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Session 0408: CLINICAL DATA MANAGEMENT (CDM) ROLE IN THE RISK-BASED APPROACH TO MONITORING
Session Chair(s)
Andrew Taylor
Director Data Management
GCE Solutions, United Kingdom
The Risk-Based Monitoring Approach makes use of central computerized review of clinical trial data and site metrics to determine if sites should receive more extensive quality review through onsite monitoring visits. This approach has a broad impact on almost all facets of clinical trial management, including people, process and technology as well as the quality and integrity of clinical data. What kind of challenges will this pose to data managers? What new role, responsibilities and skill sets will be needed for data managers to provide value in this approach? The speakers in this session will discuss real-life case study examples of risk-based monitoring and describe how to ensure data integrity with reduced expenditures on traditional 100% on-site monitoring and SDV from data manager perspective.
Speaker(s)
Data Management Approach in Risk Based Monitoring
Andrew Taylor
GCE Solutions, United Kingdom
Director Data Management
Late Phase Centralized Site Management - an Integrated Approach Toward Risk-Based Monitoring
Hady Khoury, MD
Medable, United States
Chief Development Officer
Risk Based Monitoring: A case study from initiation to completion
Carina Reinicke
Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
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