SYSTEM AND METHOD FOR ASSESSING SUBJECT EVENT RATE REPORTING
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Dec 10, 2014
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Dec 10, 2014
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Abstract
A system for assessing a clinical trial site's subject event reporting rate includes a subject event and visit count processor and a site subject event rate processor. The subject event and visit count processor receives subject event and subject visit data from a plurality of clinical trial sites and calculates for each clinical trial site a total visit count and a total subject event count. The site subject event rate processor receives the total visit count and total subject event count for each clinical trial site, calculates a trial-level subject event rate for the clinical trial, calculates for each clinical trial site an expected total subject event count based on the clinical trial site's total visit count and the trial-level subject event rate, and compares for each clinical trial site the expected total subject event count to the total subject event count to assess the probability that the clinical trial site is under-reporting or over-reporting subject events.
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