The Single Source Architecture x4T to Connect Medical Documentation and Clinical Research
Dziuballe Philipp, Forster Christian, Breil Bernhard, Thiemann Volker, Fritz Fleur, Lechtenbörger Jens, Vossen Gottfried, Dugas Martin
Research article in edited proceedings (conference) | Peer reviewedAbstract
Clinical trials often require large and redundant documentation efforts, because information systems in patient care and research are separated. In two clinical trials we have assessed the number of study items available in the clinical information system for re-use in clinical research. We have analysed common standards such as HL7, IHE RFD and CDISC ODM, regulatory constraints and the documentation process. Based on this analysis we have designed and implemented an architecture for an integrated clinical trial documentation workflow. Key aspects are the re-use of existing medical routine data and the integration into current documentation workflows.
Details about the publication
Authors from the University of Münster
| Bruland, Philipp | Institute of Medical Informatics |
| Dugas, Martin | Institute of Medical Informatics |
| Forster, Christian | Databases and Information Systems Group (DBIS) |
| Lechtenbörger, Jens | Databases and Information Systems Group (DBIS) |
| Vossen, Gottfried | Databases and Information Systems Group (DBIS) |