Publications

A European approach to clinical investigator training

Author(s)
Boeynaems JM, Canivet C, Chan A, Clark MJ, Cornu C, Daemen E, Demotes J, De Nys K, Hirst B, Hundt F, Kassai B.
Publication date
Journal reference
Frontiers in Pharmacology, 4 :1-5, 2013

Revising the ECRIN standard requirements for information technology and data management in clinical trials

Author(s)
Ohmann C, Canham S, Cornu C, Dreß J, Gueyffier F, Kuchinke W, Nicolis EB, Wittenberg M.
Publication date
Journal reference
Trials. 2013 Apr 5;14:97. doi: 10.1186/1745-6215-14-97.

Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis.

Author(s)
Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Åneman A, Madsen KR, Møller MH, Elkjær JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Søe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjældgaard AL, Fabritius ML, Mondrup F, Pott FC, Møller TP, Winkel P, Wetterslev J; 6S Trial Group; Scandinavian Critical Care Trials Group.
Publication date
Journal reference
N Engl J Med. 2012 Jul 12;367(2):124-34. doi: 10.1056/NEJMoa1204242. Epub 2012 Jun 27.

Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

Author(s)
Gluud C, Kubiak C, Whitfield K, Byrne J, Huemer KH, Thirstrup S, Libersa C, Barraud B, Grählert X, Dreier G, Geismann S, Kuchinke W, Temesvari Z, Blasko G, Kardos G, O'Brien T, Cooney M, Gaynor S, Schieppati A, de Andres F, Sanz N, Kreis G, Asker-Hagelberg C, Johansson H, Bourne S, Asghar A, Husson JM, Demotes-Mainard J.
Publication date
Journal reference
Trials. 2012 Mar 27;13:27. doi: 10.1186/1745-6215-13-27.

Disclosure of investigators' recruitment performance in multicenter clinical trials: a further step for research transparency

Author(s)
Dal-Ré R1, Moher D, Gluud C, Treweek S, Demotes-Mainard J, Carné X.
Publication date
Journal reference
PLoS Med. 2011 Dec;8(12):e1001149. doi: 10.1371/journal.pmed.1001149. Epub 2011 Dec 27.

A European perspective--the European clinical research infrastructures network

Author(s)
Demotes-Mainard J, Kubiak C.
Publication date
Journal reference
Ann Oncol. 2011 Nov;22 Suppl 7:vii44-vii49. doi: 10.1093/annonc/mdr425.

Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres

Author(s)
Kuchinke W1, Ohmann C, Yang Q, Salas N, Lauritsen J, Gueyffier F, Leizorovicz A, Schade-Brittinger C, Wittenberg M, Voko Z, Gaynor S, Cooney M, Doran P, Maggioni A, Lorimer A, Torres F, McPherson G, Charwill J, Hellström M, Lejeune S.
Publication date
Journal reference
Trials. 2010 Jul 21;11:79. doi: 10.1186/1745-6215-11-79.

Harmonisation of ethics committees' practice in 10 European countries

Author(s)
Harmonisation of ethics committees' practice in 10 European countries
Hernandez R, Cooney M, Dualé C, Gálvez M, Gaynor S, Kardos G, Kubiak C, Mihaylov S, Pleiner J, Ruberto G, Sanz N, Skoog M, Souri P, Stiller CO, Strenge-Hesse A, Vas A, Winter D, Carné X.
Publication date
Journal reference
J Med Ethics. 2009 Nov;35(11):696-700. doi: 10.1136/jme.2009.030551.

Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

Author(s)
Kubiak C, de Andres-Trelles F, Kuchinke W, Huemer KH, Thirstrup S, Whitfield K, Libersa C, Barraud B, Grählert X, Dreier G, Grychtol R, Temesvari Z, Blasko G, Kardos G, O'Brien T, Cooney M, Gaynor S, Schieppati A, Sanz N, Hernandez R, Asker-Hagelberg C, Johansson H, Bourne S, Byrne J, Asghar A, Husson JM, Gluud C, Demotes-Mainard J.
Publication date
Journal reference
Trials. 2009 Oct 16;10:95. doi: 10.1186/1745-6215-10-95.

European Clinical Research Infrastructures Network: promoting harmonisation and quality in European clinical research

Author(s)
Demotes-Mainard J, Ohmann C.
Publication date
Journal reference
Lancet. 2005 Jan 8-14;365(9454):107-8.