Publications

ECRIN (European Clinical Research Infrastructures Network) Et La Structuration De La Recherche Clinique en Europe

Author(s)
Demotes-Mainard J
Publication date
Journal reference
Bulletin de l'Académie nationale de médecine. 2010 Dec;194(9):1683-94.

Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries.

Author(s)
Whitfield K, Huemer KH, Winter D, Thirstrup S, Libersa C, Barraud B, Kubiak C, Stankovski L, Grählert X, Dreier G, Geismann S
Publication date
Journal reference
Trials. 2010 Nov 12;11:104.

The Coordinating Centers for Clinical Trials (KKS) and the KKS Network: competence for clinical research

Author(s)
Ohmann C, Bruns I, Wolff S
Publication date
Journal reference
Onkologie. 2010;33:11-5.

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.

Clinical Trials Legislation-Preparing for the Revision of the European Directive Scheduled for 2011

Author(s)
Bilbault P, Belorgey C, Zannad F, Golinelli D, Pletan Y, Abiteboul M, Bertram D, Cornu C, Chassany O, Demotes-Mainard J, Demarez JP
Publication date
Journal reference
Therapie. 2010 Jul 1;65(4):301-8.

Has the European Clinical Trials Directive been a success?

Author(s)
Frewer LJ, Coles DG, Champion K, Demotes-Mainard J, Goetbuget N, Ihrig K, Klingmann I, Kubiak C, Lejeune SA, McDonald F, Apperley JF
Publication date
Journal reference
Editorial. BMJ: British Medical Journal. 2010;340:937-8.

Risk analysis and risk adapted on-site monitoring in noncommercial clinical trials

Author(s)
Brosteanu O, Houben P, Ihrig K, Ohmann C, Paulus U, Pfistner B, Schwarz G, Strenge-Hesse A, Zettelmeyer U
Publication date
Journal reference
Clinical trials. 2009 Dec;6(6):585-96.

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.

CDISC standard-based electronic archiving of clinical trials

Author(s)
Kuchinke W, Aerts J, Semler SC, Ohmann C
Publication date
Journal reference
Methods of information in medicine. 2009;48(05):408-13.