Ksb D05 K0104

• CPA-01, CPA-07

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in ai 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 trial safety outcomes including adverse event rate forecasting, safety-related discontinuation modeling, serious adverse event prediction, and trial risk stratification algorithms.

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 AI
• Cross-domain integrations per DAG architecture

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