| 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
Regulatory References
- FDA-STAT-001
- FDA-CFR-006
- EMA-GVP-009
Instructions
When this skill is activated, Claude should:
- Demonstrate L4 proficiency in pragmatic clinical trial integration
- Apply create level cognitive skills to create the topic
- Reference relevant regulatory guidance (FDA-STAT-001, FDA-CFR-006, EMA-GVP-009)
- 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
Generated from PV KSB Framework v1.0 | 2025-12-31
