Regulations for Good Clinical Practice Article 76
The sponsor should determine the appropriate scope and nature of monitoring. The determination of the scope and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, scale, and endpoints of the trial.On-site monitoring should be conducted before, during, and after the trial. However, the sponsor may increase some monitoring procedures such as investigators’ training or meetings.Statistically controlled sampling can be an acceptable method for monitor(s) to select the data to be verified.
中文原文 藥品優良臨床試驗作業準則第76條
試驗委託者應決定適當之監測範圍及性質。
監測範圍與性質之決定應考量試驗之目標、目的、設計、複雜性、盲性、規模及療效指標。
試驗開始前、試驗期間及試驗後，應進行實地監測。
但試驗委託者得增加試驗主持人訓練或會議等監測程序。
監測者選擇驗證數據時，得以統計抽樣方式為之。
監測範圍與性質之決定應考量試驗之目標、目的、設計、複雜性、盲性、規模及療效指標。
試驗開始前、試驗期間及試驗後，應進行實地監測。
但試驗委託者得增加試驗主持人訓練或會議等監測程序。
監測者選擇驗證數據時，得以統計抽樣方式為之。