By name: "KSB-D04-K0029" description: "Assessment Documentation: Causality rationale, expectedness justification, seriousness determination..." version: "1.0.0" domain: "D04" domain_name: "Individual Case Safety Reports" type: "Knowledge" proficiency_level: "L3" bloom_level: "apply" triggers: - "explain assessment documentation" - "what is assessment documentation" - "apply assessment documentation" epa_mapping: "EPA-01, EPA-04, EPA-09" cpa_mapping: "CPA-01, CPA-04" regulatory_refs: "ICH-M1 (MedDRA), ICH-E2B(R3)"
KSB-D04-K0029: Assessment Documentation
Overview
Domain: D04 - Individual Case Safety Reports Type: Knowledge Proficiency Level: L3 (Competent - Minimal supervision) Bloom Level: Apply
Description
Causality rationale, expectedness justification, seriousness determination
Context
- Major Section: Global Regulatory Requirements for ICSRs
- Section: Narrative Development and Documentation
EPA Mapping
- EPA-01:3001-3003
- EPA-04:3009-3010
- EPA-09:3020-3022
CPA Pathway
- CPA-01, CPA-04
Regulatory References
- ICH-M1 (MedDRA)
- ICH-E2B(R3)
Instructions
When this skill is activated, Claude should:
- Demonstrate L3 proficiency in assessment documentation
- Apply apply level cognitive skills to apply the topic
- Reference relevant regulatory guidance (ICH-M1 (MedDRA), ICH-E2B(R3))
- Connect to related EPAs: EPA-01, EPA-04, EPA-09
Key Competencies
- Causality rationale, expectedness justification, seriousness determination
Assessment Criteria
- Can apply core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D04 skills in Narrative Development and Documentation
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31