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In a two-part series, this first paper outlines the quality and regulatory thinking that underpins RBQM, and details essential points of compliance...
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ACRO Releases New Report on the Past, Present, and Future of Risk-Based Monitoring Risk-based monitoring (RBM) is a powerful tool for efficiently ensuring patient safety and data integrity in a clinical trial, enhancing overall trial quality. To better understand implementation across the industry, the Association of Clinical Research Organizations (ACRO) conducted a landscape survey of RBM implementation across 6,513 clinical trials that were ongoing in 2019 and compiled the information in a comprehensive report. After an unprecedented year, the clinical research industry has proved innovati...