Department of Medicine II, Hospital of the LMU Munich, 81377, Munich, Germany.
German Center for Infection Research, Partner Site Munich, 81377, Munich, Germany.
Sci Rep. 2024 Aug 17;14(1):19056. doi: 10.1038/s41598-024-69550-w.
Our prototype system designed for clinical data acquisition and recording of studies is a novel electronic data capture (EDC) software for simple and lightweight data capture in clinical research. Existing software tools are either costly or suffer from very limited features. To overcome these shortcomings, we designed an EDC software together with a mobile client. We aimed at making it easy to set-up, modifiable, scalable and thereby facilitating research. We wrote the software in R using a modular approach and implemented existing data standards along with a meta data driven interface and database structure. The prototype is an adaptable open-source software, which can be installed locally or in the cloud without advanced IT-knowledge. A mobile web interface and progressive web app for mobile use and desktop computers is added. We show the software's capability, by demonstrating four clinical studies with over 1600 participants and 679 variables per participant. We delineate a simple deployment approach for a server-installation and indicate further use-cases. The software is available under the MIT open-source license. Conclusively the software is versatile, easily deployable, highly modifiable, and extremely scalable for clinical studies. As an open-source R-software it is accessible, open to community-driven development and improvement in the future.
我们设计的用于临床数据采集和研究记录的原型系统是一种新颖的电子数据采集(EDC)软件,用于在临床研究中进行简单轻便的数据采集。现有的软件工具要么价格昂贵,要么功能非常有限。为了克服这些缺点,我们一起设计了一个 EDC 软件和一个移动客户端。我们的目标是使它易于设置、可修改、可扩展,从而促进研究。我们使用模块化方法用 R 编写了该软件,并实现了现有的数据标准以及元数据驱动的接口和数据库结构。原型是一个适应性强的开源软件,可以在没有先进 IT 知识的情况下在本地或云端安装。添加了用于移动设备和桌面计算机的移动网络接口和渐进式网络应用程序。我们通过展示四个超过 1600 名参与者和每个参与者 679 个变量的临床研究来说明软件的功能。我们描述了一种简单的服务器安装部署方法,并指出了进一步的用例。该软件根据 MIT 开源许可证提供。总之,该软件功能多样,易于部署,高度可修改,并且对临床研究具有极高的可扩展性。作为一个开源 R 软件,它易于访问,开放供社区驱动的开发和未来的改进。