Ksb D15 K0006

---
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"
---

# 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*