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Open Access 01-12-2013 | Update

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

Authors: Christian Ohmann, Steve Canham, Catherine Cornu, Jochen Dreß, François Gueyffier, Wolfgang Kuchinke, Enrico B Nicolis, Michael Wittenberg

Published in: Trials | Issue 1/2013

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.

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Ohmann C, Kuchinke W, Canham S, Lauritsen J, Salas N, Schade-Brittinger C, Wittenberg M, McPherson G, McCourt J, Gueyffier F, Lorimer A, Torres F: ECRIN Working Group on Data Centres: Standard requirements for GCP-compliant data management in multinational clinical trials. Trials. 2011, 12: 85-10.1186/1745-6215-12-85. Additional file 1: Version 1 from 27 May 2010 developed by the European Clinical Research Infrastructures Network (ECRIN) Working Group on Data Centres. [Available at http://www.trialsjournal.com/content/12/1/85/additional]CrossRefPubMedPubMedCentral

Ohmann C, Kuchinke W, Canham S, Lauritsen J, Salas N, Schade-Brittinger C, Wittenberg M, McPherson G, McCourt J, Gueyffier F, Lorimer A, Torres F: ECRIN Working Group on Data Centres: Standard requirements for GCP-compliant data management in multinational clinical trials. Trials. 2011, 12: 85-10.1186/1745-6215-12-85. [Available at http://www.trialsjournal.com/content/12/1/85]CrossRefPubMedPubMedCentral

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Title: Revising the ECRIN standard requirements for information technology and data management in clinical trials
Authors: Christian Ohmann
Steve Canham
Catherine Cornu
Jochen Dreß
François Gueyffier
Wolfgang Kuchinke
Enrico B Nicolis
Michael Wittenberg
Publication date: 01-12-2013
Publisher: BioMed Central
Published in: Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/1745-6215-14-97

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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