ksb-d08-k0023

name	KSB-D08-K0023
description	Signal Validation Automation: Evidence synthesis algorithms, causality assessment support systems, Bradford Hill criteria automate...
version	1.0.0
domain	D08
domain_name	Signal Detection & Management
type	Knowledge
proficiency_level	L4
bloom_level	evaluate
triggers	["explain signal validation automation","what is signal validation automation","evaluate signal validation automation"]
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-K0023: Signal Validation Automation

Overview

Domain: D08 - Signal Detection & Management Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Evaluate

Description

Evidence synthesis algorithms, causality assessment support systems, Bradford Hill criteria automated evaluation

Context

• Major Section: Multi-Source Data Integration and Intelligence Synthesis
• Section: AI-Enhanced Data Quality and Signal Validation

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 L4 proficiency in signal validation automation
2. Apply evaluate level cognitive skills to evaluate 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

• Evidence synthesis algorithms, causality assessment support systems, Bradford Hill criteria automated evaluation

Assessment Criteria

• Can evaluate core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D08 skills in AI-Enhanced Data Quality and Signal Validation
• Cross-domain integrations per DAG architecture

---

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