為了保護參與臨床試驗的受試者，人體試驗委員會必須持續監測試驗安全，當接獲嚴重不良事件（serious adverse event, SAE）通報時，SAE審查藥師須評估其與試驗藥品之相關性及嚴重程度，以決定是否修改受試者同意書、計畫書或主持人手冊內容，然而為因應龐大的SAE案件通報必須建置一套資訊系統，以達到有效率的審核SAE案件。
本院人體試驗委員會「嚴重不良事件資訊系統」主要涵蓋以下四大功能：
(1) 線上通報功能：通報者可即時線上通報SAE。
(2) 監控管理：藉由電腦之監控，追蹤本院受試者之SAE達到緩解。
(3) 通報時效追蹤：提醒通報者達成藥品優良臨床試驗準則（good clinical practice, GCP）之通報時效規範。
(4) SAE審查及危險性監控：SAE審查藥師建置完整SAE資料庫，可有效率審查評估；當同一試驗案相同非預期SAE達五件以上時系統會自動警示。
利用線上通報SAE的功能可節省傳送文件的人力；此外，配合資料庫中的資料分析，有助於評估國內外與試驗藥品相關的安全訊息；2007年四月起建立SAE現況追蹤功能以來，共有68件SAE出現追蹤警示，且均追蹤至SAE不再持續發生為止；另一方面，2006年某一癌症用藥因為通報SAE數量眾多，藥師於整理過後發現其心臟毒性明顯，卻未載明於受試者同意書中，經會議討論後請廠商修改受試者同意書。
In order to protect the participating subjects in clinical trials, institutional review board (IRB) must continually monitor the safety of subjects. When a serious adverse event (SAE) occurred, the pharmacists in IRB assess the reported information to evaluate the relationship between the compound under investigation and the incident of the SAE and its severity. They have to decide whether an amendment to the inform consent form and protocol is necessary. Due to the growth of the number of research activities and increasing SAE reports, a computerized SAE evaluating system is developed to handle SAE cases efficiently.
This system is developed to function in the following four areas: (1) Online reporting: This function allows investigators to report SAEs online. (2) SAE monitoring and management: The function gives an alarm for each ongoing SAE case. (3) Time validity monitoring: It is a monitoring tool to ensure that investigators have complied with good clinical practice (GCP) and other applicable regulatory requirements. (4) SAE review and risk monitoring: Pharmacists can establish a SAE database for case review and data analysis. This function gives an automatic alarm when there are more than 5 SAE reports of same unexpected SAE term occurred in a single study.
Communication delay was saved for each SAE report. This system helps to evaluate the relevancy of a FDA MedWatch drug safety warning for local study sites. This system has helped the pharmacist to monitor 68 ongoing SAE reports in the past 21 months. In one study, an amendment to the informed consent form is added after a through follow up of the cardiotoxicity of the compound under investigation.
