ENGAGE Trial follows the Good Clinical Practice Guidance of the International Council for the Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), which constitutes an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Researchers’ compliance provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible/reliable. An additional objective of this guidance is to provide a unified standard of practice for Clinical Trials in the European Union (EU) and the United States, and to facilitate mutual acceptance of data by the regulatory authorities in these jurisdictions. The guidance was developed taking into account the individual practice guidelines of the European Union, the United States, Japan, Australia, Canada, the Nordic countries, and the World Health Organization (WHO).
You can read the Good Clinical Practice Guidance here.
Associate Professor of Obstetrics and Gynecology
National and Kapodistrian University of Athens