Ksb D05 K0105

• CPA-01, CPA-07

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L5 proficiency in ai-enabled adaptive trial designs
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-08

Key Competencies

• Understanding of AI applications in adaptive trial designs including response-adaptive randomization, AI-driven dose finding, platform trial optimization, and real-time safety-efficacy balancing algorithms.

Assessment Criteria

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

Related Skills

• Other D05 skills in Adaptive Trial AI
• Cross-domain integrations per DAG architecture

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