Regulations for Good Clinical Practice Article 61
The sponsor should inform the investigator(s) and the institution(s) in writing of the need for record retention. When the trial related records are no longer needed, the sponsor should notify the investigator(s) and the institution(s) in writing.
中文原文 藥品優良臨床試驗作業準則第61條
試驗委託者應書面通知試驗主持人及試驗機構紀錄保存之必要性。
試驗相關紀錄無須繼續保存者，試驗委託者應書面通知試驗主持人及試驗機構。
試驗相關紀錄無須繼續保存者，試驗委託者應書面通知試驗主持人及試驗機構。