ksb-d08-k0001

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

• 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 L2 proficiency in signal conceptual framework
2. Apply understand level cognitive skills to explain 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

• 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

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Generated from PV KSB Framework v1.0 | 2025-12-31