ksb-d10-k0005

name: "KSB-D10-K0005" description: "Stakeholder Value Integration: Patient preference elicitation, physician judgment incorporation, regulatory perspective integration..." version: "1.0.0" domain: "D10" domain_name: "Benefit-Risk Assessment" type: "Knowledge" proficiency_level: "L1" bloom_level: "understand" triggers: - "explain stakeholder value integration" - "what is stakeholder value integration" - "explain stakeholder value integration" epa_mapping: "EPA-03, EPA-05, EPA-08" cpa_mapping: "CPA-02, CPA-03" regulatory_refs: "CIOMS-X, ICH-E2E"

KSB-D10-K0005: Stakeholder Value Integration

Overview

Domain: D10 - Benefit-Risk Assessment Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand

Description

Patient preference elicitation, physician judgment incorporation, regulatory perspective integration, societal value consideration, cultural adaptation requirements

Context

• Major Section: Benefit-Risk Assessment Theoretical Foundation and Decision Science
• Section: Decision-Making Framework Architecture and Methodological Foundation

EPA Mapping

• EPA-03:3006-3008
• EPA-05:3011-3012
• EPA-08:3018-3019

CPA Pathway

• CPA-02, CPA-03

Regulatory References

• CIOMS-X
• ICH-E2E

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in stakeholder value integration
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (CIOMS-X, ICH-E2E)
4. Connect to related EPAs: EPA-03, EPA-05, EPA-08

Key Competencies

• Patient preference elicitation, physician judgment incorporation, regulatory perspective integration, societal value consideration, cultural adaptation requirements

Assessment Criteria

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

Related Skills

• Other D10 skills in Decision-Making Framework Architecture and Methodological Foundation
• Cross-domain integrations per DAG architecture

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