Pulling the Trigger on Risk-based Monitoring
Site monitoring is an essential element of clinical trials, ensuring quality and integrity of a clinical investigation. Monitoring uncovers potential problems, such as data entry errors or missing data, assures that study documentation exists, assesses the familiarity of the site’s staff with the protocol and required procedures, and provides a sense of the overall quality of a site. Rick Morrison at Comprehend Systems discusses how risk-based approach to site monitoring can reduce overall costs by more than 20 per cent in a large Phase III trial, and reduced SDV could potentially save the industry billions of dollars per year.
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