Regulations for Good Clinical Practice Article 33
The investigator and the institution shall permit monitoring and auditing by the sponsor, and inspection by the Competent Authority or the delegated agencies.
中文原文 藥品優良臨床試驗作業準則第33條
試驗主持人及試驗機構應接受試驗委託者之監測與稽核，並接受主管機關或其指定機構之查核。