ICH GCP
Good clinical practice (GCP) is an international quality standard for conducting clinical trials, in some countries, provided by the ICH, an international body which defines a set of standards, which can then be used to translate into clinical trials for human subjects. . The GCP follows the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH). Clinical clintude of ethical aspects of GCP applies strict guidelines. High standards are required in full documentation of clinical protocol, record keeping, training and facilities, including computers and software. Quality assurance and inspections guarantee compliance with these standards. The GCP aims to ensure that the studies are scientifically authentic and that the investigational product of the clinical properties is properly documented.
GCP guidelines include protecting the human rights of subjects and volunteers in a clinical trial. It also develops new compounds of safety and efficacy. The GCP guidelines include standards for how clinical trials should be conducted, defined by the roles and responsibilities of institutional review committees, clinical researchers, clinical trial sponsors and monitors. In the pharmaceutical industry, monitors are often called clinical research associates.
Last Updated on: Nov 22, 2024