About This Book
Purpose
There is increasing literature and discussion on the need of the pharmaceutical industry to improve efficiency and reduce costs through the use of centralized monitoring techniques. So-called risk-based monitoring (RBM) makes use of central computerized review of clinical trial data and site metrics to determine if and when clinical sites should receive more extensive quality review through on-site monitoring visits. There are many benefits to RBM beyond cost: Statistical and graphical checks can determine the presence of outliers or unusual patterns in the data, comparisons can be made between sites to assess performance and identify potentially fraudulent data or miscalibrated or faulty equipment, and issues can be ...
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