Abstract
Clinical research and routine care documentation have traditionally been performed in a dual-source approach, where data is collected redundantly and maintained in separated systems. The generic x4T single-source process removes redundant steps and is adoptable to specific types of studies. In support of the various processes, we have designed and implemented an architecture called x4T based on CDISC ODM. The software has been deployed in three different use cases containing up to 3976 subjects until now and allows real-time access to live data from routine care documentation systems.
About the authors
Department of Information Systems, University of Münster, Leondardo-Campus 3, 48149 Münster, Germany
Institute of Medical Informatics, University of Münster, Albert-Schweitzer-Campus 1, Gebäude A11, 48149 Münster, Germany, Tel.: +49-251-8358380
Department of Information Systems, University of Münster, Leondardo-Campus 3, 48149 Münster, Germany, Tel.: +49-251-8338158
Faculty of Health Care, Niederrhein University of Applied Sciences, Reinarzstraße 49, 47805 Krefeld, Germany, Tel.: +49-2151-8226655
Department of Information Systems, University of Münster, Leondardo-Campus 3, 48149 Münster, Germany, Tel.: +49-251-8338151, and Department of Management Systems, The University of Waikato, Private Bag 3105, Hamilton, New Zealand
©2015 Walter de Gruyter Berlin/Boston
