Regulations for Good Clinical Practice Article 43
A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO.The ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.The delegation referred to in the preceding paragraph should be made in writing.Within the scope of the transferred duties and obligations referred to paragraph 1, CRO shall apply mutatis mutandis to the relevant provisions of the sponsor in this Regulations.
中文原文 藥品優良臨床試驗作業準則第43條
試驗委託者得移轉部分或全部與試驗相關的權利與義務於受託研究機構。
但關於維護試驗數據的品質與完整性之最終責任，仍應由試驗委託者負責。
前項委託，應以書面為之。
於第一項移轉之權利義務範圍內，受託研究機構準用本準則有關試驗委託者之規定。
但關於維護試驗數據的品質與完整性之最終責任，仍應由試驗委託者負責。
前項委託，應以書面為之。
於第一項移轉之權利義務範圍內，受託研究機構準用本準則有關試驗委託者之規定。