首页|药物临床试验稽查信息化管理平台的构建与应用

药物临床试验稽查信息化管理平台的构建与应用

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采用自主研发的报告管理系统(RMS)对稽查工作进行全流程管理,探索信息化管理在临床试验稽查中的应用。RMS以稽查工作流程为设计背景,以稽查报告内容为主体,稽查要点作为框架,设置问题录入端口。RMS多角色同步操作的功能提高了稽查效率;通过预设"条目"+"限定语"词典对问题进行分类分级,提高了报告的可读性和查阅便捷性;使用计算机检索和运算功能,实现了稽查问题的多维度分析,进一步完善了问题上报机制,实现临床试验质量持续改进。在符合稽查工作需求的同时,RMS也对数据的安全、隐私保护、修改轨迹等做出了设定。
Construction and Application of an Information Management Platform for Clinical Audit
A report management system(RMS)was independently designed and developed,which real-ized the management of whole process in clinical trial audit,aiming to explore the application of informa-tion management in clinical trial audit.RMS was designed with the audit workflow as the background,with the audit report as the main part,the audit check-points as the framework,and a port for problem input.The function of multi-role synchronous operation improved audit efficiency.The problems were classified and graded by a dictionary of categories and items,the reports were improved for readability and conve-nience of accessing.Computer retrieval and arithmetic supported multi-dimensional analysis,further im-proved reporting mechanism and achieved continuous improvement of clinical trial quality.In addition,the RMS also safeguarded data security,privacy protection and data modification trajectories.

Clinical trialAudit reportsReport Management SystemInformation management

王鸯、张旭松、张琳宁、章江伟、刘亚麟

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正大天晴药业集团股份有限公司,南京 211100

临床试验 稽查报告 报告管理系统 信息化管理

江苏省博士后科研资助计划(2005)

2024

药学与临床研究
江苏省药学会

药学与临床研究

CSTPCD
影响因子:0.95
ISSN:1673-7806
年,卷(期):2024.32(2)
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