ksb-d15-k0009

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:

1. Demonstrate L4 proficiency in genomic and biomarker databases
2. Apply evaluate level cognitive skills to evaluate the topic
3. Reference relevant regulatory guidance (ICH-E2D Sec 3.2, MULTI-LIT-001)
4. 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

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Generated from PV KSB Framework v1.0 | 2025-12-31