基于HIS的临床试验信息管理平台的设计与应用

Design and application of a clinical trial information management platform based on HIS

目的:优化临床试验开展方式,规范临床试验业务流程,从功能实现及数据管理等方面助力临床研究业务的开展。方法:全面调研临床试验业务需求,搭建覆盖临床试验Ⅰ、Ⅱ、Ⅲ、Ⅳ期项目的全流程、一体化信息管理平台。整体设计和规划平台与医院信息系统(HIS)的对接方案,采用一致的接口开发及部署方式,实现应用统一部署、数据统一管理。结果:临床试验信息管理平台的应用,既简化了业务流程,又提升了临床试验管理质量和效率。应用及数据资源的合理利用,也提高了业务的可扩展性。结论:采用整体规划、统一部署的方式搭建基于HIS的临床试验信息管理平台,能够在满足临床试验业务需求的前提下,降低系统研发成本,整合临床试验数据资源,使临床试验业务的开展更加安全、规范,在保证临床试验质量的同时提高了试验效率。

Objective To optimize the way of conducting clinical trials,standardize the business process of clinical trials,and help the development of clinical research business in terms of function implementation and data management.Methods On the basis of comprehensive research on clinical trial business needs,a whole process and integrated information management platform was built,covering clinical trial phase I,II,III and IV projects.Through the overall design and planning of the interface solution for platform and hospital information system(HIS),and the use of consistent interface development and deployment,a unified deployment of applications and a unified data management were achieved.Results By establishing and applying the clinical trial information management platform,it not only simplified the business process but also improved the quality and efficiency of clinical trial management.The rational utilization of application and data resources also improved the scalability of business.Conclusion The adoption of overall planning and unified deployment to build a clinical trial information management platform based on HIS can reduce system development costs and integrate clinical trial data resources while meeting the needs of clinical trial business,so that the clinical trial business can be conducted in a safer and more standardized manner and the efficiency of the trial can be improved while ensuring the quality of the clinical trial.