Regulations for Good Clinical Practice Article 16
Prior to the beginning of the trial, the investigator shall obtain the approval from the Ethics Committee for the informed consent form and any other written information to be provided to subjects.The approval referred to in the preceding paragraph should be made in writing.
中文原文 藥品優良臨床試驗作業準則第16條
臨床試驗開始前，試驗主持人應取得人體試驗委員會對受試者同意書和提供受試者之任何其他書面資料之核准。
前項核准，應以書面為之。
前項核准，應以書面為之。