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藥品臨床試驗(yàn)機(jī)構(gòu)資格認(rèn)證管理平臺(tái)建設(shè)探討

發(fā)布時(shí)間:2018-05-11 07:40

  本文選題:臨床試驗(yàn) + 可視化 ; 參考:《中國(guó)新藥雜志》2017年05期


【摘要】:目的:探索現(xiàn)有數(shù)據(jù)信息的有效整合方式和模式,進(jìn)而實(shí)現(xiàn)臨床試驗(yàn)數(shù)據(jù)的實(shí)時(shí)更新、統(tǒng)計(jì)及多角度可視化呈現(xiàn)。方法:通過(guò)文獻(xiàn)調(diào)研法、專家咨詢法等了解國(guó)內(nèi)外藥物臨床試驗(yàn)基本現(xiàn)狀以及相關(guān)數(shù)據(jù)的規(guī)范指標(biāo)。再對(duì)藥物臨床試驗(yàn)相關(guān)數(shù)據(jù)的清洗、分析、整合,建立數(shù)據(jù)清洗標(biāo)準(zhǔn)規(guī)范表,利用可視化地圖等方法展現(xiàn)現(xiàn)有藥物臨床試驗(yàn)基本情況。結(jié)果:目前已經(jīng)完成了對(duì)藥物臨床試驗(yàn)開(kāi)展基本情況、機(jī)構(gòu)資格認(rèn)定及復(fù)核的情況的梳理,形成了相應(yīng)的數(shù)據(jù)庫(kù)。同時(shí)在藥品臨床試驗(yàn)機(jī)構(gòu)認(rèn)證管理平臺(tái)上,可視化地圖方式能清晰展示相關(guān)信息。結(jié)論:該平臺(tái)能為決策部門提供準(zhǔn)確實(shí)時(shí)的數(shù)據(jù)情報(bào)及相關(guān)建議,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.
【作者單位】: 中國(guó)醫(yī)學(xué)科學(xué)院醫(yī)學(xué)信息研究所;軍事醫(yī)學(xué)科學(xué)院毒物藥物研究所;百時(shí)美施貴寶(中國(guó))投資有限公司;
【基金】:中央級(jí)公益性科研院所基本科研業(yè)務(wù)費(fèi)項(xiàng)目(2016ZX330024)
【分類號(hào)】:R954

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本文編號(hào):1873032


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