ksb-d09-k0005

name	KSB-D09-K0005
description	Pragmatic Clinical Trial Integration: Randomized controlled studies in real-world settings, cluster randomization approaches, stepped-wedg...
version	1.0.0
domain	D09
domain_name	Post-Authorization Studies
type	Knowledge
proficiency_level	L4
bloom_level	create
triggers	["explain pragmatic clinical trial integration","what is pragmatic clinical trial integration","create pragmatic clinical trial integration"]
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-K0005: Pragmatic Clinical Trial Integration

Overview

Domain: D09 - Post-Authorization Studies Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Create

Description

Randomized controlled studies in real-world settings, cluster randomization approaches, stepped-wedge designs, adaptive trial methodologies

Context

• Major Section: Post-Authorization Study Design Framework and Methodological Foundation
• Section: Observational Study Architecture and Design Principles

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 L4 proficiency in pragmatic clinical trial integration
2. Apply create level cognitive skills to create 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

• Randomized controlled studies in real-world settings, cluster randomization approaches, stepped-wedge designs, adaptive trial methodologies

Assessment Criteria

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

Related Skills

• Other D09 skills in Observational Study Architecture and Design Principles
• Cross-domain integrations per DAG architecture

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