| name | KSB-D08-K0009 |
| description | Time-to-Event Analysis: Survival analysis applications, Cox proportional hazards modeling, competing risks analysis, recurre... |
| version | 1.0.0 |
| domain | D08 |
| domain_name | Signal Detection & Management |
| type | Knowledge |
| proficiency_level | L4 |
| bloom_level | analyze |
| triggers | ["explain time-to-event analysis","what is time-to-event analysis","analyze time-to-event analysis"] |
| 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-K0009: Time-to-Event Analysis
Overview
Domain: D08 - Signal Detection & Management
Type: Knowledge
Proficiency Level: L4 (Proficient - Independent practice)
Bloom Level: Analyze
Description
Survival analysis applications, Cox proportional hazards modeling, competing risks analysis, recurrent event methodology
Context
- Major Section: Signal Detection Theoretical Foundation and Methodological Framework
- Section: Traditional Statistical Detection Methodologies
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 L4 proficiency in time-to-event analysis
- Apply analyze level cognitive skills to analyze 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
- Survival analysis applications, Cox proportional hazards modeling, competing risks analysis, recurrent event methodology
Assessment Criteria
- Can analyze core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D08 skills in Traditional Statistical Detection Methodologies
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31
