為落實受試者保護之目的，當研究結束後，若仍有研究相關之安全議題時，應確實遵守試驗機構IRB規定及執行人體研究之安全性通報與監測。
如：例行報告與緊急事件報告依照人體試驗委員會要求之期限繳交。
敬請遵循以下規定:
1.安全性通報(Safety reporting)
a1人體研究期間，若試驗委託者或其代理人知悉試驗產品之非預期嚴重不良反應，應依法進行通報。
(During the human study, it shall report according to the regulations if Sponsor or its representative has known the unexpected serious adverse event of the investigational product.)
a2人體研究結束後，若知悉有研究相關的重要安全議題時，試驗委託者應盡快以書面通知研究單位。
( After the human study is ended, it shall inform the research unit in document format should be faster from the day of knowing if Sponsor has known the investigational product is importantly related to safety of the human subject.)
2.安全性監測(Safety monitoring)
試驗委託者或其代理人應負責人體研究之資料與安全監測，並提供安全監測報告給計畫主持人及人體試驗委員會；應至少每年提供例行報告，緊急事件報告應於30日內通報。
(Sponsor or its representative shall be responsible for data and safety monitoring for the human study, and providing the principal investigator and the Institutional Review Board of Study site with the data and safety monitoring reports. The routine reports shall be provided at least annually , and the emergency reports shall be raised within 30 days.)
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