ksb-d09-k0006

name: "KSB-D09-K0006" description: "Electronic Health Record Utilization: EMR data extraction and validation, natural language processing for outcome identification, missing ..." version: "1.0.0" domain: "D09" domain_name: "Post-Authorization Studies" type: "Knowledge" proficiency_level: "L1" bloom_level: "understand" triggers: - "explain electronic health record utilization" - "what is electronic health record utilization" - "explain electronic health record utilization" epa_mapping: "EPA-02, EPA-04, EPA-05" cpa_mapping: "CPA-02, CPA-07" regulatory_refs: "FDA-STAT-001, FDA-CFR-006, EMA-GVP-009"

KSB-D09-K0006: Electronic Health Record Utilization

Overview

Domain: D09 - Post-Authorization Studies Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand

Description

EMR data extraction and validation, natural language processing for outcome identification, missing data handling strategies

Context

• Major Section: Post-Authorization Study Design Framework and Methodological Foundation
• Section: Real-World Evidence Framework and Data Source Integration

EPA Mapping

• EPA-02:3004-3005
• EPA-04:3009-3010
• EPA-05:3011-3012

CPA Pathway

• CPA-02, CPA-07

Regulatory References

• FDA-STAT-001
• FDA-CFR-006
• EMA-GVP-009

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in electronic health record utilization
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (FDA-STAT-001, FDA-CFR-006, EMA-GVP-009)
4. Connect to related EPAs: EPA-02, EPA-04, EPA-05

Key Competencies

• EMR data extraction and validation, natural language processing for outcome identification, missing data handling strategies

Assessment Criteria

• Can explain core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D09 skills in Real-World Evidence Framework and Data Source Integration
• Cross-domain integrations per DAG architecture

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