Raising standards in clinical research – The impact of the ECRIN data centre certification programme, 2011–2016

The nature and the purpose of the ECRIN Data Centre Certification Programme are summarised, and a very brief description is given of the underlying standards (129 in total, divided into 19 separate lists). The certification activity performed so far is described. In a pilot phase 2 centres were cert...

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Autores principales: Ohmann, C., Canham, S., Demotes, J., Chêne, G., Lauritsen, J., Martins, H., Mendes, R.V., Nicolis, E.B., Svobodnik, A., Torres, F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2017
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5936703/
https://www.ncbi.nlm.nih.gov/pubmed/29740631
http://dx.doi.org/10.1016/j.conctc.2017.02.005
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author Ohmann, C.
Canham, S.
Demotes, J.
Chêne, G.
Lauritsen, J.
Martins, H.
Mendes, R.V.
Nicolis, E.B.
Svobodnik, A.
Torres, F.
author_facet Ohmann, C.
Canham, S.
Demotes, J.
Chêne, G.
Lauritsen, J.
Martins, H.
Mendes, R.V.
Nicolis, E.B.
Svobodnik, A.
Torres, F.
author_sort Ohmann, C.
collection PubMed
description The nature and the purpose of the ECRIN Data Centre Certification Programme are summarised, and a very brief description is given of the underlying standards (129 in total, divided into 19 separate lists). The certification activity performed so far is described. In a pilot phase 2 centres were certified in 2012. Calls in 2014 and 2015 resulted in a further 8 certified centres, with 2 certifications still in progress, and the 2016 call has generated several additional applications. The impact and benefits of the programme are listed, divided into a) the effects of the introduction of the standards, b) the effects of the certification programme in general, and c) the effects of the certification programme on individual units. The discussion emphasises the generally positive impact of the programme so far but stresses the need to better clarify the perspective and role of the programme.
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spelling pubmed-59367032018-05-08 Raising standards in clinical research – The impact of the ECRIN data centre certification programme, 2011–2016 Ohmann, C. Canham, S. Demotes, J. Chêne, G. Lauritsen, J. Martins, H. Mendes, R.V. Nicolis, E.B. Svobodnik, A. Torres, F. Contemp Clin Trials Commun Article The nature and the purpose of the ECRIN Data Centre Certification Programme are summarised, and a very brief description is given of the underlying standards (129 in total, divided into 19 separate lists). The certification activity performed so far is described. In a pilot phase 2 centres were certified in 2012. Calls in 2014 and 2015 resulted in a further 8 certified centres, with 2 certifications still in progress, and the 2016 call has generated several additional applications. The impact and benefits of the programme are listed, divided into a) the effects of the introduction of the standards, b) the effects of the certification programme in general, and c) the effects of the certification programme on individual units. The discussion emphasises the generally positive impact of the programme so far but stresses the need to better clarify the perspective and role of the programme. Elsevier 2017-02-14 /pmc/articles/PMC5936703/ /pubmed/29740631 http://dx.doi.org/10.1016/j.conctc.2017.02.005 Text en © 2017 The Authors http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Ohmann, C.
Canham, S.
Demotes, J.
Chêne, G.
Lauritsen, J.
Martins, H.
Mendes, R.V.
Nicolis, E.B.
Svobodnik, A.
Torres, F.
Raising standards in clinical research – The impact of the ECRIN data centre certification programme, 2011–2016
title Raising standards in clinical research – The impact of the ECRIN data centre certification programme, 2011–2016
title_full Raising standards in clinical research – The impact of the ECRIN data centre certification programme, 2011–2016
title_fullStr Raising standards in clinical research – The impact of the ECRIN data centre certification programme, 2011–2016
title_full_unstemmed Raising standards in clinical research – The impact of the ECRIN data centre certification programme, 2011–2016
title_short Raising standards in clinical research – The impact of the ECRIN data centre certification programme, 2011–2016
title_sort raising standards in clinical research – the impact of the ecrin data centre certification programme, 2011–2016
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5936703/
https://www.ncbi.nlm.nih.gov/pubmed/29740631
http://dx.doi.org/10.1016/j.conctc.2017.02.005
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