通过分析信息化系统在人员培训与授权、知情同意、临床试验过程数据采集、质量保证体系运行等方面的作用，结合新型冠状病毒疫情期间临床试验信息化技术应用的现状，总结经验，提出信息化对药物临床试验带来的益处和可能存在的问题。临床研究的信息化明显提升试验质量，但同时也可能带来一定的风险，包括数据安全、系统供应商的资质、法规层面的认可等。药物临床试验信息化是大势所趋，该过程中存在的问题必须通过系统持续改进而逐步解决，从而建立更全面的质量管理体系。

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

国家自然科学基金资助项目（81403414）；上海市卫健委临床研究专项（201940063）；上海市“科技创新行动计划”生物医药科技支撑专项（20S21902100）；上海申康医院发展中心“市级医院医企协同临床试验管理项目”（20CR4003B）；上海市卫计委“杏林新星”项目（ZYSNXD011-RC-XLXX-20130049）；“中西医结合-中成药临床评价平台”（A1-U21-205-0103）