<unk>  <unk>  is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects.<unk>  follows the International Council for Harmonisation of Technical Requirements for 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. Quality assurance and inspections ensure that these standards are achieved.<unk>  aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented.<unk>  guidelines include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds.<unk>  guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called clinical research associates. A series of unsuccessful and ineffective clinical trials in the past were the main reason for the creation of ICH and<unk>  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.
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