基于药物临床试验项目管理系统的临床试验全程管理

发布时间：2019-01-06 19:02

【摘要】：我国药物临床试验机构经过多年的发展,临床试验的试验条件质量有了一定的改善,但与发达国家相比,还存在着很多不足,应用信息化管理有助于提高药物临床试验质量管理。文章对医院II~IV期药物临床试验项目管理系统的总体功能进行介绍,该系统从临床试验项目管理出发,结合药物临床试验运行特点及流程,实现临床试验项目及药物全程管理,并与医院信息管理系统、实验室信息管理系统、医学影像信息系统接口,构建起机构办、药物管理部门、检验检查科室与研究者之间的公共信息平台,实现了数据共享。
[Abstract]:After years of development, the quality of the clinical trial conditions has improved, but compared with the developed countries, there are still many shortcomings. The application of information management is helpful to improve the quality management of drug clinical trials. This paper introduces the overall function of the II~IV phase drug clinical trial project management system in hospital. The system starts from the clinical trial project management, combines the running characteristics and process of the drug clinical trial, and realizes the clinical trial project and the whole drug management. And the common information platform between hospital information management system, laboratory information management system and medical image information system is constructed, and the public information platform between the department of medical administration, the department of drug administration, the department of inspection and the researcher is constructed, and the data sharing is realized.
【作者单位】：辽宁中医药大学附属第二医院;辽宁省中医药研究院;北京金灵兰信息技术有限责任公司;
【基金】：国家“十二五”重大新药创制项目(2012ZX09303-017) 国家临床重点专科建设项目经费资助国家中医药管理局临床中药学重点学科辽宁中医药大学杏林学者青蓝工程
【分类号】：R95

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