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TERMtrial : terminology-based documentation systems for cooperative clinical trials

journal contribution
posted on 06.12.2017, 00:00 by A Merzweiler, P Knaup, Sebastian GardeSebastian Garde, R Haux, R Weber
Within cooperative groups of multi-center clinical trials a standardized documentation is a prerequisite for communication and sharing of data. Standardizing documentation systems means standardizing the underlying terminology. The management and consistent application of terminology systems is a difficult and fault-prone task, which should be supported by appropriate software tools. Today, documentation systems for clinical trials are often implemented as so-called Remote-Data-Entry-Systems (RDE-systems). Although there are many commercial systems, which support the development of RDE-systems there is none offering a comprehensive terminological support. Therefore, we developed the software system TERMTrial which consists of a component for the definition and management of terminology systems for cooperative groups of clinical trials and two components for the terminology-based automatic generation of trial databases and terminologybased interactive design of electronic case report forms (eCRFs). TERMTrial combines the advantages of remote data entry with a comprehensive terminological control.

Funding

Category 1 - Australian Competitive Grants (this includes ARC, NHMRC)

History

Volume

78

Issue

1

Start Page

11

End Page

24

Number of Pages

14

ISSN

0169-2607

Location

Ireland

Publisher

Elsevier

Language

en-aus

Peer Reviewed

Yes

Open Access

No

External Author Affiliations

Faculty of Informatics and Communication; TBA Research Institute; Technische Universitat Braunschweig; Universität Heidelberg;

Era Eligible

Yes

Journal

Computer methods and programs in biomedicine.