Open Access Update

Revising the ECRIN standard requirements for information technology and data management in clinical trials

Christian Ohmann1*, Steve Canham2, Catherine Cornu3, Jochen Dreß4, François Gueyffier5, Wolfgang Kuchinke1, Enrico B Nicolis6 and Michael Wittenberg7

Author Affiliations

1 Coordination Centre for Clinical Trials, Heinrich Heine University, Moorenstrasse 5, 40225, Düsseldorf, Germany

2 Independent consultant, c/o Coordination Centre for Clinical Trials, Heinrich Heine University, Moorenstrasse 5, 40225, Düsseldorf, Germany

3 INSERM, CIC201; CHU Lyon, Service de Pharmacologie Clinique, Université de Lyon, UMR 5558, 69000, Lyon, France

4 Centre for Clinical Studies (ZKS), University of Cologne, Gleueler Strasse 269, 50935, Köln, Germany

5 Service de Pharmacologie Clinique et Essais Thérapeutiques, Hospices Civils de Lyon, Faculté de Médecine Laennec, 7 rue Guillaume Paradin, 69376, Lyon France

6 Department of Cardiovascular Research, Mario Negri Institute- IRCCS, via la Masa 19, 20156, Milan, Italy

7 Coordination Centre for Clinical Trials, Philipps University Marburg, Biegenstrasse 10, 35032, Marburg, Germany

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Trials 2013, 14:97  doi:10.1186/1745-6215-14-97

Published: 5 April 2013

Abstract

The pilot phase of the ECRIN (European Clinical Research Infrastructure Network) certification programme for European data centres, in late 2011, led to a substantial revision of the original ECRIN standards, completed by June 2012. The pilot phase, the conclusions drawn from it and the revised set of standards are described. Issues concerning the further development of standards and related material are discussed, as are the methods available to best support that development. A strategy is outlined based on short-lived specific task groups, established as necessary by a steering group drawn from ECRIN-ERIC. A final section discusses possible future developments.

Keywords:
Standards; Information technology; Data management; ECRIN; European; Certification