By name: "KSB-D15-K0008" description: "Commercial and Proprietary Databases: Familiarity with specialty databases including drug safety databases, epidemiological data sources, ..." version: "1.0.0" domain: "D15" domain_name: "Sources of Information" type: "Knowledge" proficiency_level: "L1" bloom_level: "understand" triggers: - "explain commercial and proprietary databases" - "what is commercial and proprietary databases" - "explain commercial and proprietary databases" epa_mapping: "EPA-02, EPA-04" cpa_mapping: "CPA-05, CPA-07" regulatory_refs: "ICH-E2D Sec 3.2, MULTI-LIT-001"
KSB-D15-K0008: Commercial and Proprietary Databases
Overview
Domain: D15 - Sources of Information Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand
Description
Familiarity with specialty databases including drug safety databases, epidemiological data sources, prescription monitoring systems, and commercial analytics platforms, understanding licensing requirements, data quality standards, and integration considerations.
Context
- Major Section: Core Knowledge
- Section: Emerging Digital Information Sources
EPA Mapping
- EPA-02:3004-3005
- EPA-04:3009-3010
CPA Pathway
- CPA-05, CPA-07
Regulatory References
- ICH-E2D Sec 3.2
- MULTI-LIT-001
Instructions
When this skill is activated, Claude should:
- Demonstrate L1 proficiency in commercial and proprietary databases
- Apply understand level cognitive skills to explain the topic
- Reference relevant regulatory guidance (ICH-E2D Sec 3.2, MULTI-LIT-001)
- Connect to related EPAs: EPA-02, EPA-04
Key Competencies
- Familiarity with specialty databases including drug safety databases, epidemiological data sources, prescription monitoring systems, and commercial analytics platforms, understanding licensing requirements, data quality standards, and integration considerations.
Assessment Criteria
- Can explain core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D15 skills in Emerging Digital Information Sources
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31