Ksb D08 K0016

• CPA-02

Regulatory References

• FDA-GUID-006
• EMA-GVP-005
• EMA-GVP-010
• CIOMS-VIII

Instructions

When this skill is activated, Claude should:

1. Demonstrate L3 proficiency in spontaneous reporting system analysis
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (FDA-GUID-006, EMA-GVP-005, EMA-GVP-010, CIOMS-VIII)
4. Connect to related EPAs: EPA-04, EPA-05

Key Competencies

• Global database integration (FDA FAERS, EudraVigilance, WHO VigiBase), reporting bias adjustment, duplicate detection across systems

Assessment Criteria

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

Related Skills

• Other D08 skills in Comprehensive Data Source Management
• Cross-domain integrations per DAG architecture

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