Regulations for Good Clinical Practice Article 65
The sponsor should determine, for the investigational product(s), acceptable storage temperatures, storage conditions, storage times, reconstitution fluids and procedures, and devices for product infusion, and should inform monitors, investigators, pharmacists, storage managers and any other involved parties.
中文原文 藥品優良臨床試驗作業準則第65條
試驗委託者應決定試驗藥品之儲存溫度、儲存條件、儲存時間、溶劑及注射器材，並通知監測者、試驗主持人、藥師、倉儲及其他相關人員。