ksb-d10-k0002

name	KSB-D10-K0002
description	Quantitative Assessment Methodologies: Quality-Adjusted Life Years (QALY) calculation, Disability-Adjusted Life Years (DALY) analysis, Numb...
version	1.0.0
domain	D10
domain_name	Benefit-Risk Assessment
type	Knowledge
proficiency_level	L1
bloom_level	understand
triggers	["explain quantitative assessment methodologies","what is quantitative assessment methodologies","explain quantitative assessment methodologies"]
epa_mapping	EPA-03, EPA-05, EPA-08
cpa_mapping	CPA-02, CPA-03
regulatory_refs	CIOMS-X, ICH-E2E

KSB-D10-K0002: Quantitative Assessment Methodologies

Overview

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

Description

Quality-Adjusted Life Years (QALY) calculation, Disability-Adjusted Life Years (DALY) analysis, Number Needed to Treat/Harm (NNT/NNH) applications, Incremental Cost-Effectiveness Ratios (ICER)

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 quantitative assessment methodologies
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

• Quality-Adjusted Life Years (QALY) calculation, Disability-Adjusted Life Years (DALY) analysis, Number Needed to Treat/Harm (NNT/NNH) applications, Incremental Cost-Effectiveness Ratios (ICER)

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

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