ksb-d09-k0106

name	KSB-D09-K0106
description	Federated Learning for Multi-Site Studies: Mastery of federated learning approaches for multi-site pharmacovigilance studies including privacy-...
version	1.0.0
domain	D09
domain_name	Post-Authorization Studies
type	Knowledge
proficiency_level	L5
bloom_level	evaluate
triggers	["explain federated learning for multi-site studies","what is federated learning for multi-site studies","evaluate federated learning for multi-site studies"]
epa_mapping	EPA-02, EPA-04, EPA-05
cpa_mapping	CPA-02, CPA-07
regulatory_refs

KSB-D09-K0106: Federated Learning for Multi-Site Studies

Overview

Domain: D09 - Post-Authorization Studies Type: Knowledge Proficiency Level: L5 (Expert - Can supervise others) Bloom Level: Evaluate

Description

Mastery of federated learning approaches for multi-site pharmacovigilance studies including privacy-preserving distributed analytics, secure multi-party computation, collaborative model training, and federated signal detection methods.

Context

• Major Section: AI in Post-Authorization Studies
• Section: Federated Learning PV

EPA Mapping

• EPA-02:3004-3005
• EPA-04:3009-3010
• EPA-05:3011-3012

CPA Pathway

• CPA-02, CPA-07

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L5 proficiency in federated learning for multi-site studies
2. Apply evaluate level cognitive skills to evaluate the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-02, EPA-04, EPA-05

Key Competencies

• Mastery of federated learning approaches for multi-site pharmacovigilance studies including privacy-preserving distributed analytics, secure multi-party computation, collaborative model training, and federated signal detection methods.

Assessment Criteria

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

Related Skills

• Other D09 skills in Federated Learning PV
• Cross-domain integrations per DAG architecture

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