Ksb D10 K0016

• CPA-02, CPA-03

Regulatory References

• CIOMS-X
• ICH-E2E

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in evidence hierarchy and quality assessment
2. Apply evaluate level cognitive skills to evaluate the topic
3. Reference relevant regulatory guidance (CIOMS-X, ICH-E2E)
4. Connect to related EPAs: EPA-03, EPA-05, EPA-08

Key Competencies

• Study design evaluation, bias assessment methodologies, evidence quality grading (GRADE), systematic review standards

Assessment Criteria

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

Related Skills

• Other D10 skills in Systematic Evidence Evaluation and Integration
• Cross-domain integrations per DAG architecture

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