ksb-d11-k0001

name	KSB-D11-K0001
description	Risk Assessment Methodology: Hazard identification principles, exposure assessment techniques, dose-response analysis, risk chara...
version	1.0.0
domain	D11
domain_name	Risk Management
type	Knowledge
proficiency_level	L4
bloom_level	evaluate
triggers	["explain risk assessment methodology","what is risk assessment methodology","evaluate risk assessment methodology"]
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-K0001: Risk Assessment Methodology

Overview

Domain: D11 - Risk Management Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Evaluate

Description

Hazard identification principles, exposure assessment techniques, dose-response analysis, risk characterization integration, population impact modeling

Context

• Major Section: Risk Management Theoretical Foundation and Implementation Science
• Section: Risk Characterization and Intervention Design Framework

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 L4 proficiency in risk assessment methodology
2. Apply evaluate level cognitive skills to evaluate 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

• Hazard identification principles, exposure assessment techniques, dose-response analysis, risk characterization integration, population impact modeling

Assessment Criteria

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

Related Skills

• Other D11 skills in Risk Characterization and Intervention Design Framework
• Cross-domain integrations per DAG architecture

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