通過分析信息化系統(tǒng)在人員培訓(xùn)與授權(quán)、知情同意、臨床試驗過程數(shù)據(jù)采集、質(zhì)量保證體系運行等方面的作用，結(jié)合新型冠狀病毒疫情期間臨床試驗信息化技術(shù)應(yīng)用的現(xiàn)狀，總結(jié)經(jīng)驗，提出信息化對藥物臨床試驗帶來的益處和可能存在的問題。臨床研究的信息化明顯提升試驗質(zhì)量，但同時也可能帶來一定的風(fēng)險，包括數(shù)據(jù)安全、系統(tǒng)供應(yīng)商的資質(zhì)、法規(guī)層面的認(rèn)可等。藥物臨床試驗信息化是大勢所趨，該過程中存在的問題必須通過系統(tǒng)持續(xù)改進而逐步解決，從而建立更全面的質(zhì)量管理體系。

Experiences were summarized by analyzing the effects of informationization on personnel training and authorization, informed consent, clinical trial data collection and quality assurance system operation, combined with the current status of clinical trial information technology application during the epidemic. The benefits and potential problems of informationization for clinical trials were proposed. Informatization of clinical research obviously improved trial quality, but at the same time it might also bring certain risks including data security, qualification of system suppliers and regulatory approval. Information-based drug clinical trials will inevitably become a general trend, during which the problems must be gradually solved through continuous systematic improvement so as to establish a more comprehensive quality management system.

R696.4

國家自然科學(xué)基金資助項目（81403414）；上海市衛(wèi)健委臨床研究專項（201940063）；上海市“科技創(chuàng)新行動計劃”生物醫(yī)藥科技支撐專項（20S21902100）；上海申康醫(yī)院發(fā)展中心“市級醫(yī)院醫(yī)企協(xié)同臨床試驗管理項目”（20CR4003B）；上海市衛(wèi)計委“杏林新星”項目（ZYSNXD011-RC-XLXX-20130049）；“中西醫(yī)結(jié)合-中成藥臨床評價平臺”（A1-U21-205-0103）