Regulations for Good Clinical Practice Article 107
When adverse events or laboratory abnormalities are identified as critical to safety evaluations, the investigator should report to the sponsor within the time periods specified by the sponsor in the protocol.
中文原文 藥品優良臨床試驗作業準則第107條
發生與試驗藥品安全性評估相關之不良反應或異常實驗室檢查值時，試驗主持人應於試驗計畫書規定之時間內向試驗委託者提出書面報告。