Ksb D15 K0003

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 L5 proficiency in conference and grey literature
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

• Understanding of non-traditional information sources including conference abstracts, regulatory submissions, industry reports, and white papers, with knowledge of access methods, quality assessment criteria, and appropriate use in safety evaluation considering publication bias and limited peer review.

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