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TERMTrial--terminology-based documentation systems for cooperative clinical trials.

Authors
  • Merzweiler, A1
  • Weber, R
  • Garde, S
  • Haux, R
  • Knaup-Gregori, P
  • 1 University of Heidelberg, Institute for Medical Biometry and Informatics, Department of Medical Informatics, Heidelberg, Germany. , (Germany)
Type
Published Article
Journal
Computer Methods and Programs in Biomedicine
Publisher
Elsevier
Publication Date
Apr 01, 2005
Volume
78
Issue
1
Pages
11–24
Identifiers
PMID: 15780886
Source
Medline
License
Unknown

Abstract

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 terminology-based interactive design of electronic case report forms (eCRFs). TERMTrial combines the advantages of remote data entry with a comprehensive terminological control.

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