Good Clinical Practice

Good clinical practice (GCP) is an international quality standard that is provided by ICH, an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.
GCP enforces tight guidelines on ethical aspects of a clinical study.
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. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented.