摘要
目的:利用计算机网络技术,实现医疗机构药物临床试验信息化管理。方法:在医院信息系统基础上研发药物临床试验专用操作模块,实施信息化的操作模式并评价其效果。结果与结论:在医院信息系统中成功嵌入免费医嘱管理、试验药物管理和机构监管模块,研究者可以在系统中进行免费检查检验、开处方以及免费药物发放的操作,机构可以通过系统实现对临床试验的过程监控。使用该管理模式后,加快了试验的开展,住院受试者的血常规报告反馈时间由1d缩短至1h,核磁共振报告反馈时间由2d缩短至1d。该模式极大地方便了机构对各临床试验项目进行药物管理、过程监管、数据溯源和数据统计等工作,提高了临床试验的安全性和数据的准确性,使临床试验质量管理更科学。
OBJECTIVE： To implement information management for drug clinical trial by computer and network technology in medical institution. METHODS： The operation module used specially for drug clinical trial were researched and developed based on the hospital information system. Information operation model was implemented. RESULTS ＆ CONCLUSIONS： The investigator can prescribe free medical order and distribute free drugs, and the institution can monitor the procedure, due to the success of the hospital information system embedded the modules of free medical order management, trial drugs management and institution moni- toring. The mode speeds up the development of trials, the feedback time of blood routine reports has been reduced from 1 d to 1 h, and the feedback time of magnetic resonance imaging reports has been reduced from 2 d to 1 d. The mode is convenient for institu- tion to conduct drug management, procedure supervision, data tracing, data statistics, etc. It also improve the safety of clinical tri- als and the accuracy of data, and promote more scientific quality management of clinical trials.
出处
《中国药房》
CAS
北大核心
2015年第4期445-447,共3页
China Pharmacy
关键词
医疗机构
药物临床试验
信息化管理
操作
模式
Medical institution
Drug clinical trial
Information management
Operation
Mode
