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CLINICAL TRIAL OVERSIGHT AND IDENTIFICATION OF ERRORS IN CLINICAL TRIAL PROCEDURE
CLINICAL TRIAL OVERSIGHT AND IDENTIFICATION OF ERRORS IN CLINICAL TRIAL PROCEDURE
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机译：临床试验的监督和临床试验程序中错误的识别
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摘要
Deviations from a clinical trial protocol are identified based on automated analysis of clinical trial data. Clinical trial data can be collected for subjects or investigators at multiple study sites using any number of systems or collection methods. The types of data to be analyzed can be defined by identifying aspects of conducting a clinical trial which are imperative to maintaining integrity of the clinical trial data. Rules can be defined based on the identified critical aspects to establish criteria to be satisfied to ensure that the clinical trial has been conducted according to the protocol. A cross-database analysis of clinical trial data is performed to determine whether deviations have occurred. Deviations are logged for subsequent analysis to determine whether the deviation is part of a greater trend in errors. The associated clinical trial data can be further evaluated and the clinical trial workflow directed to address the identified errors.
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