By name: "KSB-D04-K0016" description: "Source Document Review: Primary information evaluation, quality assessment, completeness verification..." version: "1.0.0" domain: "D04" domain_name: "Individual Case Safety Reports" type: "Knowledge" proficiency_level: "L4" bloom_level: "evaluate" triggers: - "explain source document review" - "what is source document review" - "evaluate source document review" epa_mapping: "EPA-01, EPA-04, EPA-09" cpa_mapping: "CPA-01, CPA-04" regulatory_refs: "ICH-M1 (MedDRA), ICH-E2B(R3)"
KSB-D04-K0016: Source Document Review
Overview
Domain: D04 - Individual Case Safety Reports Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Evaluate
Description
Primary information evaluation, quality assessment, completeness verification
Context
- Major Section: Global Regulatory Requirements for ICSRs
- Section: Case Intake and Initial Assessment
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 L4 proficiency in source document review
- Apply evaluate level cognitive skills to evaluate the topic
- Reference relevant regulatory guidance (ICH-M1 (MedDRA), ICH-E2B(R3))
- Connect to related EPAs: EPA-01, EPA-04, EPA-09
Key Competencies
- Primary information evaluation, quality assessment, completeness verification
Assessment Criteria
- Can evaluate core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D04 skills in Case Intake and Initial Assessment
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31