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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...
Autores principales: | , , , , |
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Formato: | Texto |
Lenguaje: | English |
Publicado: |
German Medical Science GMS Publishing House
2009
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2716553/ https://www.ncbi.nlm.nih.gov/pubmed/19675747 http://dx.doi.org/10.3205/000066 |