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

Trials

Michael Wittenberg⁵  Enrico B Nicolis⁷  Wolfgang Kuchinke⁴  François Gueyffier⁶  Jochen Dreß¹  Catherine Cornu²  Steve Canham³  Christian Ohmann⁴ 

[1] Centre for Clinical Studies (ZKS), University of Cologne, Gleueler Strasse 269, 50935, Köln, Germany;INSERM, CIC201; CHU Lyon, Service de Pharmacologie Clinique, Université de Lyon, UMR 5558, 69000, Lyon, France;Independent consultant, c/o Coordination Centre for Clinical Trials, Heinrich Heine University, Moorenstrasse 5, 40225, Düsseldorf, Germany;Coordination Centre for Clinical Trials, Heinrich Heine University, Moorenstrasse 5, 40225, Düsseldorf, Germany;Coordination Centre for Clinical Trials, Philipps University Marburg, Biegenstrasse 10, 35032, Marburg, Germany;Service de Pharmacologie Clinique et Essais Thérapeutiques, Hospices Civils de Lyon, Faculté de Médecine Laennec, 7 rue Guillaume Paradin, 69376, Lyon France;Department of Cardiovascular Research, Mario Negri Institute- IRCCS, via la Masa 19, 20156, Milan, Italy

关键词: Certification;    European;    ECRIN;    Data management;    Information technology;    Standards;   

Others  :  1094343
DOI  :  10.1186/1745-6215-14-97

 received in 2012-09-03, accepted in 2013-03-08,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Ohmann et al.; licensee BioMed Central Ltd.

【 图 表 】

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【 参考文献 】

• [1]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. 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 webcite] BioMed Central Full Text
• [2]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. [Available at http://www.trialsjournal.com/content/12/1/85 webcite] BioMed Central Full Text
• [3]Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG: for the CONSORT Group: CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trial. J Clin Epi 2010, 63:1-37. [Available at http://www.consort-statement.org/consort-statement/ webcite]
• [4]ECRIN Certification of Data Centres. [Available at http://www.ecrin.org/index.php?id=345 webcite]
• [5]Donabedian A: The quality of care: How can it be assessed? JAMA 1988, 260:1743-1748. [Available at http://post.queensu.ca/~hh11/assets/applets/The_Quality_of_Care__How_Can_it_Be_Assessed_-_Donabedian.pdf webcite]