ksb-d03-k0033

name: "KSB-D03-K0033" description: "Severity Prediction: Algorithms predicting ADR severity and outcome based on early presentations..." version: "1.0.0" domain: "D03" domain_name: "Important ADRs Recognition" type: "Knowledge" proficiency_level: "L1" bloom_level: "understand" triggers: - "explain severity prediction" - "what is severity prediction" - "explain severity prediction" epa_mapping: "EPA-01, EPA-02, EPA-05" cpa_mapping: "CPA-01, CPA-02" regulatory_refs: "ICH-E2A, EMA-GVP-014, EMA-GVP-015"

KSB-D03-K0033: Severity Prediction

Overview

Domain: D03 - Important ADRs Recognition Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand

Description

Algorithms predicting ADR severity and outcome based on early presentations

Context

• Major Section: Organ System-Specific ADR Patterns
• Section: Predictive Modeling and Risk Stratification

EPA Mapping

• EPA-01:3001-3003
• EPA-02:3004-3005
• EPA-05:3011-3012

CPA Pathway

• CPA-01, CPA-02

Regulatory References

• ICH-E2A
• EMA-GVP-014
• EMA-GVP-015

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in severity prediction
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (ICH-E2A, EMA-GVP-014, EMA-GVP-015)
4. Connect to related EPAs: EPA-01, EPA-02, EPA-05

Key Competencies

• Algorithms predicting ADR severity and outcome based on early presentations

Assessment Criteria

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

Related Skills

• Other D03 skills in Predictive Modeling and Risk Stratification
• Cross-domain integrations per DAG architecture

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