KSB-D04-K0044: Regulatory Compliance Verification

KSB-D04-K0044: Regulatory Compliance Verification

Overview

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

Description

AI checking of submission requirements and format standards

Context

• Major Section: Global Regulatory Requirements for ICSRs
• Section: Quality Assurance and Validation

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 regulatory compliance verification
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

• AI checking of submission requirements and format standards

Assessment Criteria

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

Related Skills

• Other D04 skills in Quality Assurance and Validation
• Cross-domain integrations per DAG architecture

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