Regulations for Good Clinical Practice Article 41
Before entering an agreement with an investigator and an institution to conduct a trial, the sponsor should provide the investigator(s) and the institution(s) with the protocol and an up-to-date Investigator's Brochure, and should provide sufficient time for the investigator to review the protocol and the information provided.
中文原文 藥品優良臨床試驗作業準則第41條
試驗委託者與試驗主持人及試驗機構達成協議執行試驗前，試驗委託者應提供試驗計畫書與最新版主持人手冊予試驗主持人及試驗機構，且應給予試驗主持人充分之時間檢閱試驗計畫書及相關資訊。