Ksb D10 K0042

• EPA-03:3006-3008
• EPA-05:3011-3012
• EPA-08:3018-3019

CPA Pathway

• CPA-02, CPA-03

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L3 proficiency in ai use case credibility assessment
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-03, EPA-05, EPA-08

Key Competencies

• Knowledge of credibility assessment methodologies for AI use cases in pharmacovigilance including fit-for-purpose evaluation, operational feasibility analysis, regulatory acceptability assessment, and evidence requirements for supporting AI deployment decisions. Understanding of CIOMS WG XIV credibility framework and alignment with ICH E9(R1) estimand framework principles.

Assessment Criteria

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

Related Skills

• Other D10 skills in Risk-based AI Implementation
• Cross-domain integrations per DAG architecture

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