| 摘要 |
The present invention relates to a technique in which an EDC system collects clinical trial data included in electronic healthcare records from an EHR system by using a method for converting electronic healthcare records into clinical trial data, the technique in which the EDC system requests, to the EHR system, the clinical trial data included in the electronic healthcare record, which the EHR system has stored, with queries, receives a response to the request, and stores the clinical trial data in the EDC system without re-input of users, unlike the conventional method in which users of an EDC system directly input even clinical trial data included in electronic healthcare records on an electronic recording paper provided by an EDC system. The EDC and EHR systems of the present invention transmit and receive queries and responses using international standard XML messages so as to request data even when the EDC and EHR systems do not identify the internal data structure of each other. More specifically, the EDC system accesses the EHR system of hospitals which participate in clinical trials, requests, using a QED request message, clinical trial data included in electronic healthcare records having a CCD format to the EHR system, receives, using a QED response message, the result of a searched CCD form, converts the result into an SDTM data set, and stores the SDTM data set in the internal database system of the EDC system. [Reference numerals] (702) Have an EDC system to make an inquiry request;(704) QED request XML form ?;(706) Convert the inquiry into a QED request XML form;(708) Transmit the QED request XML inquiry to an EHR system;(710) Convert the QED request XML inquiry into an EHR DBS inquiry;(712) Have the EHR DBS to precess the converted inquiry and generate the results;(714) CCD XML form ?;(716) Convert the inquiry results into a CCD XML form;(718) Transmit the CCD XML inquiry results to an EDC system;(720) User checked ?;(722) Store the inquiry results in the EDC DBS;(724) Next inquiry ? |
