Regulations on Human Trials Article 13
The central competent authority may order the medical care institution that conducts the Human Trial to provide relevant information, such as a summary of Human Trial proposal, case numbers, sex ratio, age statistics, review results of Trial Subject consent forms, and possible risks; or conduct necessary audit which the medical care institution shall not impede, avoid, or refuse.The audit referred to in the preceding paragraph may be done by relevant organizations as entrusted by the central competent authority.
中文原文 人體試驗管理辦法第13條
中央主管機關得令施行人體試驗之醫療機構提供人體試驗計畫摘要、收案數、性別比、年齡統計、受試者同意書審查結果及可能風險等有關資料，或對醫療機構進行必要之查核，醫療機構不得妨礙、規避或拒絕。
前項查核，中央主管機關得委託相關團體為之。
前項查核，中央主管機關得委託相關團體為之。