Regulations for Good Clinical Practice Article 59
If the sponsor discontinues the clinical development of an investigational product, the sponsor should notify all the trial investigators, institutions and the Competent Authority.Under the preceding circumstance, the sponsor shall maintain all sponsor-specific essential documents for at least 2 years after formal discontinuation. 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59條
試驗委託者終止試驗藥品之臨床研發工作時，應通知所有試驗主持人、試驗機構及主管機關。
前項情形，試驗委託者應保存第五十八條之必要文件至試驗正式停止後至少二年。
但其他法規規定之保存期間長於二年者，從其規定。
前項情形，試驗委託者應保存第五十八條之必要文件至試驗正式停止後至少二年。
但其他法規規定之保存期間長於二年者，從其規定。