DIA 48th Annual Meeting
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Understanding Risk-based Monitoring: Is It Art, Science, or Both?
Track : Track 01: Clinical Operations
Program Code: 215
Date: Tuesday, June 26, 2012
Time: 10:00 AM to 11:30 AM  EST
 Kathleen Findlen, Collegium Pharmaceutical, United States
 Jennifer Stier, Medidata Solutions Worldwide, United States
 Edward Seguine, Clinical Ink, United States
Andrew Roberts, Novartis Institutes for BioMedical Research, Switzerland
 Steve Shevel, Waife & Associates Inc, United States
FDA has recently issued two important and related draft guidance documents covering electronic source and risk-based monitoring. FDA now clearly expects sponsors to take better advantage of electronic data capture (EDC) technology by implementing a targeted, risk-based approach to monitoring data remotely. Targeted source document verification (SDV) can be a highly effective and low-cost method of implementing an innovative monitoring strategy where 100% monitoring of site data is costly and not needed. Yet, in light of these potential cost savings, targeted SDV is still more of a frequent discussion topic rather than a reality. This symposium will provide perspectives on how this guidance could change the day-to-day relationships of sites/sponsors/monitors.

Learning Objectives:
Discuss FDA's Draft Guidance documents on electronic source and risk-based monitoring
Identify the issues decision makers must consider when implementing targeted source document verification (SDV), including the factors needed to calculate a detailed return on investment (ROI)
Recognize the operational impact of risk-based monitoring on sites/sponsors/monitors.