publication . Other literature type . 2015

Requirements for Certification of ECRIN Data Centres, with Explanation and Elaboration of Standards, Version 3.0

Canham, Steve; Clivio, Luca; Cornu, Catherine; Crocombe, Will; De Bremaeker, Nancy; Domingues, Carlos; Faherty, Michael; Gueyffier, François; Lauritsen, Jens; Nicolis, Enrico Bjørn; ...
Open Access
  • Published: 26 Oct 2015
Abstract
This document represents version 3 of the ‘Requirements for certification of data centres’, published by ECRIN, the European Clinical Research Infrastructure Network (the first version was produced in 2011, and the second in 2012). The requirements are the criteria used by ECRIN to identify, and then certify, clinical trials units that can provide high quality, compliant and safe data management, as well as effective management of the underlying systems and IT infrastructure. This latest version results from a review in 2015 by ECRIN auditors, members of ECRIN’s data centre Certification Board, and invited experts from a variety of trials units in Europe, and it...
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free text keywords: clinical trials, ECRIN, certification, standards, data management, clinical research IT, clinical trials, ECRIN, certification, standards, data management, clinical research IT
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Other literature type . 2015
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Other literature type . 2015
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