Regulations for Good Clinical Practice Article 23
Prior to participation in the trial, the subject or the subject's legal representative and the legally acceptable representative shall receive a copy of the signed and dated informed consent form and any other written information provided to the subjects. The clinical trials intended for treating emergency cases when prior consent is not possible are exceptional.During a subject’s participation in the trial, the subject or the subject's legal representative and the legally acceptable representative. shall receive a copy of the signed and dated consent form updates and a copy of any amendments to the written information provided to subjects.
中文原文 藥品優良臨床試驗作業準則第23條
受試者、法定代理人或有同意權之人於參加臨床試驗執行前，應收到已簽名及載明日期之受試者同意書之副本及其他應提供受試者之書面資料。
但用以治療或處置緊急病況之臨床試驗，預期無法預先取得受試者或有同意權之人同意者，不在此限。
受試者參加臨床試驗期間，若同意書或其他應提供受試者之書面文件有修正，受試者、法定代理人或有同意權之人，應收到已簽名及載明日期之受試者同意書及其他修正文件之更新副本。
但用以治療或處置緊急病況之臨床試驗，預期無法預先取得受試者或有同意權之人同意者，不在此限。
受試者參加臨床試驗期間，若同意書或其他應提供受試者之書面文件有修正，受試者、法定代理人或有同意權之人，應收到已簽名及載明日期之受試者同意書及其他修正文件之更新副本。