Conducting a European multi-center trial: first experiences with the new EU Clinical Trials Directive from an academic perspective
- PMID: 18551324
- PMCID: PMC2518768
- DOI: 10.1007/s00586-008-0699-5
Conducting a European multi-center trial: first experiences with the new EU Clinical Trials Directive from an academic perspective
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References
-
- Anonymous (2001) Is the university–industrial complex out of control? Nature 409(6817):119 - PubMed
-
- Anonymous (2003) Who’s afraid of the European clinical trials Directive? Lancet 361(9376):2167 - PubMed
-
- Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official J Eur Communities 2001, L121:34–44 - PubMed
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