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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)
BACKGROUND: 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. METHODS: In order to summarise the current situation...
Autores principales: | Kubiak, Christine, de Andres-Trelles, Fernando, Kuchinke, Wolfgang, Huemer, Karl-Heinz, Thirstrup, Steffen, Whitfield, Kate, Libersa, Christian, Barraud, Béatrice, Grählert, Xina, Dreier, Gabriele, Grychtol, Ruth, Temesvari, Zsuzsa, Blasko, Gyorgy, Kardos, Gabriella, O'Brien, Timothy, Cooney, Margaret, Gaynor, Siobhan, Schieppati, Arrigo, Sanz, Nuria, Hernandez, Raquel, Asker-Hagelberg, Charlotte, Johansson, Hanna, Bourne, Sue, Byrne, Jane, Asghar, Adeeba, Husson, Jean-Marc, Gluud, Christian, Demotes-Mainard, Jacques |
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Formato: | Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2009
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2768680/ https://www.ncbi.nlm.nih.gov/pubmed/19835581 http://dx.doi.org/10.1186/1745-6215-10-95 |
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