By name: "KSB-D15-K0004" description: "Clinical Trial Databases: Comprehensive knowledge of clinical trial registries (ClinicalTrials.gov, EudraCT, WHO ICTRP) and re..." version: "1.0.0" domain: "D15" domain_name: "Sources of Information" type: "Knowledge" proficiency_level: "L4" bloom_level: "analyze" triggers: - "explain clinical trial databases" - "what is clinical trial databases" - "analyze clinical trial 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-K0004: Clinical Trial Databases
Overview
Domain: D15 - Sources of Information Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Analyze
Description
Comprehensive knowledge of clinical trial registries (ClinicalTrials.gov, EudraCT, WHO ICTRP) and results databases, understanding trial design information, results reporting requirements, and limitations that influence interpretation of safety data from investigational studies.
Context
- Major Section: Core Knowledge
- Section: Traditional Information Sources and Management
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 L4 proficiency in clinical trial databases
- Apply analyze level cognitive skills to analyze the topic
- Reference relevant regulatory guidance (ICH-E2D Sec 3.2, MULTI-LIT-001)
- Connect to related EPAs: EPA-02, EPA-04
Key Competencies
- Comprehensive knowledge of clinical trial registries (ClinicalTrials.gov, EudraCT, WHO ICTRP) and results databases, understanding trial design information, results reporting requirements, and limitations that influence interpretation of safety data from investigational studies.
Assessment Criteria
- Can analyze core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D15 skills in Traditional Information Sources and Management
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31