ksb-d11-k0020

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:

1. Demonstrate L1 proficiency in pilot testing and validation
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (FDA-STAT-002, EMA-GVP-002, EMA-GVP-012, UK-MHRA-009)
4. 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

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