药品临床试验机构资格认证管理平台建设探讨

发布时间：2018-05-11 07:40

本文选题：临床试验 + 可视化　；参考：《中国新药杂志》2017年05期

【摘要】：目的:探索现有数据信息的有效整合方式和模式,进而实现临床试验数据的实时更新、统计及多角度可视化呈现。方法:通过文献调研法、专家咨询法等了解国内外药物临床试验基本现状以及相关数据的规范指标。再对药物临床试验相关数据的清洗、分析、整合,建立数据清洗标准规范表,利用可视化地图等方法展现现有药物临床试验基本情况。结果:目前已经完成了对药物临床试验开展基本情况、机构资格认定及复核的情况的梳理,形成了相应的数据库。同时在药品临床试验机构认证管理平台上,可视化地图方式能清晰展示相关信息。结论:该平台能为决策部门提供准确实时的数据情报及相关建议,并提高其管理效率。
[Abstract]:Objective: to explore the effective integration methods and models of the existing data information, and to realize the real-time updating, statistical and multi-angle visualization of clinical trial data. Methods: through literature research and expert consultation, to understand the basic status of drug clinical trials at home and abroad as well as the standard indicators of relevant data. Then the cleaning, analysis, integration, establishment of data cleaning standard and specification table, visual map and other methods to show the basic situation of current drug clinical trials. Results: the basic conditions, institutional qualification and review of drug clinical trials have been completed, and the corresponding database has been formed. At the same time, the visual map can clearly display the relevant information on the certification management platform of drug clinical trial organization. Conclusion: the platform can provide accurate and real-time data information and relevant advice for decision-making department and improve its management efficiency.
【作者单位】：中国医学科学院医学信息研究所;军事医学科学院毒物药物研究所;百时美施贵宝(中国)投资有限公司;
【基金】：中央级公益性科研院所基本科研业务费项目(2016ZX330024)
【分类号】：R954

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