ksb-d04-k0001

name: "KSB-D04-K0001" description: "ICH E2A Guidelines: Definitions of adverse events, serious adverse events, and reporting timelines..." version: "1.0.0" domain: "D04" domain_name: "Individual Case Safety Reports" type: "Knowledge" proficiency_level: "L1" bloom_level: "understand" triggers: - "explain ich e2a guidelines" - "what is ich e2a guidelines" - "explain ich e2a guidelines" epa_mapping: "EPA-01, EPA-04, EPA-09" cpa_mapping: "CPA-01, CPA-04" regulatory_refs: "ICH-M1 (MedDRA), ICH-E2B(R3)"

KSB-D04-K0001: ICH E2A Guidelines

Overview

Domain: D04 - Individual Case Safety Reports Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand

Description

Definitions of adverse events, serious adverse events, and reporting timelines

Context

• Major Section: Global Regulatory Requirements for ICSRs
• Section: International Harmonization Standards

EPA Mapping

• EPA-01:3001-3003
• EPA-04:3009-3010
• EPA-09:3020-3022

CPA Pathway

• CPA-01, CPA-04

Regulatory References

• ICH-M1 (MedDRA)
• ICH-E2B(R3)

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in ich e2a guidelines
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (ICH-M1 (MedDRA), ICH-E2B(R3))
4. Connect to related EPAs: EPA-01, EPA-04, EPA-09

Key Competencies

• Definitions of adverse events, serious adverse events, and reporting timelines

Assessment Criteria

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

Related Skills

• Other D04 skills in International Harmonization Standards
• Cross-domain integrations per DAG architecture

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