For the European Union, a number of legal and ethical issues concerning clinical research on human subjects have been harmonised in Directive 2001/20. In the Directive a set of minimum requirements is given, which recently has been transposed into legislation of the member states. However, some room is given to the member states to implement certain rules at their own discretion.
Further to our monograph on Clinical Trial Liability Insurance, in this monograph we give an overview of the most important variations in the local laws of the EU member states and of countries that are not (yet) EU member states, but in which we have CMS offices.
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