| 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
Regulatory References
Instructions
When this skill is activated, Claude should:
- Demonstrate L5 proficiency in federated learning for multi-site studies
- Apply evaluate level cognitive skills to evaluate the topic
- Reference relevant regulatory guidance (general PV standards)
- 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
Generated from PV KSB Framework v1.0 | 2025-12-31
