| name | KSB-D08-K0001 |
| description | Signal Conceptual Framework: New safety information arising from one or multiple sources suggesting new causal associations or ne... |
| version | 1.0.0 |
| domain | D08 |
| domain_name | Signal Detection & Management |
| type | Knowledge |
| proficiency_level | L2 |
| bloom_level | understand |
| triggers | ["explain signal conceptual framework","what is signal conceptual framework","explain signal conceptual framework"] |
| 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-K0001: Signal Conceptual Framework
Overview
Domain: D08 - Signal Detection & Management
Type: Knowledge
Proficiency Level: L2 (Advanced Beginner - Indirect supervision)
Bloom Level: Understand
Description
New safety information arising from one or multiple sources suggesting new causal associations or new aspects of known associations, risk characterization principles, strength of evidence evaluation
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 conceptual framework
- 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
- New safety information arising from one or multiple sources suggesting new causal associations or new aspects of known associations, risk characterization principles, strength of evidence evaluation
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
