Ksb D05 K0102

CPA Pathway

• CPA-01, CPA-07

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in ai-enabled trial safety prediction
2. Apply analyze level cognitive skills to analyze the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-02, EPA-04, EPA-08

Key Competencies

• Mastery of AI applications for predicting clinical trial safety outcomes including enrollment risk modeling, adverse event rate forecasting, dropout prediction algorithms, and safety stopping boundary optimization using machine learning.

Assessment Criteria

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

Related Skills

• Other D05 skills in Predictive Trial Safety
• Cross-domain integrations per DAG architecture

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