Ksb D06 K0008

• CPA-01, CPA-03

Regulatory References

• FDA-CFR-001
• FDA-CFR-003
• ICH-E2A
• ICH-E2B(R3)
• ICH-E2D
• EMA-GVP-003

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in temporary harm events
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (FDA-CFR-001, FDA-CFR-003, ICH-E2A, ICH-E2B(R3), ICH-E2D, EMA-GVP-003)
4. Connect to related EPAs: EPA-01, EPA-07, EPA-09

Key Competencies

• Errors requiring intervention or monitoring, reversible effects, recovery timelines

Assessment Criteria

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

Related Skills

• Other D06 skills in Severity and Outcome Assessment
• Cross-domain integrations per DAG architecture

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