Regulations for Good Clinical Practice Article 81
Selection and qualification of auditors should comply with:1.The sponsor should appoint individuals, who are independent of the clinical trials and data capture systems, to conduct audits.2.The sponsor should ensure that the auditors are qualified by training and experience to conduct audits properly. An auditor’s qualifications should be documented.
中文原文 藥品優良臨床試驗作業準則第81條
稽核者之任用應符合下列規定：
一、試驗委託者應任用臨床試驗及數據收集系統以外之人員進行稽核。
二、稽核者所受訓練應足以適任執行稽核，並以書面證明稽核者之資歷。
一、試驗委託者應任用臨床試驗及數據收集系統以外之人員進行稽核。
二、稽核者所受訓練應足以適任執行稽核，並以書面證明稽核者之資歷。