By name: "KSB-D15-K0009" description: "Genomic and Biomarker Databases: Knowledge of genetic and biomarker repositories that inform personalized medicine approaches to phar..." version: "1.0.0" domain: "D15" domain_name: "Sources of Information" type: "Knowledge" proficiency_level: "L4" bloom_level: "evaluate" triggers: - "explain genomic and biomarker databases" - "what is genomic and biomarker databases" - "evaluate genomic and biomarker databases" epa_mapping: "EPA-02, EPA-04" cpa_mapping: "CPA-05, CPA-07" regulatory_refs: "ICH-E2D Sec 3.2, MULTI-LIT-001"
KSB-D15-K0009: Genomic and Biomarker Databases
Overview
Domain: D15 - Sources of Information Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Evaluate
Description
Knowledge of genetic and biomarker repositories that inform personalized medicine approaches to pharmacovigilance, including population genetics databases, pharmacogenomic resources, and biomarker registries relevant to drug safety assessment.
Context
- Major Section: Core Knowledge
- Section: Emerging Digital Information Sources
EPA Mapping
- EPA-02:3004-3005
- EPA-04:3009-3010
CPA Pathway
- CPA-05, CPA-07
Regulatory References
- ICH-E2D Sec 3.2
- MULTI-LIT-001
Instructions
When this skill is activated, Claude should:
- Demonstrate L4 proficiency in genomic and biomarker databases
- Apply evaluate level cognitive skills to evaluate the topic
- Reference relevant regulatory guidance (ICH-E2D Sec 3.2, MULTI-LIT-001)
- Connect to related EPAs: EPA-02, EPA-04
Key Competencies
- Knowledge of genetic and biomarker repositories that inform personalized medicine approaches to pharmacovigilance, including population genetics databases, pharmacogenomic resources, and biomarker registries relevant to drug safety assessment.
Assessment Criteria
- Can evaluate core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D15 skills in Emerging Digital Information Sources
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31