Regulations for Good Clinical Practice Article 117
When conducting a multicenter trial, all investigators should conduct the trial in compliance with the protocol agreed to by the sponsor and approved by the Competent Authority, and by the Ethics Committee.
中文原文 藥品優良臨床試驗作業準則第117條
進行多機構合作臨床試驗時，所有試驗主持人應遵守經試驗委託者所同意，並經人體試驗委員會及主管機關所核准之試驗計畫書。