By name: "KSB-D08-K0016" description: "Spontaneous Reporting System Analysis: Global database integration (FDA FAERS, EudraVigilance, WHO VigiBase), reporting bias adjustment, du..." version: "1.0.0" domain: "D08" domain_name: "Signal Detection & Management" type: "Knowledge" proficiency_level: "L3" bloom_level: "apply" triggers: - "explain spontaneous reporting system analysis" - "what is spontaneous reporting system analysis" - "apply spontaneous reporting system analysis" epa_mapping: "EPA-04, EPA-05" cpa_mapping: "CPA-02" regulatory_refs: "FDA-GUID-006, EMA-GVP-005, EMA-GVP-010, CIOMS-VIII"
KSB-D08-K0016: Spontaneous Reporting System Analysis
Overview
Domain: D08 - Signal Detection & Management Type: Knowledge Proficiency Level: L3 (Competent - Minimal supervision) Bloom Level: Apply
Description
Global database integration (FDA FAERS, EudraVigilance, WHO VigiBase), reporting bias adjustment, duplicate detection across systems
Context
- Major Section: Multi-Source Data Integration and Intelligence Synthesis
- Section: Comprehensive Data Source Management
EPA Mapping
- EPA-04:3009-3010
- EPA-05:3011-3012
CPA Pathway
- CPA-02
Regulatory References
- FDA-GUID-006
- EMA-GVP-005
- EMA-GVP-010
- CIOMS-VIII
Instructions
When this skill is activated, Claude should:
- Demonstrate L3 proficiency in spontaneous reporting system analysis
- Apply apply level cognitive skills to apply the topic
- Reference relevant regulatory guidance (FDA-GUID-006, EMA-GVP-005, EMA-GVP-010, CIOMS-VIII)
- Connect to related EPAs: EPA-04, EPA-05
Key Competencies
- Global database integration (FDA FAERS, EudraVigilance, WHO VigiBase), reporting bias adjustment, duplicate detection across systems
Assessment Criteria
- Can apply core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D08 skills in Comprehensive Data Source Management
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31