FDU-INS 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:
- Demonstrate L1 proficiency in real-world data sources
- Apply understand level cognitive skills to explain 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 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
Generated from PV KSB Framework v1.0 | 2025-12-31