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


Abstract
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.

Keywords
Information Systems. Program Evaluation. Health Level Seven. Medical Informatics. Multicenter Studies as Topic. Reproducibility of Results. Documentation. Systems Integration. Software. Medical Records Systems Computerized. Biomedical Research. Hospital Information Systems. Research Design. Program Development. Humans, . Information Systems. Program Evaluation. Health Level Seven. Medical Informatics. Multicenter Studies as Topic. Reproducibility of Results. Documentation. Systems Integration. Software. Medical Records Systems Computerized. Biomedical Research. Hospital Information Systems. Research Design. Program Development. Humans



Publication type
Conference paper

Peer reviewed
Yes

Publication status
Published

Year
2011

Conference
International Conference of the European Federation for Medical Informatics (MIE 2011)

Venue
Oslo, Norway

Book title
User Centred Networked Health Care - Proceedings of MIE 2011

Editor
Moen Anne, Andersen Stig Kjær, Aarts Jos, Hurlen Petter

Start page
902

End page
906

Volume
169

Title of series
Studies in Health Technology and Informatics

Publisher
IOS Press

Language
English

ISBN
978-1-60750-805-2

DOI