By 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:
- Demonstrate L4 proficiency in ai-generated real-world evidence
- Apply analyze level cognitive skills to analyze the topic
- Reference relevant regulatory guidance (general PV standards)
- 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
Generated from PV KSB Framework v1.0 | 2025-12-31