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Get Free AccessBecause the considerable heterogeneity of data management software solutions may be a hindrance to cooperation based on trial data exchange, standards like CDISC (Clinical Data Interchange Standard Consortium) should be implemented more widely. In a heterogeneous environment the use of data standards can simplify data exchange, increase the quality of data and prepare centres for new developments (e.g. the use of EHR for clinical research). Because data management and the use of electronic data capture systems in clinical trials are characterized by the impact of regulations and guidelines, ethical concerns are discussed. In this context quality management becomes an important part of compliant data management. To address these issues ECRIN will establish certified data centres to support electronic data management and associated compliance needs of clinical trial centres in Europe.
Wolfgang Kuchinke, Christian Ohmann, Qin Yang, Nader Salas, Jens Lauritsen, François Gueyffier, Alan Leizorovicz, Carmen Schade‐Brittinger, Michael Wittenberg, Zoltán Vokó, Siobhán Gaynor, Margaret Cooney, Peter Doran, Aldo Maggioni, Andrea Lorimer, Ferrán Torres, Gladys McPherson, Jim Charwill, Mats Hellström, Stéphane Lejeune (2010). Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres. , 11(1), DOI: https://doi.org/10.1186/1745-6215-11-79.
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Type
Article
Year
2010
Authors
20
Datasets
0
Total Files
0
Language
en
DOI
https://doi.org/10.1186/1745-6215-11-79
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