综合性医院临床试验免费诊疗信息系统的构建及实施评价

The construction and implementation evaluation of free diagnosis and treatment information system for clinical trial in general hospital

临床试验免费诊疗是临床试验质量管理的重点难题,南京医科大学鼓楼临床医学院基于医院信息系统(HIS)构建了临床试验免费诊疗信息系统。本研究通过调查问卷,对2016年12月参加临床试验的研究者、辅助科室研究者、机构管理人员等进行调研。调查显示,大部分研究者认为临床试验诊疗信息系统操作简单、便捷,大大优化了受试者检查、诊疗流程,提高了研究者的工作效率,保证了临床试验数据链的完整性和可溯性。通过实施临床试验免费诊疗信息系统,实现了临床试验免费诊疗的全流程动态监管和试验数据的实时抓取,提高了临床试验质量管理水平。

The free diagnosis and treatment of clinical trial is the key problem of the quality management of the clinical trial,the free diagnosis and treatment information system of clinical trial based on the hospital information system(HIS)was constructed by the Drum Tower clinical medical school of Nanjing Medical University.In December 2016,the investigators,the researchers from assistant department and the management personnel of the clinical trial participated in the investigation by the designed questionnaire.The investigation showed that most of the researchers believe that the clinical trial diagnosis and treatment information system is simple and convenient to operate,and it greatly optimized the subject’s examination,diagnosis and treatment process.It also improved the working efficiency of the researchers,and ensured the integrity and accessibility of the clinical trial data link.Through the implementation of the system,the real time grasping of the whole process dynamic supervision and test data of free diagnosis and treatment of clinical trial is realized,and the quality management level of the clinical trial is improved,and the clinical trial free diagnosis and treatment information system is worthy of further popularization and application in the future.