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)

Hagen Russ, Susanne Busta, Axel Riedel, Gereon Zöllner & Bertfried Jost
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 12th Amendment of the German Medicines Act in August 2004. The experience of applicants (sponsors, legal representatives of sponsors in the EU and persons or organizations authorized by the sponsors to make the application, respectively) in terms of...