ksb-d15-k0002

name	KSB-D15-K0002
description	Regulatory Information Architecture: Mastery of global regulatory databases including FDA FAERS, EudraVigilance, WHO VigiBase, and nation...
version	1.0.0
domain	D15
domain_name	Sources of Information
type	Knowledge
proficiency_level	L5
bloom_level	analyze
triggers	["explain regulatory information architecture","what is regulatory information architecture","analyze regulatory information architecture"]
epa_mapping	EPA-02, EPA-04
cpa_mapping	CPA-05, CPA-07
regulatory_refs	ICH-E2D Sec 3.2, MULTI-LIT-001

KSB-D15-K0002: Regulatory Information Architecture

Overview

Domain: D15 - Sources of Information Type: Knowledge Proficiency Level: L5 (Expert - Can supervise others) Bloom Level: Analyze

Description

Mastery of global regulatory databases including FDA FAERS, EudraVigilance, WHO VigiBase, and national regulatory repositories, understanding data structure, access limitations, reporting requirements, and temporal factors that influence data interpretation and utility for safety assessment.

Context

• Major Section: Core Knowledge
• Section: Traditional Information Sources and Management

EPA Mapping

• EPA-02:3004-3005
• EPA-04:3009-3010

CPA Pathway

• CPA-05, CPA-07

Regulatory References

• ICH-E2D Sec 3.2
• MULTI-LIT-001

Instructions

When this skill is activated, Claude should:

1. Demonstrate L5 proficiency in regulatory information architecture
2. Apply analyze level cognitive skills to analyze the topic
3. Reference relevant regulatory guidance (ICH-E2D Sec 3.2, MULTI-LIT-001)
4. Connect to related EPAs: EPA-02, EPA-04

Key Competencies

• Mastery of global regulatory databases including FDA FAERS, EudraVigilance, WHO VigiBase, and national regulatory repositories, understanding data structure, access limitations, reporting requirements, and temporal factors that influence data interpretation and utility for safety assessment.

Assessment Criteria

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

Related Skills

• Other D15 skills in Traditional Information Sources and Management
• Cross-domain integrations per DAG architecture

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