Patent ID: 9002875
Filing Date: 2015-04-07
Classification: G06F,G16H,G16Z

Abstract:
1. A method of integrating clinical trial data into a form required by a standard, said method comprising: providing a case report form designed to capture specific data needed to test the efficacy of a new agent in a clinical trial; capturing the specific data, wherein the specific data that has been captured is stored in a trial data store and at least a portion of the stored specific data is in a non-compliant format that includes at least one data variable element that varies in at least one of a format, syntax, and semantics; analyzing, by a data mapping processor, the specific data stored that is in the non-compliant format in the trial data store to capture transformation rules capable of converting the at least one variable data element into at least one standards compliant data element that does not vary in format, syntax, and semantics; converting, by the data mapping processor, the specific data that is in the non-compliant format into a standards compliant format, wherein said converting applies said transformation rules that transform the at least one variable data element into the at least one standard data element; validating said standards complaint data to generate validated submission data; and storing said validated submission data in a submission data store.