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

j 2017

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

OHMANN, C., S. CANHAM, J. DEMOTES, G. CHENE, J. LAURITSEN et. al.

Basic information

Original name

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

Authors

OHMANN, C., S. CANHAM, J. DEMOTES, G. CHENE, J. LAURITSEN, H. MARTINS, R. V. MENDES, E. B. NICOLIS, Adam SVOBODNÍK (203 Czech Republic, guarantor, belonging to the institution) and F. TORRES

Edition

CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS, SAN DIEGO, ELSEVIER INC, 2017

Other information

Language

English

Type of outcome

Článek v odborném periodiku (nerecenzovaný)

Field of Study

30230 Other clinical medicine subjects

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

RIV identification code

RIV/00216224:14110/17:00123157

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/j.conctc.2017.02.005

UT WoS

000399161700021

Keywords (in Czech)

clinical research; standards; ECRIN Data Centre

Keywords in English

clinical research; standards; ECRIN Data Centre

Abstract

V originále

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. (C) 2017 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license

Links

90090, large research infrastructures

Name: CZECRIN II

Citovat

OHMANN, C., S. CANHAM, J. DEMOTES, G. CHENE, J. LAURITSEN, H. MARTINS, R. V. MENDES, E. B. NICOLIS, Adam SVOBODNÍK and F. TORRES. Raising standards in clinical research - The impact of the ECRIN data centre certification programme, 2011-2016. CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS. SAN DIEGO: ELSEVIER INC, 2017, vol. 2017, No 5, p. 153-159. Available from: https://dx.doi.org/10.1016/j.conctc.2017.02.005.

@article{1807996,
   author = {Ohmann, C. and Canham, S. and Demotes, J. and Chene, G. and Lauritsen, J. and Martins, H. and Mendes, R. V. and Nicolis, E. B. and Svobodník, Adam and Torres, F.},
   article_location = {SAN DIEGO},
   article_number = {5},
   doi = {http://dx.doi.org/10.1016/j.conctc.2017.02.005},
   keywords = {clinical research; standards; ECRIN Data Centre},
   language = {eng},
   journal = {CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS},
   title = {Raising standards in clinical research - The impact of the ECRIN data centre certification programme, 2011-2016},
   url = {https://www.sciencedirect.com/science/article/pii/S2451865416300825?via%3Dihub},
   volume = {2017},
   year = {2017}
}

TY  - JFULL
ID  - 1807996
AU  - Ohmann, C. - Canham, S. - Demotes, J. - Chene, G. - Lauritsen, J. - Martins, H. - Mendes, R. V. - Nicolis, E. B. - Svobodník, Adam - Torres, F.
PY  - 2017
TI  - Raising standards in clinical research - The impact of the ECRIN data centre certification programme, 2011-2016
JF  - CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS
VL  - 2017
IS  - 5
SP  - 153-159
EP  - 153-159
PB  - ELSEVIER INC
KW  - clinical research
KW  - standards
KW  - ECRIN Data Centre
UR  - https://www.sciencedirect.com/science/article/pii/S2451865416300825?via%3Dihub
N2  - 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. (C) 2017 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license
ER  -

OHMANN, C., S. CANHAM, J. DEMOTES, G. CHENE, J. LAURITSEN, H. MARTINS, R. V. MENDES, E. B. NICOLIS, Adam SVOBODNÍK and F. TORRES. Raising standards in clinical research - The impact of the ECRIN data centre certification programme, 2011-2016. \textit{CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS}. SAN DIEGO: ELSEVIER INC, 2017, vol.~2017, No~5, p.~153-159. Available from: https://dx.doi.org/10.1016/j.conctc.2017.02.005.

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