Regulations for Good Clinical Practice Article 49
The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, this Regulations, and the applicable regulatory requirement(s).
中文原文 藥品優良臨床試驗作業準則第49條
試驗委託者應以書面標準作業程序規定並持續執行品質保證及品質管制系統，以確保試驗進行及數據之產生、紀錄與報告皆遵守試驗計畫書與本準則之要求。