ksb-d09-k0037

name: "KSB-D09-K0037" description: "Study Conduct Quality Control: Site monitoring procedures, investigator training, protocol deviation management, audit preparation ..." version: "1.0.0" domain: "D09" domain_name: "Post-Authorization Studies" type: "Knowledge" proficiency_level: "L1" bloom_level: "understand" triggers: - "explain study conduct quality control" - "what is study conduct quality control" - "explain study conduct quality control" epa_mapping: "EPA-02, EPA-04, EPA-05" cpa_mapping: "CPA-02, CPA-07" regulatory_refs: "FDA-STAT-001, FDA-CFR-006, EMA-GVP-009"

KSB-D09-K0037: Study Conduct Quality Control

Overview

Domain: D09 - Post-Authorization Studies Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand

Description

Site monitoring procedures, investigator training, protocol deviation management, audit preparation protocols

Context

• Major Section: Post-Authorization Study Design Framework and Methodological Foundation
• Section: Quality Management and Validation Framework

EPA Mapping

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

CPA Pathway

• CPA-02, CPA-07

Regulatory References

• FDA-STAT-001
• FDA-CFR-006
• EMA-GVP-009

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in study conduct quality control
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (FDA-STAT-001, FDA-CFR-006, EMA-GVP-009)
4. Connect to related EPAs: EPA-02, EPA-04, EPA-05

Key Competencies

• Site monitoring procedures, investigator training, protocol deviation management, audit preparation protocols

Assessment Criteria

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

Related Skills

• Other D09 skills in Quality Management and Validation Framework
• Cross-domain integrations per DAG architecture

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