Regulations for Good Clinical Practice Article 118
When conducting a multicenter trial, for those investigators who are collecting additional data according to the protocol, the sponsor should provide supplemental CRFs that are designed to capture the additional data.
中文原文 藥品優良臨床試驗作業準則第118條
進行多機構合作臨床試驗時，對於依試驗計畫書收集額外數據之試驗主持人，試驗委託者應提供能獲得額外數據之補充個案報告表。