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


Zusammenfassung
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.

Schlüsselwörter
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



Publikationstyp
Forschungsartikel in Sammelband (Konferenz)

Begutachtet
Ja

Publikationsstatus
Veröffentlicht

Jahr
2011

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

Konferenzort
Oslo, Norway

Buchtitel
User Centred Networked Health Care - Proceedings of MIE 2011

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

Erste Seite
902

Letzte Seite
906

Band
169

Reihe
Studies in Health Technology and Informatics

Verlag
IOS Press

Sprache
Englisch

ISBN
978-1-60750-805-2

DOI