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
