【摘要】：目的研發(fā)中央隨機(jī)分配管理系統(tǒng)(web-based central randomization management system,WCRMS)。方法采用軟件研發(fā)中的生命周期法,將整個(gè)系統(tǒng)開(kāi)發(fā)過(guò)程劃分為系統(tǒng)規(guī)劃、系統(tǒng)分析、系統(tǒng)設(shè)計(jì)、系統(tǒng)實(shí)施以及系統(tǒng)維護(hù)5個(gè)階段進(jìn)行系統(tǒng)研制�；趪�(guó)際臨床數(shù)據(jù)交換標(biāo)準(zhǔn)協(xié)會(huì)(Clinical Data Interchange Standards Consortium,CDISC)標(biāo)準(zhǔn)進(jìn)行數(shù)據(jù)庫(kù)設(shè)計(jì),采用模型-視圖-控制器(Model View Controller,MVC)模式架構(gòu),web服務(wù)器采用穩(wěn)定的tomcat,數(shù)據(jù)庫(kù)連接池技術(shù)采用Proxool。結(jié)果我們成功的研制了中央隨機(jī)分配管理系統(tǒng),并且經(jīng)過(guò)多次測(cè)試,證明該系統(tǒng)具有穩(wěn)定性、可靠性和實(shí)時(shí)性。目前該系統(tǒng)正穩(wěn)定運(yùn)行中,它可以支持多個(gè)研究設(shè)計(jì)(多中心/單中心、盲法/非盲)、樣本量大小不一的臨床研究同時(shí)進(jìn)行,支持設(shè)盲研究緊急揭盲、動(dòng)態(tài)藥物管理。結(jié)論基于CDISC標(biāo)準(zhǔn)的數(shù)據(jù)庫(kù)設(shè)計(jì),保證了數(shù)據(jù)標(biāo)準(zhǔn)化與規(guī)范化,使系統(tǒng)能更好地與電子數(shù)據(jù)采集EDC系統(tǒng)進(jìn)行對(duì)接。利用本系統(tǒng),可使得隨機(jī)分配隱藏更加可靠,也可使項(xiàng)目管理員通過(guò)實(shí)時(shí)監(jiān)測(cè)項(xiàng)目各分中心進(jìn)度,采取對(duì)應(yīng)措施,縮短臨床研究周期、保證試驗(yàn)質(zhì)量,從而提高整個(gè)研究的效率。
[Abstract]:Objective to develop a central random distribution management system (web-based central randomization management system,WCRMS). Methods the whole system development process was divided into five stages: system planning, system analysis, system design, system implementation and system maintenance. The database is designed based on the International Association of Clinical data Exchange Standards (Clinical Data Interchange Standards Consortium,CDISC) standard. The model-view-controller (Model View Controller,MVC model is adopted. The web server adopts stable tomcat, database connection pool technology and Proxool.. Results We successfully developed the central random distribution management system, and after many tests, it is proved that the system is stable, reliable and real-time. At present, the system is running stably, it can support many research designs (multicenter / single center, blind method / non-blind), the clinical research of different sample size is carried out simultaneously, supports the blind research to expose the blindness urgently, the dynamic drug management. Conclusion the database design based on CDISC standard ensures the standardization and standardization of data and makes the system better connect with the electronic data acquisition EDC system. By using this system, the random allocation and hiding can be more reliable, and the project manager can monitor the progress of each sub-center of the project in real time, take corresponding measures, shorten the period of clinical research, and ensure the quality of the experiment. In order to improve the efficiency of the whole study.
【作者單位】： 廣州中醫(yī)藥大學(xué)第二附屬醫(yī)院;廣東省中醫(yī)院;廣州中醫(yī)藥大學(xué)DME中心;
【基金】：廣東省中醫(yī)藥局課題(20142060) 廣東省中醫(yī)院中醫(yī)藥科學(xué)技術(shù)研究專項(xiàng)課題(YN2015QN22)
【分類號(hào)】：TP315;R95

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