Regulations for Good Clinical Practice Article 105
The investigator shall promptly provide written reports to the sponsor, the Ethics Committee and the Competent Authority on any situation significantly affecting the conduct of the trial, and/or increasing the risk to subjects.
中文原文 藥品優良臨床試驗作業準則第105條
發生重大影響臨床試驗執行或增加受試者風險之情形，試驗主持人應立即向試驗委託者、人體試驗委員會及主管機關提出書面報告。