我院新型药物临床试验电子信息化管理系统

A new electronic administration system of clinical trials in our hospital

探讨临床试验GCP电子信息化管理平台建设及其在药物临床试验中的应用。我院与南京某软件公司共同研发《药物临床试验项目管理系统》,并与医院原有的HIS,LIS,RIS等系统对接,对药物临床试验进行电子信息化管理。目前已经被采用的有项目管理、办公室管理、电子化验申请单管理、伦理审查、药物管理、系统维护等模块。同时注重专业化人员梯队建设、硬件设施及软件系统的配套应用,逐步实现药物临床试验电子信息化管理,提高了药物临床试验机构的管理效率。

To investigate and analyze the application of an electronic administration system for clinical tri- als, we designed the administration system cooperated with Najing Haitai Company, and successfully docked it with HIS, LIS and RIS systems. It is composed of parts, including project management, office management, manage- ment of electronic test application form, ethical review, drug management and system maintenance in the system. The researchers are regularly trained to consummate the professional personnel echelon construction. The system is updated in its software and hardware. The clinical trial projects using the electronic administration system are grad- ually realized, and the efficiency of the clinical trial is improved in the hospital.