chapter  24
12 Pages

European CT Directive: Implementation and Update

ByKent Hill, Richard A. Guarino

BACKGROUND 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 the European Union (EU) and the Far East, the differences in complying with local national requirements have presented an increasing administrative workload for sponsors and regulators.