ksb-d08-k0049

name	KSB-D08-K0049
description	Model Interpretability Requirements: Understanding of interpretability requirements for AI models in safety-critical pharmacovigilance ap...
version	1.0.0
domain	D08
domain_name	Signal Detection & Management
type	Knowledge
proficiency_level	L3
bloom_level	apply
triggers	["explain model interpretability requirements","what is model interpretability requirements","apply model interpretability requirements"]
epa_mapping	EPA-04, EPA-05
cpa_mapping	CPA-02
regulatory_refs

KSB-D08-K0049: Model Interpretability Requirements

Overview

Domain: D08 - Signal Detection & Management Type: Knowledge Proficiency Level: L3 (Competent - Minimal supervision) Bloom Level: Apply

Description

Understanding of interpretability requirements for AI models in safety-critical pharmacovigilance applications including distinction between inherently interpretable models (decision trees, linear models) and post-hoc interpretability methods, trade-offs between model complexity and interpretability, and regulatory expectations for model transparency. Knowledge of interpretability standards across FDA, EMA, and CIOMS frameworks.

Context

• Major Section: AI Integration and Advanced Analytics
• Section: AI Transparency and Explainability

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 L3 proficiency in model interpretability requirements
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-04, EPA-05

Key Competencies

• Understanding of interpretability requirements for AI models in safety-critical pharmacovigilance applications including distinction between inherently interpretable models (decision trees, linear models) and post-hoc interpretability methods, trade-offs between model complexity and interpretability, and regulatory expectations for model transparency. Knowledge of interpretability standards across FDA, EMA, and CIOMS frameworks.

Assessment Criteria

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

Related Skills

• Other D08 skills in AI Transparency and Explainability
• Cross-domain integrations per DAG architecture

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