The European Directive upon the Imp...

The European Directive upon the Implementation of Good Clinical Practice (Directive 2001/20/EC) published in the Official Journal of the European Union in succession 4 April 2001, has become the focal point for the legal, regulatory, and ethical frameworks for clinical trials through every part of Europe. For the first time in Europe there is a central intimation point for the work of regulators, ethics committees, and sponsors (public and private) as regards their responsibilities and duties. Across the 25 European Union member states the couple old and (as of 1 May 2004) strange everyone involved in clinical