Clinical trial authorization guideline - EFDA/GDL/005, 3rd edition

Abstract

Clinical research is necessary to establish the relative safety and effectiveness of specific health and pharmaceutical products and healthcare practices. Much of what is known today about the risk and benefits of specific products and treatments has come from randomized controlled clinical trials that are designed to answer important scientific and health care questions. However, early 1960, there were widespread concern about the safety and control of investigational drugs and the clinical research process developed among members of medical profession, scientific community, regulatory authorities, and the public. This concern and subsequent international meeting serves a base for the development of Good Clinical Practice (GCP) at an international level, later developed by International Council for Harmonization (ICH). According to article 4 sub article 11 of the Food and