| 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
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