Regulations for Good Clinical Practice Article 116
If the investigator or the institution seriously or repeatedly violates the protocol, the sponsor should stop the investigator or the institution from conducting the trial and promptly notify the Competent Authority.
中文原文 藥品優良臨床試驗作業準則第116條
試驗主持人或試驗機構重大或持續違反試驗計畫書，試驗委託者應終止其繼續參與臨床試驗，並立即通知主管機關。