publication . Other literature type . Other ORP type . 2018

Requirements For Certification Of Ecrin Data Centres, With Explanation And Elaboration Of Standards, Version 4.0

Canham, Steve; Gasco, Alex Bernalte; Crocombe, Will; De Bremaeker, Nancy; Domingues, Carlos; Faherty, Michael; Morales, Maria Teresa Garcia; Houston, Laura; Lauritsen, Jens; Nicolis, Enrico Bjørn; ...
Open Access English
  • Published: 27 Apr 2018
  • Publisher: Zenodo
Abstract
This is version 4.0 of the ‘Requirements for certification of data centres’, published by ECRIN, the European Clinical Research Infrastructure Network. 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 2017 and 2018 by ECRIN auditors, members of ECRIN’s data centre Certification Board, and invited experts from a variety of trials units in Europe. Over and above their use for certification, the requirements are intended to ...
Subjects
free text keywords: clinical trials, ECRIN, certification, standards, data management, clinical research IT, Medicine, Biotechnology, Science Policy, Infectious Diseases, Biological Sciences not elsewhere classified
Communities
Science and Innovation Policy Studies
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Other ORP type . 2018
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Other literature type . 2018
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Other literature type . 2018
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