摘要
笔者首先提出了药物临床试验机构管理的难度和临床试验机构管理系统建设的必要性。其次介绍了药物临床试验机构管理系统的研究与实践,通过信息化手段来解决机构在管理上的诸多问题。最后着重阐明了临床试验门户网站建设、用户权限管理、项目申报审批流程、数据多条件实时统计以及系统操作日志等技术方案,并提出该系统应用对医院和临床试验发展的优势。
The author first puts forward the difficulty of the management of drug clinical trial institutions and the necessity of the construction of clinical trial institution management system. Secondly, it introduces the research and practice of the drug clinical trial institution management system, and solves many problems in the management of the institution through informational means. Finally,it focuses on the clinical trial portal construction, user rights management, project declaration and approval process, data multicondition real-time statistics and system operation log and other technical solutions, and puts forward the advantages of the system application for hospital and clinical trial development.
引文
[1]吴伟,杨克旭,超颖超,等.对临床试验管理系统提高药物临床试验机构管理水平的研究[J].中国临床药理学杂志,2015,31(13):1318-1320.
[2]曹彩,熊宁宁.药物临床试验机构的管理[J].中国临床药理学杂志,2011,27(12):992-996.