ksb-d07-k0006

name	KSB-D07-K0006
description	Relational Database Design: Entity relationship models, normalization standards, referential integrity, performance optimization...
version	1.0.0
domain	D07
domain_name	Spontaneous Reporting Systems
type	Knowledge
proficiency_level	L1
bloom_level	understand
triggers	["explain relational database design","what is relational database design","explain relational database design"]
epa_mapping	EPA-02, EPA-04, EPA-05
cpa_mapping	CPA-02, CPA-05
regulatory_refs	FDA-CFR-002, ICH-E2C(R2), ICH-E2F, EMA-GVP-004

KSB-D07-K0006: Relational Database Design

Overview

Domain: D07 - Spontaneous Reporting Systems Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand

Description

Entity relationship models, normalization standards, referential integrity, performance optimization

Context

• Major Section: Global Spontaneous Reporting System Architecture
• Section: Database Structure and Technical Architecture

EPA Mapping

• EPA-02:3004-3005
• EPA-04:3009-3010
• EPA-05:3011-3012

CPA Pathway

• CPA-02, CPA-05

Regulatory References

• FDA-CFR-002
• ICH-E2C(R2)
• ICH-E2F
• EMA-GVP-004

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in relational database design
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (FDA-CFR-002, ICH-E2C(R2), ICH-E2F, EMA-GVP-004)
4. Connect to related EPAs: EPA-02, EPA-04, EPA-05

Key Competencies

• Entity relationship models, normalization standards, referential integrity, performance optimization

Assessment Criteria

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

Related Skills

• Other D07 skills in Database Structure and Technical Architecture
• Cross-domain integrations per DAG architecture

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