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目的 建立具有自主知识产权的传染病防治药物临床试验管理系统,为传染病防治药物的研发提供技术保障。方法 本系统严格按照药品临床试验管理规范要求的业务流程和标准,基于J2EE开发平台,使用了BioKnow-UAP框架体系,运用Struts、Hibernate等架构技术和Oracle数据库存储数据。结果 本系统建立了标准化的临床试验评价手段和体系,并构建了严密的质量控制体系,保证临床评价数据管理的可靠性,健全了高效的人员培训体系,使药物临床研究更加符合人体生物医学研究伦理学要求,能够承担传染病防治药物的Ⅰ-Ⅳ期临床试验研究。结论 本系统成功构建了符合药品临床试验管理规范及适于传染病防治药物研究的临床试验评价体系,具有较高的实用价值。
Objective To establish a clinical trial management system for infectious disease prevention and treatment with independent intellectual property rights and to provide technical support for the development of infectious disease prevention and treatment drugs. Methods The system strictly follows the business processes and standards required by the clinical trial management standards of pharmaceuticals. Based on the J2EE development platform, the system uses the BioKnow-UAP framework and uses the architecture technologies such as Struts and Hibernate to store data. Results The system established a standardized clinical trial evaluation tools and systems and built a strict quality control system to ensure the reliability of clinical evaluation data management and improve the efficient staff training system to make the drug clinical research more in line with human biomedical research Ethical requirements, to undertake infectious disease prevention and treatment of drug Ⅰ-Ⅳ clinical trials. Conclusion The system has successfully constructed a clinical trial evaluation system that conforms to the management standards of clinical trials of drugs and is suitable for the study of infectious disease prevention and treatment drugs, and has a high practical value.