Regulations for Good Clinical Practice Article 48
When the investigator, the institution or any trial staff fails to comply with the protocol or this Regulations, the sponsor should adopt immediate measures to ensure the compliance.While the investigator or the institution does not adopt the measures referred to in the preceding paragraph, the sponsor should take action in accordance with Article 116.
中文原文 藥品優良臨床試驗作業準則第48條
試驗主持人、試驗機構或試驗委託者之試驗相關人員不遵從試驗計畫書或本準則之規定時，試驗委託者應採取迅速之措施以確保其遵從。
試驗主持人、試驗機構不遵從前項措施者，試驗委託者應依第一百十六條之規定處理。
試驗主持人、試驗機構不遵從前項措施者，試驗委託者應依第一百十六條之規定處理。