ksb-d08-k0044

name: "KSB-D08-K0044" description: "CIOMS WG XIV Fairness Standards: Mastery of CIOMS Working Group XIV recommendations on fairness and equity in AI-driven pharmacovigil..." version: "1.0.0" domain: "D08" domain_name: "Signal Detection & Management" type: "Knowledge" proficiency_level: "L4" bloom_level: "evaluate" triggers: - "explain cioms wg xiv fairness standards" - "what is cioms wg xiv fairness standards" - "evaluate cioms wg xiv fairness standards" epa_mapping: "EPA-04, EPA-05" cpa_mapping: "CPA-02" regulatory_refs: ""

KSB-D08-K0044: CIOMS WG XIV Fairness Standards

Overview

Domain: D08 - Signal Detection & Management Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Evaluate

Description

Mastery of CIOMS Working Group XIV recommendations on fairness and equity in AI-driven pharmacovigilance including bias prevention principles, equity-by-design methodology, continuous fairness monitoring requirements, and regulatory expectations for demonstrating algorithmic fairness in safety signal detection systems.

Context

• Major Section: AI Integration and Advanced Analytics
• Section: AI Fairness and Equity in Signal Detection

EPA Mapping

• EPA-04:3009-3010
• EPA-05:3011-3012

CPA Pathway

• CPA-02

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in cioms wg xiv fairness standards
2. Apply evaluate level cognitive skills to evaluate the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-04, EPA-05

Key Competencies

• Mastery of CIOMS Working Group XIV recommendations on fairness and equity in AI-driven pharmacovigilance including bias prevention principles, equity-by-design methodology, continuous fairness monitoring requirements, and regulatory expectations for demonstrating algorithmic fairness in safety signal detection systems.

Assessment Criteria

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

Related Skills

• Other D08 skills in AI Fairness and Equity in Signal Detection
• Cross-domain integrations per DAG architecture

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