Regulations for Good Clinical Practice Article 78
The monitor(s) should follow the sponsor’s established written SOPs as well as those procedures that are specified by the sponsor for monitoring a specific trial.
中文原文 藥品優良臨床試驗作業準則第78條
監測者應遵守試驗委託者建立之書面標準作業程序，及試驗委託者為監測特定試驗而指定之程序。