ksb-d08-k0005

name: "KSB-D08-K0005" description: "Threshold Management: Statistical significance criteria, clinical significance benchmarks, false discovery rate control, m..." version: "1.0.0" domain: "D08" domain_name: "Signal Detection & Management" type: "Knowledge" proficiency_level: "L3" bloom_level: "apply" triggers: - "explain threshold management" - "what is threshold management" - "apply threshold management" 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-K0005: Threshold Management

Overview

Domain: D08 - Signal Detection & Management Type: Knowledge Proficiency Level: L3 (Competent - Minimal supervision) Bloom Level: Apply

Description

Statistical significance criteria, clinical significance benchmarks, false discovery rate control, multiple testing correction methods

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

• CPA-02

Regulatory References

• FDA-GUID-006
• EMA-GVP-005
• EMA-GVP-010
• CIOMS-VIII

Instructions

When this skill is activated, Claude should:

1. Demonstrate L3 proficiency in threshold management
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (FDA-GUID-006, EMA-GVP-005, EMA-GVP-010, CIOMS-VIII)
4. Connect to related EPAs: EPA-04, EPA-05

Key Competencies

• Statistical significance criteria, clinical significance benchmarks, false discovery rate control, multiple testing correction methods

Assessment Criteria

• Can apply 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