Do NOT use when:** | |
| - Case requires medical judgment or causality assessment β Use qualified safety physician | |
| - Narrative for litigation or legal proceedings β Use legal documentation standards | |
| - Patient-facing communications β Use `lay-summary-gen` | |
| - Aggregate safety summaries β Use `safety-summary-reports` | |
| - Coding MedDRA terms from verbatim β Use `meddra-coder` | |
| **Integration:** | |
| - **Upstream**: `meddra-coder` (MedDRA term coding), `clinical-data-cleaner` (data preparation) | |
| - **Downstream**: `safety-summary-reports` (aggregate analysis), `regulatory-submission-prep` (FDA/EMA filing) | |
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