Erschienen in:
01.02.2007 | News
Clinical research in Italy in adult patients unable to consent: after implementation of the European Union's Directive 2001/20/CE
verfasst von:
Christian J. Wiedermann, Mauro Almici, Salvatore Mangione, Antonello Giarratano, Oswald Mayr
Erschienen in:
Intensive Care Medicine
|
Ausgabe 2/2007
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Excerpt
The European Union's Directive 2001/20/CE (“the Clinical Trials Directive”) was intended to simplify and harmonize the regulation of clinical trials across the EU and had to be implemented in member states by May 2004 [
1]. It makes “good clinical practice” a legal requirement in the EU, and all clinical research is to be subjected to the same rigorous standards including protection of trial subjects. Some of these requirements, however, may be seen additional burden and a brake to clinical research in Europe [
2,
3,
4,
5,
6,
7]. …