A document used to define and manage the trial usually sent by the Industry Sponsor or the lead site if it is a multi-center study. Not all studies will include a protocol, but studies that involve investigational drugs; investigational devices will always have this document. The protocol describes the scientific rationale, objective(s), design, methodology, statistical considerations and organization of the planned trial. The protocol contains a precise study plan to assure safety and health of the trail subjects and to provide an exact template for trial conduct by investigators. This allows data to be combined across all investigators/sites. The format and content of clinical trial protocols sponsored by pharmaceutical, biotechnology, or medical device companies in the United States, European Union, or Japan have been standardized to follow Good Clinical Practice guidance.