ksb-d05-k0014

name	KSB-D05-K0014
description	Quality Management Systems: ICH Q9 and Q10 adaptation for clinical trials, CAPA implementation, continuous improvement...
version	1.0.0
domain	D05
domain_name	Clinical Trials PV
type	Knowledge
proficiency_level	L1
bloom_level	apply
triggers	["explain quality management systems","what is quality management systems","apply quality management systems"]
epa_mapping	EPA-02, EPA-04, EPA-08
cpa_mapping	CPA-01, CPA-07
regulatory_refs	EMA-REG-004, ICH-E6

KSB-D05-K0014: Quality Management Systems

Overview

Domain: D05 - Clinical Trials PV Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Apply

Description

ICH Q9 and Q10 adaptation for clinical trials, CAPA implementation, continuous improvement

Context

• Major Section: Clinical Trial Regulatory Framework and Safety Requirements
• Section: Risk-Based Monitoring and Quality Assurance

EPA Mapping

• EPA-02:3004-3005
• EPA-04:3009-3010
• EPA-08:3018-3019

CPA Pathway

• CPA-01, CPA-07

Regulatory References

• EMA-REG-004
• ICH-E6

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in quality management systems
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (EMA-REG-004, ICH-E6)
4. Connect to related EPAs: EPA-02, EPA-04, EPA-08

Key Competencies

• ICH Q9 and Q10 adaptation for clinical trials, CAPA implementation, continuous improvement

Assessment Criteria

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

Related Skills

• Other D05 skills in Risk-Based Monitoring and Quality Assurance
• Cross-domain integrations per DAG architecture

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