ksb-d05-k0104

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:

1. Demonstrate L4 proficiency in ai trial safety prediction
2. Apply analyze level cognitive skills to analyze the topic
3. Reference relevant regulatory guidance (general PV standards)
4. 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

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