Adverse Event Narrative Generator

Overview

Regulatory-grade narrative generation tool that transforms adverse event case data into CIOMS-compliant ICSR narratives suitable for submission to FDA, EMA, and other health authorities.

Key Capabilities:

• CIOMS I Compliance: Standardized narrative structure per international guidelines
• ICH E2B Integration: Electronic submission format compatibility
• Temporal Analysis: Timeline reconstruction and causality assessment
• Medical Accuracy: Clinical terminology and MedDRA coding
• Multi-Case Processing: Batch narrative generation for periodic reporting
• Quality Validation: Automated checks for completeness and consistency

When to Use

✅ Use this skill when:

• 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

❌ Do NOT use when:

• Case requires medical judgment or causality assessment → Use qualified safety physician
• Narrative for litigation or legal proceedings → Use legal documentation standards
• Patient-facing communications → Use lay-summary-gen
• Aggregate safety summaries → Use safety-summary-reports
• Coding MedDRA terms from verbatim → 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)

Core Capabilities

1. CIOMS I Narrative Structure

Generate standardized sections per CIOMS guidelines:

from scripts.narrative_generator import NarrativeGenerator

generator = NarrativeGenerator()

# Generate complete narrative
narrative = generator.generate(
    case_data=case_json,
    format="cioms_i",  # or "ich_e2b", "fda_medwatch"
    include_meddra=True
)

narrative.save("ICSR_2024_001_narrative.txt")

Standard Sections:

1. Patient Demographics - Age, sex, weight, relevant characteristics
2. Medical History - Significant pre-existing conditions
3. Concomitant Medications - Other drugs at time of event
4. Suspect Drug(s) - Medication(s) in question with dosing
5. Adverse Event - Detailed reaction description with MedDRA terms
6. Diagnostic Results - Lab values, imaging, procedures
7. Treatment - Medical management of the event
8. Dechallenge/Rechallenge - Effect of drug withdrawal/reintroduction
9. Outcome - Final patient status and sequelae
10. Causality Assessment - Reporter's relationship evaluation

2. Temporal Relationship Analysis

Reconstruct timeline and assess temporal plausibility: