ksb-d02-k0019

name: "KSB-D02-K0019" description: "Pregnancy and Lactation: Teratogenicity assessment, maternal-fetal safety considerations..." version: "1.0.0" domain: "D02" domain_name: "Clinical Aspects of ADRs" type: "Knowledge" proficiency_level: "L4" bloom_level: "evaluate" triggers: - "explain pregnancy and lactation" - "what is pregnancy and lactation" - "evaluate pregnancy and lactation" epa_mapping: "EPA-01, EPA-02, EPA-05" cpa_mapping: "CPA-01, CPA-02" regulatory_refs: "ICH-E2A, FDA-GUID-001"

KSB-D02-K0019: Pregnancy and Lactation

Overview

Domain: D02 - Clinical Aspects of ADRs Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Evaluate

Description

Teratogenicity assessment, maternal-fetal safety considerations

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 L4 proficiency in pregnancy and lactation
2. Apply evaluate level cognitive skills to evaluate 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

• Teratogenicity assessment, maternal-fetal safety considerations

Assessment Criteria

• Can evaluate 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