By name: "KSB-D08-K0023" description: "Signal Validation Automation: Evidence synthesis algorithms, causality assessment support systems, Bradford Hill criteria automate..." version: "1.0.0" domain: "D08" domain_name: "Signal Detection & Management" type: "Knowledge" proficiency_level: "L4" bloom_level: "evaluate" triggers: - "explain signal validation automation" - "what is signal validation automation" - "evaluate signal validation automation" 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-K0023: Signal Validation Automation
Overview
Domain: D08 - Signal Detection & Management Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Evaluate
Description
Evidence synthesis algorithms, causality assessment support systems, Bradford Hill criteria automated evaluation
Context
- Major Section: Multi-Source Data Integration and Intelligence Synthesis
- Section: AI-Enhanced Data Quality and Signal Validation
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 L4 proficiency in signal validation automation
- Apply evaluate level cognitive skills to evaluate 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
- Evidence synthesis algorithms, causality assessment support systems, Bradford Hill criteria automated evaluation
Assessment Criteria
- Can evaluate core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D08 skills in AI-Enhanced Data Quality and Signal Validation
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31