In August 2011, FDA released a draft guidance document recommending a Risk-Based approach to monitoring. Risk- Based Monitoring combines the vigilance and data surveillance (key features of Electronic Data Capture systems) with traditional on-site data verification targeting critical data points. Rather than a standardized monitoring plan, Risk-Based Monitoring aims to adapt the monitoring plan to the changing needs of the Study, Site and Investigational Product.
With growing interest in Risked-Based Monitoring, President and CEO Sandra Maddock presented an audio conference on September 11, 2012 on Centralized vs. Onsite Monitoring – Applying FDA's Risk-based Approach. The presentation discussed the key principles of the current trends in research monitoring with a focus on the advantages of using a Risk Based Monitoring approach, while touching on topics like:
- An overview of monitoring
- Monitoring regulations and standards
- Current Status of our industry
- FDA’s draft guidance
- Application using various case studies
Also available for review is the whitepaper “Centralized vs. Onsite Monitoring: A Sponsor’s Balancing Act” which acts as a guide to understanding the various aspects of what a monitor does on site, how this affects monitoring, and assessing the risk for onsite and centralized monitoring for a clinical trial.
IMARC Research is committed to being an industry thought leader on a wide-range of clinical research topics. We give periodic presentations throughout the year and welcome you to look through past presentations. If you have any thoughts regarding this presentation, or ideas on a relevant topic for a new one, feel free to share below!
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