Evaluation of clinical trials by Ethics Committees in Germany - Experience of applicants with the review of requests for opinion of the Ethics Committees - results of a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA)

The review of requests for a positive opinion of the ethics committees (application procedure) as a requirement to start a clinical trial in Germany has been completely redesigned with the transposition of EU Directive 2001/20/EC in the 12(th) Amendment of the German Medicines Act in August 2004. Th...

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Bibliographische Detailangaben
Hauptverfasser: Russ, Hagen, Busta, Susanne, Riedel, Axel, Zöllner, Gereon, Jost, Bertfried
Format: Artigo
Sprache:Inglês
Veröffentlicht: German Medical Science GMS Publishing House 2009
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Article
Online Zugang:https://ncbi.nlm.nih.gov/pmc/articles/PMC2716553/
https://ncbi.nlm.nih.gov/pubmed/19675747
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3205/000066
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