The Impact of ICH GCP Guidelines on Clinical Research Quality and Ethics
The International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline is a set of standards and principles for the design, conduct, recording, and reporting of clinical trials involving human subjects. The guideline was developed by the ICH, a tripartite organization composed of regulatory authorities and industry representatives from Europe, Japan, and the United States, with the participation of other regions and organizations such as Australia, Canada, China, the World Health Organization, and others. Objectives ICH GCP The main objectives of the ICH GCP Guideline are to protect the rights, safety, and well-being of human subjects participating in clinical trials and to ensure the scientific validity and credibility of the data collected in human clinical studies. The guideline covers various aspects of clinical research, such as the roles and responsibilities of sponsors, investigators, ethics committees, monitors, and auditors; the requirements for protocol d