Accumulation of Photographic Image Data using an EDC System in a Post-Marketing Study of Contrast Medium

Abstract

 Authors have developed the EDC (Electronic Data Capture) system for a post-marketing study of contrast medium in which both of patients' information and computerized tomography images (CT images) of DICOM (Digital Imaging and Communications in Medicine) standard can be collected and managed. The flow of CT images in the EDC system was as follows. The investigators transmitted CT images from each institutions to doctors at Kagawa University Hospital (image supervisory office) through the telemedicine network system (K–MIX) which combined EDC system. Private information of the patients on the DICOM tag data of CT images were masked by doctors at image supervisory office, then the CT images were uploaded to the data server of EDC system. And the CT images were downloaded from the data server by pharmaceutical industry, and used in a central review for the efficacy evaluation of the contrast medium.
 The newly developed EDC system for this study is enable collection of CT images combined with the patients' information and integrative management of two types of data under the condition that both of security and authenticity of the data could be maintained, and also it is indicated that those collecting data can be used efficiently for the efficacy evaluation in a post-marketing study. Moreover, we thought that the EDC system will be a model case of collection method of image data for incidental utilization in a post-marketing study.