ksb-d09-k0104

name	KSB-D09-K0104
description	AI-Generated Real-World Evidence: Understanding of AI methodologies for generating real-world evidence including automated cohort iden...
version	1.0.0
domain	D09
domain_name	Post-Authorization Studies
type	Knowledge
proficiency_level	L4
bloom_level	analyze
triggers	["explain ai-generated real-world evidence","what is ai-generated real-world evidence","analyze ai-generated real-world evidence"]
epa_mapping	EPA-02, EPA-04, EPA-05
cpa_mapping	CPA-02, CPA-07
regulatory_refs

KSB-D09-K0104: AI-Generated Real-World Evidence

Overview

Domain: D09 - Post-Authorization Studies Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Analyze

Description

Understanding of AI methodologies for generating real-world evidence including automated cohort identification, machine learning-based confounding adjustment, AI-powered outcome ascertainment, and causal inference applications in observational data.

Context

• Major Section: AI in Post-Authorization Studies
• Section: Real-World AI Evidence

EPA Mapping

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

CPA Pathway

• CPA-02, CPA-07

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in ai-generated real-world evidence
2. Apply analyze level cognitive skills to analyze the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-02, EPA-04, EPA-05

Key Competencies

• Understanding of AI methodologies for generating real-world evidence including automated cohort identification, machine learning-based confounding adjustment, AI-powered outcome ascertainment, and causal inference applications in observational data.

Assessment Criteria

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

Related Skills

• Other D09 skills in Real-World AI Evidence
• Cross-domain integrations per DAG architecture

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