基于医院信息环境的药物临床试验系统实施与应用

Clinical trial management system based on hospital information system

目的探讨临床试验信息管理系统在医院环境下运行与应用中遇到的问题。方法针对临床试验过程中HIS、LIS与PACS系统、门诊、医嘱、化验室检验、医技科室检查工作流程与临床试验的实际情况,进行系统构建,并介绍系统运行状况。结果通过临床试验系统的构建及与医院各个系统的对接,实现了药物临床试验过程中项目管理和全流程信息的控制,使临床试验的各个过程更加顺畅,做到了及时入组,实时信息更新,使研究者能够在实验室检验、电诊与放射线检查得到结果第一时间对受试者进行医学判断,提高了试验的效率,并使得机构办公室能够对试验的全部流程信息进行清晰的掌控。结论临床试验信息管理系统使试验项目管理更加准确、规范,并能够对试验的各个重要节点进行质量控制,能系统的提升药物临床试验机构的管理能力与办公效率。

Objective To discuss application problems of CTMS in our hospital. Methods Structure the system which needed to combine with the hospital＇s HIS,LIS,PACS and other certain departments,and illustrate operating situation of CTMS. Results Through the Interface technology combining of CTMS and other subsystem of our hospital,we achieved reality applications of CTMS and its whole process information control in clinic trials which smooth the process of clinic trial affaires. And this also achieved timely information inquiries of certain medical technology departments that investigators and administrators can read in the first time for medical judgment. The CTMS raised clinic trials operational efficiency. It makes clinic trials more accurate and standardized and key information controlled. Conclusion Clinical trial management system to make project management more accurate,specifications,and can carry on the quality control on every important node of the test,improve drug clinical trial management system ability and work efficiency.