System and method of standard-compliant electronic case report form design and clinical data set generation
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United States of America Patent
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Mar 27, 2017
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Aug 29, 2016
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Abstract
In a method of standard-compliant electronic case report form (eCRF) design and clinical data set collection, the steps comprise providing a standard specification document. Then, analyzing the standard specification document to generate a standard-compliant question information by a standard specification analyzer, and transforming the standard-compliant question information to a standard-compliant question object by a standard-compliant question generator. Generating a standard-compliant eCRF by a standard-compliant case report form design interface. Moreover, confirming the standard-compliant eCRFs whether comply with the standard specification by a standard rules validator.
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