Ksb D10 K0015

• CPA-02, CPA-03

Regulatory References

• CIOMS-X
• ICH-E2E

Instructions

When this skill is activated, Claude should:

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

Key Competencies

• Novel endpoint development, real-world evidence acceptance, digital health integration, adaptive regulatory pathways

Assessment Criteria

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

Related Skills

• Other D10 skills in Regulatory Science and Policy Integration Framework
• Cross-domain integrations per DAG architecture

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