Read publications that ECRIN has contributed to

Publications

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.
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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.
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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.
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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.
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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.
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Droit communautaire : vers une évolution de la Directive 2001/20/EC ?

Author(s)
Demotes-Mainard J.
Publication date
Journal reference
Gazette du Palais 142 :8-10 (2009).
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Future developments of medical informatics from the viewpoint of networked clinical research

Author(s)
Ohmann C, Kuchinke W
Publication date
Journal reference
Methods of information in medicine. 2009;48(01):45-54.
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Public-private partnership models in France and in Europe

Author(s)
Demotes-Mainard J, Canet E, Segard L
Publication date
Journal reference
Therapie. 2006 Jul 1;61(4):325-34.
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Extended cooperation in clinical studies through exchange of CDISC metadata between different study software solutions

Author(s)
Kuchinke W, Wiegelmann S, Verplancke P, Ohmann C
Publication date
Journal reference
Methods of information in medicine. 2006;45(04):441-6.
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Developing a European framework for research on children’s medicines

Author(s)
Seyberth HW, Demotes-Mainard J , Wrobel P

Publication date
Journal reference
Int. J. Pharm. Med, 19:37-41, 2005.
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