| 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过程化管理，并与医院信息管理系统（HIS）、实验室信息管理系统（LIS）、医学影像信息系统（PACS）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。 |
| 关键词: 药物临床试验项目管理系统 临床试验管理 受试者管理 药物管理 检验检查管理 |
| DOI： |
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| 基金项目: |
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| Clinical Trials Whole Course Management Based on the Drug Clinical Trial Project Management System |
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| Abstract: |
| The drug clinical trial institution in China has developed for years, test conditions of the quality of clinical trials have improved, but compared with developed countries, there are still many problems. The application of information management is helpful to improve the quality management of drug clinical trial. The paper introduces the overall function of phase the II～IV clinical trials of drug project management system. The system starts from the perspective of clinical trial project management, combines drug clinical trial operation characteristics and process, achieves clinical trial project and medicine whole process management, and interfaces Hospital Information Management System (HIS), Laboratory Information Management System (LIS), Medical Imaging Information System (PACS), establishes the public information platform between the drug administration department of inspection and the researchers, and realizes the data sharing. |
| Key words: drug clinical trial project management system,clinical trial management, subjects management, drug management,inspection management |
