隨著我國加入國際人用藥品注冊技術(shù)協(xié)調(diào)會（ICH），提高機(jī)構(gòu)管理質(zhì)量顯得尤為重要，手工記錄方式已不能滿足當(dāng)前大數(shù)據(jù)時代信息化管理需求。鑒于此，軟件公司已基于信息化技術(shù)相繼開發(fā)出醫(yī)院機(jī)構(gòu)管理系統(tǒng)并將其運(yùn)用于機(jī)構(gòu)管理。介紹當(dāng)前醫(yī)院機(jī)構(gòu)管理系統(tǒng)在臨床試驗(yàn)中的運(yùn)用，討論機(jī)構(gòu)管理系統(tǒng)普及后可能出現(xiàn)的問題，并提出應(yīng)對措施，以供其他臨床試驗(yàn)機(jī)構(gòu)參考。

With China joining the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), it is particularly important to improve the quality of institution management, and the manual recording method has been unable to meet the current informatization management needs in the big data era. In view of this, software companies have successively developed hospital institution management systems based on information technology and applied them to institution management. This paper introduces application of hospital institution management system in clinical trials, and discusses the problems that may arise after the popularization of institution management system, and propose countermeasures for the reference of other clinical trial institutions.

R954

湖南省自然科學(xué)基金科藥聯(lián)合基金資助項(xiàng)目（2020JJ9049）