Adverse Event Case Narratives & Causality Assessment
Generate audit-ready adverse event narratives with ICH-GCP causality assessment
What You Can Do
You can rapidly document adverse events with rigorous causality assessment, ensuring consistent safety reporting across sites and phases. The skill guides you through seriousness evaluation, temporal relationship analysis, and evidence-based narrative writing that satisfies regulatory audits and eCTD submission requirements. You'll generate safety documentation that protects trial integrity while accelerating your safety monitoring workflow.
Features
Categorize events by seriousness, expectedness, and temporal relationship to study drug or protocol procedures
Apply WHO-UMC, ICH E2A, or sponsor-specific algorithms consistently across all case narratives
Draft audit-ready case summaries using ICH/FDA terminology and formatting for eCTD submissions
Identify patterns across multiple events or sites that warrant escalation or expedited reporting
Prepare expedited safety reports with 24-48 hour turnaround for critical events
Resolve conflicts between investigator causality judgments and medical/scientific evidence
Validate AE narratives against audit standards before submission to regulatory bodies
Adapt causality logic and reporting format to phase-specific regulatory expectations
Example Output
Example 1: Grade 3 Hypertension – Suspected Related
Adverse Event: Hypertension (Grade 3, Serious, Unexpected)
Case Narrative: Patient XYZ, 58M, enrolled Day 1 on Study ABC-001, Test Drug 100mg BID. Baseline BP 135/82 mmHg. On Study Day 14, patient reported headache and dizziness at clinic visit; BP measured 178/105 mmHg. No prior hypertension history. Temporal relationship strong (13 days post-initiation). ECG normal, urinalysis negative. Investigator assessed "Probably Related." ASSESSMENT: Consistent with known pharmacology of test drug (α-adrenergic effects). WHO-UMC classification: Probable. Recommendation: Continue with antihypertensive co-medication per protocol, intensify BP monitoring.
Example 2: Hospitalization for Gastroenteritis – Unrelated
Adverse Event: Gastroenteritis with dehydration (Grade 3, Serious, Expected)
Case Narrative: Patient ABC, 42F, enrolled Day 8 on Study XYZ-202, Placebo arm. On Study Day 26, presented to hospital ED with 2-day history of diarrhea/vomiting. Stool culture positive for Salmonella (source: contaminated food at family gathering Day 23, before symptom onset). Received IV fluids, discharged Day 27. Test drug exposure: none (placebo). ASSESSMENT: Clear epidemiological link to foodborne pathogen; temporal relationship inconsistent with study drug (patient in placebo arm). WHO-UMC classification: Unrelated. No further action required beyond routine safety reporting.
What's Included
- SKILL.md instruction file with causality frameworks (WHO-UMC, ICH E2A) and regulatory compliance checklists:
- AE Intake Template: Structured form capturing demographics, event details, and temporal relationship
- Causality Assessment Worksheet: Step-by-step algorithm to guide sponsor/investigator causality determination
- Case Narrative Template: Regulatory-compliant structure for serious/unexpected/expedited reports
- Safety Signal Detection Checklist: Pattern recognition matrix for multi-site events requiring escalation
- eCTD Safety Update Format Guide: Formatting rules for FDA/EMA submissions
Who It's For
- Clinical Research Associates (CRAs) — Primary users conducting site monitoring and AE assessment
- Clinical Trial Coordinators — Document safety events and maintain eCTD packages
- Medical Safety Officers — Review investigator assessments and validate causality determinations
- Regulatory Affairs Specialists — Format AE narratives for eCTD submissions and agency submissions
- Pharmacovigilance Managers — Identify safety signals and escalate serious/unexpected events
Best For
- Documenting serious adverse events in Phase I-III trials with consistent causality logic
- Reconciling conflicting investigator assessments with scientific evidence
- Preparing expedited safety reports (24-48 hour turnaround) for regulatory notification
- Conducting pre-audit AE documentation reviews and completeness validation
- Escalating safety signals from pattern recognition across multiple sites or cohorts
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