해당 임상시험의 배경이나 근거를 제공하기 위해 임상시험의 목적‧연구방법론‧통계학적 측면‧관련 조식 등이 기술된 문서

A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced.