Regulations for Good Clinical Practice Article 70
The sponsor should ensure that written procedures include:1.The instructions that the investigator and the institution should follow for the handling and storage of investigational product(s).2.Procedures about handling, storage, dispensing, retrieval of unused product from subjects, and return of unused investigational product(s) to the sponsor.
中文原文 藥品優良臨床試驗作業準則第70條
試驗委託者所訂定之書面程序中，應包括下列事項：
一、試驗主持人與試驗機構應遵守試驗藥品處理及保存程序之文字。
二、藥品之處理、貯存、發藥、自受試者處取回餘藥、將餘藥歸還試驗委託者之程序。
一、試驗主持人與試驗機構應遵守試驗藥品處理及保存程序之文字。
二、藥品之處理、貯存、發藥、自受試者處取回餘藥、將餘藥歸還試驗委託者之程序。