By name: "KSB-D09-K0020" description: "Sensitivity Analysis Framework: Bias parameter quantification, probabilistic bias analysis, Monte Carlo sensitivity assessment, thre..." version: "1.0.0" domain: "D09" domain_name: "Post-Authorization Studies" type: "Knowledge" proficiency_level: "L1" bloom_level: "remember" triggers: - "explain sensitivity analysis framework" - "what is sensitivity analysis framework" - "define sensitivity analysis framework" epa_mapping: "EPA-02, EPA-04, EPA-05" cpa_mapping: "CPA-02, CPA-07" regulatory_refs: "FDA-STAT-001, FDA-CFR-006, EMA-GVP-009"
KSB-D09-K0020: Sensitivity Analysis Framework
Overview
Domain: D09 - Post-Authorization Studies Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Remember
Description
Bias parameter quantification, probabilistic bias analysis, Monte Carlo sensitivity assessment, threshold analysis methodologies
Context
- Major Section: Post-Authorization Study Design Framework and Methodological Foundation
- Section: Bias Assessment and Control Strategies
EPA Mapping
- EPA-02:3004-3005
- EPA-04:3009-3010
- EPA-05:3011-3012
CPA Pathway
- CPA-02, CPA-07
Regulatory References
- FDA-STAT-001
- FDA-CFR-006
- EMA-GVP-009
Instructions
When this skill is activated, Claude should:
- Demonstrate L1 proficiency in sensitivity analysis framework
- Apply remember level cognitive skills to define the topic
- Reference relevant regulatory guidance (FDA-STAT-001, FDA-CFR-006, EMA-GVP-009)
- Connect to related EPAs: EPA-02, EPA-04, EPA-05
Key Competencies
- Bias parameter quantification, probabilistic bias analysis, Monte Carlo sensitivity assessment, threshold analysis methodologies
Assessment Criteria
- Can define core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D09 skills in Bias Assessment and Control Strategies
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31