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

Christine Kubiak; Fernando de Andres-Trelles; Wolfgang Kuchinke; Karl-Heinz Huemer; Steffen Thirstrup; Kate Whitfield; Christian Libersa; Béatrice Barraud; Xina Grählert; Gabriele Dreier; Ruth Grychtol; Zsuzsa Temesvari; Gyorgy Blasko; Gabriella Kardos; Timothy O'Brien; Margaret Cooney; Siobhan Gaynor; Arrigo Schieppati; Nuria Sanz; Raquel Hernandez; Charlotte Asker-Hagelberg; Hanna Johansson; Sue Bourne; Jane Byrne; Adeeba Asghar; Jean-Marc Husson; Christian Gluud; Jacques Demotes-Mainard

doi:10.1186/1745-6215-10-95

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

Christine Kubiak, Fernando de Andres-Trelles, Wolfgang Kuchinke, Karl-Heinz Huemer, Steffen Thirstrup, Kate Whitfield, Christian Libersa, Béatrice Barraud, Xina Grählert, Gabriele Dreier, Ruth Grychtol, Zsuzsa Temesvari, Gyorgy Blasko, Gabriella Kardos, Timothy O'Brien, Margaret Cooney, Siobhan Gaynor, Arrigo Schieppati, Nuria Sanz, Raquel HernandezCharlotte Asker-Hagelberg, Hanna Johansson, Sue Bourne, Jane Byrne, Adeeba Asghar, Jean-Marc Husson, Christian Gluud, Jacques Demotes-Mainard

Copenhagen Trial Unit Rigshospitalet

13 Citationer (Scopus)

Abstract

Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states.

Originalsprog	Engelsk
Tidsskrift	Trials
Vol/bind	10
Sider (fra-til)	95
ISSN	1745-6215
DOI	https://doi.org/10.1186/1745-6215-10-95
Status	Udgivet - 2009

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10.1186/1745-6215-10-95

Citationsformater

Kubiak, C., de Andres-Trelles, F., Kuchinke, W., Huemer, K.-H., 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., ... Demotes-Mainard, J. (2009). Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN). Trials, 10, 95. https://doi.org/10.1186/1745-6215-10-95

Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN). / Kubiak, Christine; de Andres-Trelles, Fernando; Kuchinke, Wolfgang et al.
I: Trials, Bind 10, 2009, s. 95.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Kubiak, C, de Andres-Trelles, F, Kuchinke, W, Huemer, K-H, 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, J-M, Gluud, C & Demotes-Mainard, J 2009, 'Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)', Trials, bind 10, s. 95. https://doi.org/10.1186/1745-6215-10-95

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T2 - a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

AU - Kubiak, Christine

AU - de Andres-Trelles, Fernando

AU - Kuchinke, Wolfgang

AU - Huemer, Karl-Heinz

AU - Thirstrup, Steffen

AU - Whitfield, Kate

AU - Libersa, Christian

AU - Barraud, Béatrice

AU - Grählert, Xina

AU - Dreier, Gabriele

AU - Grychtol, Ruth

AU - Temesvari, Zsuzsa

AU - Blasko, Gyorgy

AU - Kardos, Gabriella

AU - O'Brien, Timothy

AU - Cooney, Margaret

AU - Gaynor, Siobhan

AU - Schieppati, Arrigo

AU - Sanz, Nuria

AU - Hernandez, Raquel

AU - Asker-Hagelberg, Charlotte

AU - Johansson, Hanna

AU - Bourne, Sue

AU - Byrne, Jane

AU - Asghar, Adeeba

AU - Husson, Jean-Marc

AU - Gluud, Christian

AU - Demotes-Mainard, Jacques

PY - 2009

Y1 - 2009

N2 - Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states.

AB - Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states.

KW - Biomedical Research

KW - Clinical Trials as Topic

KW - Data Collection

KW - Europe

KW - Humans

U2 - 10.1186/1745-6215-10-95

DO - 10.1186/1745-6215-10-95

M3 - Journal article

C2 - 19835581

SN - 1745-6215

VL - 10

SP - 95

JO - Trials

JF - Trials

ER -

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

Abstract

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