Ksb D05 K0011

• CPA-01, CPA-07

Regulatory References

• EMA-REG-004
• ICH-E6

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in risk assessment methodologies
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (EMA-REG-004, ICH-E6)
4. Connect to related EPAs: EPA-02, EPA-04, EPA-08

Key Competencies

• Protocol-specific risk evaluation, patient population considerations, investigational product characteristics

Assessment Criteria

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

Related Skills

• Other D05 skills in Risk-Based Monitoring and Quality Assurance
• Cross-domain integrations per DAG architecture

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