The European Union Directive on Good Clinical Practice in Clinical Trials: Implications for Future Research

Since finalization in 1996, the International Committee on Harmonisation Tripartite Guideline for Good Clinical Practice (ICH GCP) underpinned by the ethical principles of the Declaration of Helsinki have been the cornerstones upon which most clinical research has been conducted outside the United States (1, 2). However, in such a widely disparate and expanding territory as Europe (EU), the national differences in complying with local national requirements have presented a highly resource-hungry administrative workload for sponsors.