GCP inspections in Germany and Europe following the implementation of the Directive 2001/20/EC

Claus Göbel, Dieter Baier, Birgit Ruhfus & Ferdinand Hundt
Background: The implementation of the Clinical Trials Directive 2001/20/EC and the Good Clinical Practice Directive 2005/28/EC fundamentally restructured and harmonized the conduct of clinical trials in Europe. GCP inspections – which affect study sites, laboratories, sponsors and contract research organizations (CRO) alike – make up an important part of these regulations. A common understanding of how these regulations apply in daily life is however not always ensured. Methods: A working group of the Clinical Research/Quality...