Regulations for Good Clinical Practice Article 80
A sponsor's audit should be independent of and separate from routine monitoring or quality control functions. The purpose of auditing is to evaluate trial conduct and compliance with the protocol, SOPs, this Regulations, and the applicable regulatory requirements.
中文原文 藥品優良臨床試驗作業準則第80條
試驗委託者之稽核為獨立之制度，且不在監測及品質管制功能內，其目的為評估試驗之執行且確保其遵守試驗計畫書、標準作業程序、本準則及相關法規之要求。