Regulations for Good Clinical Practice Article 108
For reported deaths, the sponsor, the Ethics Committee, and the Competent Authority may request the investigator to provide autopsy reports, terminal medical reports and any additional information.
中文原文 藥品優良臨床試驗作業準則第108條
發生死亡病例時，試驗委託者、人體試驗委員會與主管機關得要求試驗主持人提出驗屍報告、最終醫療紀錄及其他任何額外資訊。