Matsumura Yasushi, Hattori Atsushi, Manabe Shiro, Takahashi Daiyo, Yamamoto Yuichiro, Murata Taizo, Nakagawa Akito, Mihara Naoki, Takeda Toshihiro
Medical Informatics, Osaka University Graduate School of Medicine, Osaka, Japan.
MKS ltd, Osaka, Japan.
Stud Health Technol Inform. 2017;245:516-520.
To improve the efficiency of clinical research, we developed a system to integrate electronic medical records (EMRs) and the electronic data capture system (EDC). EDC is divided into case report form (CRF) reporter and CDMS with CRF receiver with data communication using the operational data model (ODM). The CRF reporter is incorporated into the EMR to share data witth the EMR. In the data transcription type, doctors enter data using a progress note template, which are transmitted to the reporter template. It then generates the ODM. In the direct record type, reporter templates open from the progress note and generate narrative text to make record in the progress note. The configuration files for a study are delivered from the contents server to minimize the setup. This system has been used for 15 clinical studies including 3 clinical trials. This system can save labor and financial costs in clinical research.
为提高临床研究效率，我们开发了一个整合电子病历（EMR）和电子数据捕获系统（EDC）的系统。EDC分为病例报告表（CRF）报告器和带有CRF接收器的临床数据管理系统（CDMS），通过操作数据模型（ODM）进行数据通信。CRF报告器被整合到EMR中，以便与EMR共享数据。在数据转录类型中，医生使用病程记录模板输入数据，这些数据会被传输到报告器模板。然后生成ODM。在直接记录类型中，报告器模板从病程记录中打开，并生成叙述性文本以在病程记录中进行记录。研究的配置文件从内容服务器交付，以尽量减少设置。该系统已用于15项临床研究，包括3项临床试验。该系统可以节省临床研究中的人力和财务成本。
