Ksb D15 K0004

CPA Pathway

• CPA-05, CPA-07

Regulatory References

• ICH-E2D Sec 3.2
• MULTI-LIT-001

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in clinical trial databases
2. Apply analyze level cognitive skills to analyze the topic
3. Reference relevant regulatory guidance (ICH-E2D Sec 3.2, MULTI-LIT-001)
4. Connect to related EPAs: EPA-02, EPA-04

Key Competencies

• Comprehensive knowledge of clinical trial registries (ClinicalTrials.gov, EudraCT, WHO ICTRP) and results databases, understanding trial design information, results reporting requirements, and limitations that influence interpretation of safety data from investigational studies.

Assessment Criteria

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

Related Skills

• Other D15 skills in Traditional Information Sources and Management
• Cross-domain integrations per DAG architecture

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