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63. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e. V. (GMDS)

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie

02. - 06.09.2018, Osnabrück

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Using open source CDM software for retrospective quality assessment and data management in clinical trials

Meeting Abstract

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  • Peter Krüger - Institut für Forschung in der Operativen Medizin (IFOM), Köln, Deutschland
  • Christa Raak - Universität Witten/Herdecke, Herdecke, Deutschland
  • Thomas Ostermann - Department for Psychology and Psychotherapy, Witten/Herdecke University, Witten, Deutschland

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie. 63. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS). Osnabrück, 02.-06.09.2018. Düsseldorf: German Medical Science GMS Publishing House; 2018. DocAbstr. 53

doi: 10.3205/18gmds053, urn:nbn:de:0183-18gmds0534

Published: August 27, 2018

© 2018 Krüger et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.

Outline

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Globalization is one of the most important aspects influencing almost all national healthcare systems in the 21st century. In particular in the field of clinical trials and pharmaceutical research globalization has become a core issue of business models raising important questions about the accuracy, quality and validity of the results of trials conducted in a variety of national settings. This article describes the use of open source Clinical Data Management (CDM) software for quality assessment and management of a clinical trial data from Russia using programmed validation checks. The procedure described illustrates a special case in which the data of a previously performed clinical study were complemented by an assessment of data quality and coherence. Although the procedure described should not be regarded as a way to circumvent clinical monitoring and query management of original data, it illustrates how a retrospective quality management of clinical data can support their analysis thereafter.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.