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
You might also like
You can submit tool designs—drawings, specifications, or descriptions—and Claude will evaluate manufacturability constraints, identify potential failure modes using structured frameworks, and recommend cost-reduction opportunities. You'll receive a prioritized report covering structural analysis, production feasibility, material efficiency, and design trade-offs.
by kody-w
You can take unstructured monitoring visit observations and convert them into formal, audit-ready reports that categorize findings by risk level (Critical, Major, Minor), validate protocol compliance, and generate actionable follow-up items with assigned owners and resolution dates. The skill ensures your documentation meets FDA inspection standards and ICH-GCP requirements while creating clear escalation pathways for high-risk issues.
by kody-w
You can automate the validation of clinical trial data against protocol specifications, identify discrepancies including missing values, out-of-range results, protocol violations, and CRF inconsistencies. The skill generates audit-ready query documentation, categorizes anomalies by severity and type, resolves root causes systematically, and produces FDA inspection-ready reports that trace every data decision and corrective action for CDISC and regulatory submission.
by kody-w
You can submit raw mass spectrometry observations, instrument parameters, or sample preparation details to Claude and receive targeted diagnostic frameworks that explain anomalous results. Claude systematically generates plausible mechanistic explanations for unexpected protein abundance patterns, quantification inconsistencies, and PTM findings—then helps you design minimal, hypothesis-driven troubleshooting experiments to test them.
by kody-w
You can validate eCRF and paper CRF datasets against protocol-defined rules, automatically identify data discrepancies (missing fields, out-of-range values, date inconsistencies), generate structured Data Query Forms (DQFs) for site clarification, track resolution status, and create audit-ready compliance documentation that meets FDA 21 CFR Part 11 and GCP requirements. This workflow reduces manual validation time while ensuring 100% traceability and regulatory readiness for inspections.
by kody-w
Get comprehensive PCB design analysis covering power delivery networks, signal integrity, thermal management, and manufacturing constraints. Claude identifies potential issues early and provides specific, actionable optimization recommendations to reduce cost, improve reliability, and accelerate time-to-market. Suitable for designs from initial concept through production-ready layouts.
by kody-w
You consolidate parallel data streams from preclinical toxicology studies (clinical pathology, histopathology, body weight changes, organ weights, clinical observations, mortality) into coherent regulatory-compliant narratives. This skill synthesizes findings across 6–12 endpoints simultaneously, identifies NOAEL/LOAEL with biological justification, determines safety margins, interprets species-specific or sex-specific signals, and produces Results & Discussion sections that satisfy FDA/EMA reviewers while supporting appropriate dosing decisions for IND-enabling studies.
by kody-w
This skill systematically analyzes your product designs to identify manufacturability issues early, saving costly revisions and manufacturing delays. It evaluates geometry, material selection, tolerances, assembly feasibility, and production process constraints. You get actionable feedback on cost drivers, process risks, and design optimizations before committing to production.
by kody-w