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Approaches to Risk-based Monitoring
Session Chair(s)
Jeffrey S. Handen, PhD
Vice President, Clinical Solutions
Medidata Solutions Worldwide, United States
Ensuring data integrity and patient safety has been interpreted as 100% source document verification (SDV) and onsite monitoring. The 2011 FDA guidance, evidence of less than optimal accuracy of 100% SDV, and very low rates of data correction, all suggest alternate monitoring strategies.
Learning Objective : Discuss real-life case study examples of risk-based monitoring; Describe how to ensure data integrity with reduced expenditures on traditional 100% on-site monitoring and SDV.
Speaker(s)
CRO: Key Success Factors for a Sustainable Risk-based Monitoring Model
Kyle Given
Medidata Solutions Worldwide, United States
Principal, Strategic Consulting Services
Optimizing Data Quality in Clinical Trials: Performance-based Monitoring, Remote Monitoring, Reduced SDV
Vikas Gulati
Vertex Pharmaceuticals, United States
Director, Clinical Data Management
FDA Perspective
Ann Meeker-O'Connell, MS
FDA, United States
Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
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