Good clinical practice (GCP) is an international ethical standard guidance for designing, conducting, auditing, and reporting quality clinical trials. Note that clinical trials are defined as studies intended to discover new treatments or explore adverse reactions of novel investigation products in human subjects. Since clinical studies involve the participation of human beings, compliance with the GCP standards is crucial to ensure the safety, well-being, and confidentiality of all trial subjects.
While the GCP guidelines were finalized in 1996, the standards were enforced worldwide a decade later. Note that GCP was initially introduced by the International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), whose aim is to bring experts across Europe, the US, and Japan together (Vijayananthan & Nawawi, 2008). The history behind the formation of the guidelines is regrettable: disastrous events, such as World War II and the manufacturing of unsafe medications (e.g., maternal thalidomide), stressed the importance of voluntary consent of human subjects and drug safety testing. The Nuremberg Code, the Declaration of Helsinki, the Kefauver-Harris Amendments, the Belmont Report, and the International Guidelines for Biomedical Research Involving Human Subjects were the first milestones in the development of the GCP standards. Now the ICH-GCP is an essential factor in medical research.