Experience Conducting Studies with Risk Based Monitoring Strategies
Nycole Olivo
Wednesday, July 9, 2014
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Chapters
Introduction
Disclaimer
Planning and Implementing RBM Strategies is a Complex Process
Complex Planning and Continuous Assessment
RBM Planning and Continuous Assessment
Quality is Enhanced by RBM
Inspection readiness
Investigator Portal
Investigator Portal Ensures Training Compliance
Investigator Portal Reduces Protocol Deviations
Quality and Efficiency Gains Through Risk Based Monitoring Plans
Analytics Platform Aggregates Data for Real Time Access
Methodology Developed to Detect Risk Through Central Monitoring
Medical Safety Signal Detection Through Central Monitoring
Site Quality Signal Detection Through Central Monitoring
Quality and Risk Reviews Maintain Continuous and Iterative Oversight
Process to Identify Risks and Mitigate Errors
Case Study 1
Case Study 2
Case Study 3
Case Study 4
Key Elements for Delivering Quality Studies Using RBM Strategies
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