期刊名称：International Journal of Computer Science & Information Technology (IJCSIT)
印刷版ISSN：0975-4660
电子版ISSN：0975-3826
出版年度：2012
卷号：4
期号：6
页码：11
出版社：Academy & Industry Research Collaboration Center (AIRCC)
摘要：The demand of transparency of clinical research results, the need of accelerating the process oftransferring innovation in the daily medical practice as well as assuring patient safety and product efficacymake it necessary to extend the functionality of traditional trial registries. These new systems shouldcombine different functionalities to track the information exchange, support collaborative work, manageregulatory documents and monitor the entire clinical investigation (CIV) lifecycle. This is the approachused to develop MEDIS, a Medical Device Information System, described in this paper under theperspective of the business process, and the underlining architecture. Moreover, MEDIS was designed onthe basis of Health Level 7 (HL7) v.3 standards and methodology to make it interoperable with similarregistries, but also to facilitate information exchange between different health information systems.
关键词：Clinical trial business process; Medical devices; System architecture; Data model; Trial registry.
