quality risk radar - clinical risk based monitoring technology, randy ramin-wright, clinerion
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Quality Risk Radar
Clinical Risk Based Monitoring Technology
June 2015
Randy Ramin-Wright
Head of Quality Risk Management
Email: [email protected]
This document is confidential and is intended solely for the use and information of the persons to whom it is addressed. Without the consent of Clinerion neither concept nor individual information from this document may be reproduced or passed on to third parties.
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What is the Quality Risk Radar (QRR)?
• Provides Decision Support
• Helps steer Clinical Processes Surveillance System
• Increases Quality • Reduces Risk • Promotes Patient Safety • Facilitates Data Integrity
Support Process
• Study Quality Risk Assessment
• Trial Site Risk Assessment
• Risk Mitigation Tool System Modules
• Study Quality Management
• Risk-based Monitoring
• Vendor Oversight (and others)
Application Areas
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Quality Risk Categories of Quality Risk Radar
• Protocol Design
• Study Setup Study
• Medical
• Monitoring
• Protocol Adherence
• Data Management
• Patient Recruitment
Site
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Risk-based Study Quality Management Process
Review & Adapt
System and Process
(1)
Integrate Risk Data
(2)
Calculate Risk
(3)
Report Risk
(4)
Adapt Plan
(5)
Control Risk
Iterative and Adaptive
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(1) Integrate Risk Data
CTMS
CTMS 1
CTMS 2
EDC
EDC 1
EDC 2
Safety
Safety 1
Safety 2
Data Integration Service Quality Risk Radar
Web Services
ODS
ETL
ETL
Web Services
QRR Questionnaire
DB
Risk Calculation
Risk Control
RPN
KRIs
BRP
Reports
Tasks/Plans
Notifications
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Study Quality Risk Assessment Questionnaire
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KRI Values & Signals
(2) Calculate Risk - QRR Risk Calculation Model
Impact
Detectability
Likelihood
x
x
KRI
KRI
KRI
Risk = RPN
Key Risk Indicator (KRI) Calculation
Risk Priority Number (RPN)
KRI KRI
KRI
Base Risk Profile (BRP)
Calculation
BRP measures Structural Risk KRIs evaluate Process Risks
RPN is derived from the BRP and KRIs
RPN is the key output for each Risk Assessment
RPN enables comparison between Risk Entities (e.g. studies, trial sites)
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(3) Report Risk – Site Risk Assessment Overview
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(4) Adapt Plan – Risk-based Monitoring Plan
Review and Adapt
Monitoring Plan
Proposal
Implement and Track
Monitoring Plan
Technology
Central Monitor Site Monitor
Central Monitor Study Management Team
Cross-functional QRM Team
Monitoring Plan Proposal
Review Results
Derive Improvements
Central Monitor Study Management Team
Cross-functional QRM Team
Process People
Risk Mitigation
Tool
Study and Site
Quality
Risk Assess-ments
Integrate Risk Data
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Capture root cause analysis result
(5) Control Risk – Targeted Monitoring
Document the risk mitigation
Track Progress of Risk Interventions
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Quality Risk Radar Demo
Clinerion Ltd. Margarethenstrasse 47 4053 Basel, Switzerland
Phone: +41 61 865 60 60 Fax: +41 61 865 60 61
Web: www.clinerion.com
This document is confidential and is intended solely for the use and information of the persons to whom it is addressed Without the consent of Clinerion neither concept nor individual information from this document may be reproduced or passed on to third parties.