Ksb D04 K0021

Regulatory References

• ICH-M1 (MedDRA)
• ICH-E2B(R3)

Instructions

When this skill is activated, Claude should:

1. Demonstrate L3 proficiency in causality assessment
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (ICH-M1 (MedDRA), ICH-E2B(R3))
4. Connect to related EPAs: EPA-01, EPA-04, EPA-09

Key Competencies

• WHO-UMC criteria, Naranjo scale, company-specific algorithms

Assessment Criteria

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

Related Skills

• Other D04 skills in Medical and Scientific Evaluation
• Cross-domain integrations per DAG architecture

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