There is a newer version of this record available.

Other Open Access

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; Ohmann, Christian; Palmer, Gilles; Pêgo, José Miguel; Pham, Catherine; Ruckes, Christian; Wittenberg, Michael


DCAT Export

<?xml version='1.0' encoding='utf-8'?>
<rdf:RDF xmlns:rdf="http://www.w3.org/1999/02/22-rdf-syntax-ns#" xmlns:adms="http://www.w3.org/ns/adms#" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:dct="http://purl.org/dc/terms/" xmlns:dctype="http://purl.org/dc/dcmitype/" xmlns:dcat="http://www.w3.org/ns/dcat#" xmlns:duv="http://www.w3.org/ns/duv#" xmlns:foaf="http://xmlns.com/foaf/0.1/" xmlns:frapo="http://purl.org/cerif/frapo/" xmlns:geo="http://www.w3.org/2003/01/geo/wgs84_pos#" xmlns:gsp="http://www.opengis.net/ont/geosparql#" xmlns:locn="http://www.w3.org/ns/locn#" xmlns:org="http://www.w3.org/ns/org#" xmlns:owl="http://www.w3.org/2002/07/owl#" xmlns:prov="http://www.w3.org/ns/prov#" xmlns:rdfs="http://www.w3.org/2000/01/rdf-schema#" xmlns:schema="http://schema.org/" xmlns:skos="http://www.w3.org/2004/02/skos/core#" xmlns:vcard="http://www.w3.org/2006/vcard/ns#" xmlns:wdrs="http://www.w3.org/2007/05/powder-s#">
  <rdf:Description rdf:about="https://doi.org/10.5281/zenodo.32690">
    <rdf:type rdf:resource="http://www.w3.org/ns/dcat#Dataset"/>
    <dct:type rdf:resource="http://purl.org/dc/dcmitype/Text"/>
    <dct:identifier rdf:datatype="http://www.w3.org/2001/XMLSchema#anyURI">https://doi.org/10.5281/zenodo.32690</dct:identifier>
    <foaf:page rdf:resource="https://doi.org/10.5281/zenodo.32690"/>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>Canham, Steve</foaf:name>
        <foaf:givenName>Steve</foaf:givenName>
        <foaf:familyName>Canham</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>Independent consultant</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>Clivio, Luca</foaf:name>
        <foaf:givenName>Luca</foaf:givenName>
        <foaf:familyName>Clivio</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>Mario Negri Institute, Milano</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>Cornu, Catherine</foaf:name>
        <foaf:givenName>Catherine</foaf:givenName>
        <foaf:familyName>Cornu</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>Centre d'Investigation Clinique, Hospices Civils de Lyon, Lyon</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>Crocombe, Will</foaf:name>
        <foaf:givenName>Will</foaf:givenName>
        <foaf:familyName>Crocombe</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>Leeds Institute of Clinical Trials Research</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>De Bremaeker, Nancy</foaf:name>
        <foaf:givenName>Nancy</foaf:givenName>
        <foaf:familyName>De Bremaeker</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>Clinical and Epidemiological Investigation Center, Luxembourg Institute of Health</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>Domingues, Carlos</foaf:name>
        <foaf:givenName>Carlos</foaf:givenName>
        <foaf:familyName>Domingues</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>Data Centre, Coimbra Coordinating Centre for Clinical Research, AIBILI, Coimbra</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>Faherty, Michael</foaf:name>
        <foaf:givenName>Michael</foaf:givenName>
        <foaf:familyName>Faherty</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>National University of Ireland, Galway</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>Gueyffier, François</foaf:name>
        <foaf:givenName>François</foaf:givenName>
        <foaf:familyName>Gueyffier</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>Clinical Pharmacology and Clinical Trials Department, University Hospitals, Faculté Laennec, Lyon</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>Lauritsen, Jens</foaf:name>
        <foaf:givenName>Jens</foaf:givenName>
        <foaf:familyName>Lauritsen</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>Dept. of Biostatistics, Odense University, Odense</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>Nicolis, Enrico Bjørn</foaf:name>
        <foaf:givenName>Enrico Bjørn</foaf:givenName>
        <foaf:familyName>Nicolis</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>Mario Negri Institute, Milano</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>Ohmann, Christian</foaf:name>
        <foaf:givenName>Christian</foaf:givenName>
        <foaf:familyName>Ohmann</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>European Clinical Research Infrastructures Network (ECRIN), Prinz-Georg-Str. 51, 40477 Düsseldorf</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>Palmer, Gilles</foaf:name>
        <foaf:givenName>Gilles</foaf:givenName>
        <foaf:familyName>Palmer</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>Institut de Santé Publique, d'Epidémiologie et de Développement, Bordeaux</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>Pêgo, José Miguel</foaf:name>
        <foaf:givenName>José Miguel</foaf:givenName>
        <foaf:familyName>Pêgo</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>Life and Health Sciences Research Institute (ICVS), School of Health Sciences, University of Minho, Braga; ICVS-3Bs PT Government Associate Laboratory, Braga, Guimarães</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>Pham, Catherine</foaf:name>
        <foaf:givenName>Catherine</foaf:givenName>
        <foaf:familyName>Pham</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>PCG Clinical Services AB, Uppsala</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>Ruckes, Christian</foaf:name>
        <foaf:givenName>Christian</foaf:givenName>
        <foaf:familyName>Ruckes</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>Inter-disciplinary Centre for Clinical Trials (IZKS) Mainz</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:creator>
      <rdf:Description>
        <rdf:type rdf:resource="http://xmlns.com/foaf/0.1/Agent"/>
        <foaf:name>Wittenberg, Michael</foaf:name>
        <foaf:givenName>Michael</foaf:givenName>
        <foaf:familyName>Wittenberg</foaf:familyName>
        <org:memberOf>
          <foaf:Organization>
            <foaf:name>Centre for Clinical Trials, Philipps-University Marburg</foaf:name>
          </foaf:Organization>
        </org:memberOf>
      </rdf:Description>
    </dct:creator>
    <dct:title>Requirements for Certification of ECRIN Data Centres, with Explanation and Elaboration of Standards, Version 3.0</dct:title>
    <dct:publisher>
      <foaf:Agent>
        <foaf:name>Zenodo</foaf:name>
      </foaf:Agent>
    </dct:publisher>
    <dct:issued rdf:datatype="http://www.w3.org/2001/XMLSchema#gYear">2015</dct:issued>
    <dcat:keyword>clinical trials</dcat:keyword>
    <dcat:keyword>ECRIN</dcat:keyword>
    <dcat:keyword>certification</dcat:keyword>
    <dcat:keyword>standards</dcat:keyword>
    <dcat:keyword>data management</dcat:keyword>
    <dcat:keyword>clinical research IT</dcat:keyword>
    <dct:issued rdf:datatype="http://www.w3.org/2001/XMLSchema#date">2015-10-26</dct:issued>
    <owl:sameAs rdf:resource="https://zenodo.org/record/32690"/>
    <adms:identifier>
      <adms:Identifier>
        <skos:notation rdf:datatype="http://www.w3.org/2001/XMLSchema#anyURI">https://zenodo.org/record/32690</skos:notation>
        <adms:schemeAgency>url</adms:schemeAgency>
      </adms:Identifier>
    </adms:identifier>
    <dct:isVersionOf rdf:resource="https://doi.org/10.5281/zenodo.618250"/>
    <dct:isPartOf rdf:resource="https://zenodo.org/communities/ecrin"/>
    <owl:versionInfo>3.0</owl:versionInfo>
    <dct:description>&lt;p&gt;This document represents version 3 of the &amp;lsquo;Requirements for certification of data centres&amp;rsquo;, 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&amp;rsquo;s data centre Certification Board, and invited experts from a variety of trials units in Europe, and it reflects experience gained auditing trials units in 2014.&lt;/p&gt; &lt;p&gt;Over and above their use for certification, the requirements are intended to describe good practice in data and IT management in clinical research, and in clinical trials in particular. They were developed by senior staff working in non-commercial clinical trials units in Europe, and are intended as a practical guide for staff working in IT and data management in that sector (though the same principles apply to all clinical research environments).&lt;/p&gt; &lt;p&gt;The 129 requirements, or standards, included in the current version are divided into 19 separate lists, some focused on IT, some mainly concerned with data management, and some that deal with both. Each standard has a code, a title, and a single statement summarizing the requirement. This document provides, in addition, explanatory and elaboration material &amp;ndash; usually a few paragraphs that attempt to clarify each statement&amp;rsquo;s meaning, and / or give examples of its application, and which also indicate the evidence that would normally be used to assess a unit&amp;rsquo;s compliance. The document also includes a brief introduction to the standards and their development, including a description of the ECRIN audit process, and a glossary of terms.&lt;/p&gt;</dct:description>
    <dct:accessRights rdf:resource="http://publications.europa.eu/resource/authority/access-right/PUBLIC"/>
    <dct:accessRights>
      <dct:RightsStatement rdf:about="info:eu-repo/semantics/openAccess">
        <rdfs:label>Open Access</rdfs:label>
      </dct:RightsStatement>
    </dct:accessRights>
    <dcat:distribution>
      <dcat:Distribution>
        <dct:license rdf:resource="https://creativecommons.org/licenses/by/4.0/legalcode"/>
        <dcat:accessURL rdf:resource="https://doi.org/10.5281/zenodo.32690"/>
      </dcat:Distribution>
    </dcat:distribution>
    <dcat:distribution>
      <dcat:Distribution>
        <dcat:accessURL>https://doi.org/10.5281/zenodo.32690</dcat:accessURL>
        <dcat:byteSize>1177286</dcat:byteSize>
        <dcat:downloadURL>https://zenodo.org/record/32690/files/RequirementsForCertificationOfDataCentres_V3_20151026.pdf</dcat:downloadURL>
        <dcat:mediaType>application/pdf</dcat:mediaType>
      </dcat:Distribution>
    </dcat:distribution>
  </rdf:Description>
</rdf:RDF>
1,694
1,040
views
downloads
All versions This version
Views 1,694495
Downloads 1,040173
Data volume 1.1 GB203.7 MB
Unique views 1,499481
Unique downloads 876159

Share

Cite as