Ksb D04 K0044

---
name: ksb-d04-k0044
title: 'KSB-D04-K0044: Regulatory Compliance Verification'
description: 'Regulatory Compliance Verification: AI checking of submission requirements and format standards...'
author: nexvigilant
author_url: https://github.com/nexvigilant/.true/tree/main/knowledge/pv-ksb/ksb-d04-k0044-regulatory-compliance-verification
license: MIT
version: 0.1.0
execution_mode: open
jurisdiction: general
practice: regulatory
language: en
---

# 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

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