论文部分内容阅读
目的 按照药物临床试验质量管理规范(good clinical practice,GCP)标准,建立传染病防治药物临床试验信息管理平台。方法 按照GCP的临床试验规则,采用J2EE技术、Struts和Hibernate的三层体系架构及数据库技术,构建传染病防治药物临床信息管理平台。结果 建立了包括电子数据采集系统、临床试验数据系统、GCP项目管理系统和中央随机化管理系统在内的传染病药物临床信息管理平台。结论 使用传染病防治药物临床信息管理平台,显著增强了临床试验质量控制,为建立符合国际规范的传染病防治药物评价体系,准确评价药物的疗效和安全性奠定了基础。
Objective To establish a clinical trial information management platform for infectious disease prevention and control according to the standard of good clinical practice (GCP). Methods According to the clinical trial rules of GCP, a three-tier architecture and database technology of J2EE technology, Struts and Hibernate were used to build a clinical information management platform for infectious disease prevention and treatment. Results The clinical information management platform for infectious diseases including electronic data collection system, clinical trial data system, GCP project management system and central randomized management system was established. Conclusion The use of clinical information management platform for infectious disease prevention and control significantly enhances the quality control of clinical trials and lays the foundation for establishing a drug evaluation system for infectious disease prevention and control in line with international norms and accurately evaluating the efficacy and safety of drugs.