GCP follows the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.
High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software.
GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented.
A series of unsuccessful and ineffective clinical trials in the past were the main reason for the creation of ICH and GCP guidelines in the US and Europe.
These discussions ultimately led to the development of certain regulations and guidelines, which evolved into the code of practice for international consistency of quality research.