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临床研究的发展正处于一个新时代的门槛,其中电子病历正发挥着重要的支撑作用。虽然目前电子病历用于常规临床研究有一定的局限性,但新的改进系统和新兴研究基础设施正处在开发阶段,以确保电子病历可以在临床研究中发挥辅助作用。电子病历系统应当能够通过使用最近出版的、互操作性的国际标准和临床验证信息结构来交换信息,以确保记录的一致性和完整性,以及各种患者群体的数据共享,这样的系统将抵消对不同临床语言和文件方式以及公认的常规记录不完整性的障碍。本文对应用电子病历系统进行临床研究的若干问题做出探讨。
The development of clinical research is at the threshold of a new era, of which electronic medical records are playing an important supporting role. Although electronic medical records have some limitations for routine clinical research, new systems for improvement and emerging research infrastructures are in the developmental stages to ensure that electronic medical records can play a supporting role in clinical research. EHR systems should be able to exchange information by using the recently published, interoperable international standards and clinical validation information structures to ensure record consistency and completeness and data sharing across patient groups that will offset Obstacles to different clinical language and documentary approaches and to the perceived incompleteness of routine records. This article discusses the application of electronic medical record system for clinical research.