Regulations for Good Clinical Practice Article 73
The sponsor shall take into account the risk over subjects’ protection and data integrity when establishing a monitoring plan, in order to ensure that the trial is conducted under appropriate monitoring.The sponsor may choose on-site monitoring, system remote monitoring, or both.Where the system remote monitoring referred to in the preceding paragraph is adopted, the same shall be implemented only upon a reasonable assessment to verify the adequacy thereof.The contents of the plan referred to in Paragraph 1 cover the monitoring strategies, the monitoring responsibilities, the monitoring methods and reasons for adoption of the plan, as well as key data and processes to be monitored.
中文原文 藥品優良臨床試驗作業準則第73條
試驗委託者應考量受試者保護及數據完整性的風險，訂定監測計畫，確保試驗於適當之監測下執行。
試驗委託者得選擇實地監測、系統遠端監測或實地合併系統遠端監測。
前項監測，僅採行系統遠端監測者，應先經合理性評估，確認其適當性後，方得為之。
第一項計畫之內容包括監測策略、監測人員之職責、監測方法與採行理由，及應監測之關鍵數據與過程。
試驗委託者得選擇實地監測、系統遠端監測或實地合併系統遠端監測。
前項監測，僅採行系統遠端監測者，應先經合理性評估，確認其適當性後，方得為之。
第一項計畫之內容包括監測策略、監測人員之職責、監測方法與採行理由，及應監測之關鍵數據與過程。