Regulations on Human Trials Article 12
The medical care institution shall report to the central competent authority when the Trial Subject experiences any of the following occurrences during the Human Trial period or anytime when any of the following occurrences are related to the Human Trial:1. Death.2. Life-threatening.3. Permanent mental and physical disability.4. where the fetus or newborn of the Trial Subject suffers congenital malformations.5. Complications requiring hospitalization or prolonged hospitalization.6. Other complications possibly causing permanent damages.The medical care institution shall make such report referred to in the preceding paragraph within seven (7) days after learning of the occurrence(s) and submit detailed investigation information to the central competent authority within fifteen (15) days.
中文原文 人體試驗管理辦法第12條
受試者於人體試驗施行期間發生下列情事，或任何時間發生與人體試驗有關之下列情事時，醫療機構應通報中央主管機關：
一、死亡。
二、危及生命。
三、永久性身心障礙。
四、受試者之胎兒或新生兒先天性畸形。
五、需住院或延長住院之併發症。
六、其他可能導致永久性傷害之併發症。
前項通報應於得知事實後七日內為之，並於十五日內檢具詳細調查資料送中央主管機關。
一、死亡。
二、危及生命。
三、永久性身心障礙。
四、受試者之胎兒或新生兒先天性畸形。
五、需住院或延長住院之併發症。
六、其他可能導致永久性傷害之併發症。
前項通報應於得知事實後七日內為之，並於十五日內檢具詳細調查資料送中央主管機關。