DISTRIBUTED RANDOMIZATION AND SUPPLY MANAGEMENT IN CLINICAL TRIALS
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United States of America Patent
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app pub date -
Apr 16, 2014
filing date -
Jun 12, 2010
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Abstract
A distributed clinical trial system that provides configurability, reusability and integration of randomization for different clinical trials with various electronic data capture (EDC) systems. The distributed clinical trial system includes a method of randomizing subjects in a multi-arm clinical trial. In accordance with a method, a subject identifier and a trial identifier are received from an EDC system. The trial identifier indicates the multi-arm clinical trial and the subject identifier indicates a subject enrolled in the multi-arm clinical trial. A randomization design algorithm for the multi-arm clinical trial is retrieved from a database using the received trial identifier. The randomization design algorithm is executed. The randomization design algorithm randomizes the subject to an arm of the multi-arm clinical trial, assigning the subject identifier to an arm identifier that indicates the arm of the multi-arm clinical trial to which the subject has been randomized
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