ksb-d09-k0103

name: "KSB-D09-K0103" description: "AI-Optimized Study Design: Understanding of AI applications in post-authorization study design including machine learning-assis..." version: "1.0.0" domain: "D09" domain_name: "Post-Authorization Studies" type: "Knowledge" proficiency_level: "L4" bloom_level: "evaluate" triggers: - "explain ai-optimized study design" - "what is ai-optimized study design" - "evaluate ai-optimized study design" epa_mapping: "EPA-02, EPA-04, EPA-05" cpa_mapping: "CPA-02, CPA-07" regulatory_refs: ""

KSB-D09-K0103: AI-Optimized Study Design

Overview

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

Description

Understanding of AI applications in post-authorization study design including machine learning-assisted protocol optimization, AI-powered sample size estimation, intelligent endpoint selection, and predictive modeling for study feasibility assessment.

Context

• Major Section: AI in Post-Authorization Studies
• Section: AI Study Design

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-optimized study design
2. Apply evaluate level cognitive skills to evaluate 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 applications in post-authorization study design including machine learning-assisted protocol optimization, AI-powered sample size estimation, intelligent endpoint selection, and predictive modeling for study feasibility assessment.

Assessment Criteria

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

Related Skills

• Other D09 skills in AI Study Design
• Cross-domain integrations per DAG architecture

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