ksb-d03-k0040

name: "KSB-D03-K0040" description: "Alert Generation: Intelligent warning systems for important ADR development..." version: "1.0.0" domain: "D03" domain_name: "Important ADRs Recognition" type: "Knowledge" proficiency_level: "L4" bloom_level: "create" triggers: - "explain alert generation" - "what is alert generation" - "create alert generation" 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-K0040: Alert Generation

Overview

Domain: D03 - Important ADRs Recognition Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Create

Description

Intelligent warning systems for important ADR development

Context

• Major Section: Organ System-Specific ADR Patterns
• Section: Real-Time Monitoring Systems

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 L4 proficiency in alert generation
2. Apply create level cognitive skills to create 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

• Intelligent warning systems for important ADR development

Assessment Criteria

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

Related Skills

• Other D03 skills in Real-Time Monitoring Systems
• Cross-domain integrations per DAG architecture

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