By name: "KSB-D02-K0012" description: "Causality Assessment Methods: WHO-UMC, Naranjo, Bradford-Hill criteria..." version: "1.0.0" domain: "D02" domain_name: "Clinical Aspects of ADRs" type: "Knowledge" proficiency_level: "L1" bloom_level: "understand" triggers: - "explain causality assessment methods" - "what is causality assessment methods" - "explain causality assessment methods" epa_mapping: "EPA-01, EPA-02, EPA-05" cpa_mapping: "CPA-01, CPA-02" regulatory_refs: "ICH-E2A, FDA-GUID-001"
KSB-D02-K0012: Causality Assessment Methods
Overview
Domain: D02 - Clinical Aspects of ADRs Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand
Description
WHO-UMC, Naranjo, Bradford-Hill criteria
Context
- Major Section: ADR Classification Systems
- Section: Clinical Assessment Frameworks
EPA Mapping
- EPA-01:3001-3003
- EPA-02:3004-3005
- EPA-05:3011-3012
CPA Pathway
- CPA-01, CPA-02
Regulatory References
- ICH-E2A
- FDA-GUID-001
Instructions
When this skill is activated, Claude should:
- Demonstrate L1 proficiency in causality assessment methods
- Apply understand level cognitive skills to explain the topic
- Reference relevant regulatory guidance (ICH-E2A, FDA-GUID-001)
- Connect to related EPAs: EPA-01, EPA-02, EPA-05
Key Competencies
- WHO-UMC, Naranjo, Bradford-Hill criteria
Assessment Criteria
- Can explain core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D02 skills in Clinical Assessment Frameworks
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31