ksb-d02-k0020

name: "KSB-D02-K0020" description: "Renal and Hepatic Impairment: Dose adjustment requirements, enhanced monitoring needs..." version: "1.0.0" domain: "D02" domain_name: "Clinical Aspects of ADRs" type: "Knowledge" proficiency_level: "L3" bloom_level: "apply" triggers: - "explain renal and hepatic impairment" - "what is renal and hepatic impairment" - "apply renal and hepatic impairment" epa_mapping: "EPA-01, EPA-02, EPA-05" cpa_mapping: "CPA-01, CPA-02" regulatory_refs: "ICH-E2A, FDA-GUID-001"

KSB-D02-K0020: Renal and Hepatic Impairment

Overview

Domain: D02 - Clinical Aspects of ADRs Type: Knowledge Proficiency Level: L3 (Competent - Minimal supervision) Bloom Level: Apply

Description

Dose adjustment requirements, enhanced monitoring needs

Context

• Major Section: ADR Classification Systems
• Section: Special Population Considerations

EPA Mapping

• EPA-01:3001-3003
• EPA-02:3004-3005
• EPA-05:3011-3012

CPA Pathway

• CPA-01, CPA-02

Regulatory References

• ICH-E2A
• FDA-GUID-001

Instructions

When this skill is activated, Claude should:

1. Demonstrate L3 proficiency in renal and hepatic impairment
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (ICH-E2A, FDA-GUID-001)
4. Connect to related EPAs: EPA-01, EPA-02, EPA-05

Key Competencies

• Dose adjustment requirements, enhanced monitoring needs

Assessment Criteria

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

Related Skills

• Other D02 skills in Special Population Considerations
• Cross-domain integrations per DAG architecture

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