Regulations for Good Clinical Practice Article 74
The purposes of trial monitoring are to verify that:1.The rights and well-being of human subjects are protected.2.The reported trial data are accurate, complete, and verifiable from source documents.3.The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with this Regulations, and with the applicable regulatory requirement(s).
中文原文 藥品優良臨床試驗作業準則第74條
監測之目的如下：
一、確保受試者之權利及福祉受到保護。
二、確保所報告之試驗數據準確、完整，且可自原始資料中查證。
三、確保試驗之執行符合已核准試驗計畫書及其修正書、本準則及相關法規之規定。
一、確保受試者之權利及福祉受到保護。
二、確保所報告之試驗數據準確、完整，且可自原始資料中查證。
三、確保試驗之執行符合已核准試驗計畫書及其修正書、本準則及相關法規之規定。