Ksb D02 K0012

Regulatory References

• ICH-E2A
• FDA-GUID-001

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in causality assessment methods
2. Apply understand level cognitive skills to explain 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

• WHO-UMC, Naranjo, Bradford-Hill criteria

Assessment Criteria

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

Related Skills

• Other D02 skills in Clinical Assessment Frameworks
• Cross-domain integrations per DAG architecture

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