| name | KSB-D05-K0105 |
| description | AI-Enabled Adaptive Trial Designs: Understanding of AI applications in adaptive trial designs including response-adaptive randomization... |
| version | 1.0.0 |
| domain | D05 |
| domain_name | Clinical Trials PV |
| type | Knowledge |
| proficiency_level | L5 |
| bloom_level | evaluate |
| triggers | ["explain ai-enabled adaptive trial designs","what is ai-enabled adaptive trial designs","evaluate ai-enabled adaptive trial designs"] |
| epa_mapping | EPA-02, EPA-04, EPA-08 |
| cpa_mapping | CPA-01, CPA-07 |
| regulatory_refs | |
KSB-D05-K0105: AI-Enabled Adaptive Trial Designs
Overview
Domain: D05 - Clinical Trials PV
Type: Knowledge
Proficiency Level: L5 (Expert - Can supervise others)
Bloom Level: Evaluate
Description
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.
Context
- Major Section: AI in Clinical Trial Safety
- Section: Adaptive Trial AI
EPA Mapping
- EPA-02:3004-3005
- EPA-04:3009-3010
- EPA-08:3018-3019
CPA Pathway
Regulatory References
Instructions
When this skill is activated, Claude should:
- Demonstrate L5 proficiency in ai-enabled adaptive trial designs
- Apply evaluate level cognitive skills to evaluate the topic
- Reference relevant regulatory guidance (general PV standards)
- 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
