Regulations for Good Clinical Practice Article 39
If the protocol and Investigator's Brochure are updated during the trial, the investigator and the institution shall supply a copy of the updated ones to the Ethics Committee.
中文原文 藥品優良臨床試驗作業準則第39條
試驗計畫書及主持人手冊若在臨床試驗期間更新，試驗主持人及試驗機構應主動提供人體試驗委員會更新版本。