Regulations for Good Clinical Practice Article 101
The investigator and the institution should pay sufficient attention to properly maintain all the important trial documents, and take measures to prevent accidental or premature destruction of these documents.The documents referred to in the preceding paragraph shall be retained until at least 2 years after approval of the marketing application of the investigational product(s) in Taiwan. However, these documents shall be retained for a longer period if required by other applicable regulatory requirements.
中文原文 藥品優良臨床試驗作業準則第101條
試驗主持人及試驗機構應盡善良管理人之注意，妥善保管所有臨床試驗相關重要文件，並防止遭受意外之破壞或提早銷毀。
前項文件，應保存至試驗藥品於我國獲准上市後至少二年。
但其他法規規定之保存期間長於二年者，從其規定。
前項文件，應保存至試驗藥品於我國獲准上市後至少二年。
但其他法規規定之保存期間長於二年者，從其規定。