By name: "KSB-D11-K0020" description: "Pilot Testing and Validation: Proof-of-concept studies, feasibility assessment, acceptability evaluation, preliminary effectivenes..." version: "1.0.0" domain: "D11" domain_name: "Risk Management" type: "Knowledge" proficiency_level: "L1" bloom_level: "apply" triggers: - "explain pilot testing and validation" - "what is pilot testing and validation" - "apply pilot testing and validation" epa_mapping: "EPA-07, EPA-08, EPA-16" cpa_mapping: "CPA-03" regulatory_refs: "FDA-STAT-002, EMA-GVP-002, EMA-GVP-012, UK-MHRA-009"
KSB-D11-K0020: Pilot Testing and Validation
Overview
Domain: D11 - Risk Management Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Apply
Description
Proof-of-concept studies, feasibility assessment, acceptability evaluation, preliminary effectiveness measurement, implementation barrier identification
Context
- Major Section: Risk Management Theoretical Foundation and Implementation Science
- Section: Evidence-Based Intervention Development and Validation
EPA Mapping
- EPA-07:3016-3017
- EPA-08:3018-3019
- EPA-16:3035-3036
CPA Pathway
- CPA-03
Regulatory References
- FDA-STAT-002
- EMA-GVP-002
- EMA-GVP-012
- UK-MHRA-009
Instructions
When this skill is activated, Claude should:
- Demonstrate L1 proficiency in pilot testing and validation
- Apply apply level cognitive skills to apply the topic
- Reference relevant regulatory guidance (FDA-STAT-002, EMA-GVP-002, EMA-GVP-012, UK-MHRA-009)
- Connect to related EPAs: EPA-07, EPA-08, EPA-16
Key Competencies
- Proof-of-concept studies, feasibility assessment, acceptability evaluation, preliminary effectiveness measurement, implementation barrier identification
Assessment Criteria
- Can apply core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D11 skills in Evidence-Based Intervention Development and Validation
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31