TERMTrial-terminology-based documentation systems for cooperative clinical trials

  • Authors:

  • A. Merzweiler;R. Weber;S. Garde;R. Haux;P. Knaup-Gregori

  • Affiliations:

  • University of Heidelberg, Institute for Medical Biometry and Informatics, Department of Medical Informatics, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany;University of Heidelberg, Coordination Center for Clincial Trials, Im Neuenheimer Feld 221, 69120 Heidelberg, Germany;Central Queensland University, Health Informatics Research Group, Faculty of Informatics and Communication, Rockhampton Qld 4702, Australia;Technical University of Braunschweig, Institute for Medical Informatics, Muehlenpfordtstr. 23, 38106 Braunschweig, Germany;University of Heidelberg, Institute for Medical Biometry and Informatics, Department of Medical Informatics, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany

  • Venue:
  • Computer Methods and Programs in Biomedicine
  • Year:
  • 2005

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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.