By name: "KSB-D05-K0104" description: "AI Trial Safety Prediction: Mastery of AI applications for predicting trial safety outcomes including adverse event rate forecas..." version: "1.0.0" domain: "D05" domain_name: "Clinical Trials PV" type: "Knowledge" proficiency_level: "L4" bloom_level: "analyze" triggers: - "explain ai trial safety prediction" - "what is ai trial safety prediction" - "analyze ai trial safety prediction" epa_mapping: "EPA-02, EPA-04, EPA-08" cpa_mapping: "CPA-01, CPA-07" regulatory_refs: ""
KSB-D05-K0104: AI Trial Safety Prediction
Overview
Domain: D05 - Clinical Trials PV Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Analyze
Description
Mastery of AI applications for predicting trial safety outcomes including adverse event rate forecasting, safety-related discontinuation modeling, serious adverse event prediction, and trial risk stratification algorithms.
Context
- Major Section: AI in Clinical Trial Safety
- Section: Predictive Trial AI
EPA Mapping
- EPA-02:3004-3005
- EPA-04:3009-3010
- EPA-08:3018-3019
CPA Pathway
- CPA-01, CPA-07
Regulatory References
- General PV competency
Instructions
When this skill is activated, Claude should:
- Demonstrate L4 proficiency in ai trial safety prediction
- 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
- Mastery of AI applications for predicting trial safety outcomes including adverse event rate forecasting, safety-related discontinuation modeling, serious adverse event prediction, and trial risk stratification algorithms.
Assessment Criteria
- Can analyze core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D05 skills in Predictive Trial AI
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31