Regulations for Good Clinical Practice Article 67
In blinded trials, the coding system for the investigational product(s) should include a mechanism that permits rapid identification of the product(s) in case of a medical emergency, but does not permit undetectable breaks of the blinding.
中文原文 藥品優良臨床試驗作業準則第67條
盲性試驗之藥品代碼系統,應能於緊急情況時迅速辨別所使用之藥品,而不會破壞盲性設計之功能。