| name | KSB-D08-K0002 |
| description | Signal Type Classifications: Statistical signals from disproportionality analysis, clinical signals from case series analysis, li... |
| version | 1.0.0 |
| domain | D08 |
| domain_name | Signal Detection & Management |
| type | Knowledge |
| proficiency_level | L2 |
| bloom_level | understand |
| triggers | ["explain signal type classifications","what is signal type classifications","explain signal type classifications"] |
| epa_mapping | EPA-04, EPA-05 |
| cpa_mapping | CPA-02 |
| regulatory_refs | FDA-GUID-006, EMA-GVP-005, EMA-GVP-010, CIOMS-VIII |
KSB-D08-K0002: Signal Type Classifications
Overview
Domain: D08 - Signal Detection & Management
Type: Knowledge
Proficiency Level: L2 (Advanced Beginner - Indirect supervision)
Bloom Level: Understand
Description
Statistical signals from disproportionality analysis, clinical signals from case series analysis, literature signals from published evidence, regulatory signals from authority communications
Context
- Major Section: Signal Detection Theoretical Foundation and Methodological Framework
- Section: Signal Definition and Classification Systems
EPA Mapping
- EPA-04:3009-3010
- EPA-05:3011-3012
CPA Pathway
Regulatory References
- FDA-GUID-006
- EMA-GVP-005
- EMA-GVP-010
- CIOMS-VIII
Instructions
When this skill is activated, Claude should:
- Demonstrate L2 proficiency in signal type classifications
- Apply understand level cognitive skills to explain the topic
- Reference relevant regulatory guidance (FDA-GUID-006, EMA-GVP-005, EMA-GVP-010, CIOMS-VIII)
- Connect to related EPAs: EPA-04, EPA-05
Key Competencies
- Statistical signals from disproportionality analysis, clinical signals from case series analysis, literature signals from published evidence, regulatory signals from authority communications
Assessment Criteria
- Can explain core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D08 skills in Signal Definition and Classification Systems
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31
