| name | KSB-D05-K0103 |
| description | AI-Enhanced Safety Monitoring Boards: Understanding of AI applications supporting Data Safety Monitoring Boards including automated interi... |
| version | 1.0.0 |
| domain | D05 |
| domain_name | Clinical Trials PV |
| type | Knowledge |
| proficiency_level | L4 |
| bloom_level | analyze |
| triggers | ["explain ai-enhanced safety monitoring boards","what is ai-enhanced safety monitoring boards","analyze ai-enhanced safety monitoring boards"] |
| epa_mapping | EPA-02, EPA-04, EPA-08 |
| cpa_mapping | CPA-01, CPA-07 |
| regulatory_refs | |
KSB-D05-K0103: AI-Enhanced Safety Monitoring Boards
Overview
Domain: D05 - Clinical Trials PV
Type: Knowledge
Proficiency Level: L4 (Proficient - Independent practice)
Bloom Level: Analyze
Description
Understanding of AI applications supporting Data Safety Monitoring Boards including automated interim analysis, AI-generated safety summaries, predictive enrollment modeling, and real-time safety dashboard development.
Context
- Major Section: AI in Clinical Trial Safety
- Section: AI Trial Monitoring
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 L4 proficiency in ai-enhanced safety monitoring boards
- 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-08
Key Competencies
- Understanding of AI applications supporting Data Safety Monitoring Boards including automated interim analysis, AI-generated safety summaries, predictive enrollment modeling, and real-time safety dashboard development.
Assessment Criteria
- Can analyze core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D05 skills in AI Trial Monitoring
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31
