ksb-d10-k0042

name	KSB-D10-K0042
description	AI Use Case Credibility Assessment: Knowledge of credibility assessment methodologies for AI use cases in pharmacovigilance including fi...
version	1.0.0
domain	D10
domain_name	Benefit-Risk Assessment
type	Knowledge
proficiency_level	L3
bloom_level	apply
triggers	["explain ai use case credibility assessment","what is ai use case credibility assessment","apply ai use case credibility assessment"]
epa_mapping	EPA-03, EPA-05, EPA-08
cpa_mapping	CPA-02, CPA-03
regulatory_refs

KSB-D10-K0042: AI Use Case Credibility Assessment

Overview

Domain: D10 - Benefit-Risk Assessment Type: Knowledge Proficiency Level: L3 (Competent - Minimal supervision) Bloom Level: Apply

Description

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.

Context

• Major Section: AI Risk Assessment and Benefit-Risk Integration
• Section: Risk-based AI Implementation

EPA Mapping

• 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

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