| 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
Regulatory References
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
