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name: "KSB-D15-K0006" description: "Real-World Data Sources: Knowledge of electronic health records, insurance claims databases, patient registries, and healthca..." version: "1.0.0" domain: "D15" domain_name: "Sources of Information" type: "Knowledge" proficiency_level: "L1" bloom_level: "understand" triggers:

• "explain real-world data sources"
• "what is real-world data sources"
• "explain real-world data sources" epa_mapping: "EPA-02, EPA-04" cpa_mapping: "CPA-05, CPA-07" regulatory_refs: "ICH-E2D Sec 3.2, MULTI-LIT-001"

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KSB-D15-K0006: Real-World Data Sources

Overview

Domain: D15 - Sources of Information Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand

Description

Knowledge of electronic health records, insurance claims databases, patient registries, and healthcare system data repositories, understanding data quality considerations, access mechanisms, privacy requirements, and analytical limitations that influence pharmacovigilance applications.

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 L1 proficiency in real-world data sources
2. Apply understand level cognitive skills to explain 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 electronic health records, insurance claims databases, patient registries, and healthcare system data repositories, understanding data quality considerations, access mechanisms, privacy requirements, and analytical limitations that influence pharmacovigilance applications.

Assessment Criteria

• Can explain 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