Ksb D09 K0038

• CPA-02, CPA-07

Regulatory References

• FDA-STAT-001
• FDA-CFR-006
• EMA-GVP-009

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in statistical analysis plan development
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (FDA-STAT-001, FDA-CFR-006, EMA-GVP-009)
4. Connect to related EPAs: EPA-02, EPA-04, EPA-05

Key Competencies

• Pre-specified analysis protocols, sensitivity analysis planning, interim analysis procedures, stopping rule definition

Assessment Criteria

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

Related Skills

• Other D09 skills in Quality Management and Validation Framework
• Cross-domain integrations per DAG architecture

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