【摘要】：背景:臨床試驗(yàn)是驗(yàn)證新藥(包括器械及體外診斷試劑等)的有效性和安全性必不可少的步驟,而通常臨床試驗(yàn)及其預(yù)實(shí)驗(yàn)是一個(gè)周期相對(duì)較長(zhǎng)且花費(fèi)較高的過(guò)程,這是因?yàn)閭鹘y(tǒng)的臨床試驗(yàn)會(huì)使用紙質(zhì)的病例報(bào)告表來(lái)記錄和收集受試者的臨床試驗(yàn)數(shù)據(jù),數(shù)據(jù)管理人員不僅需要對(duì)紙質(zhì)的數(shù)據(jù)進(jìn)行雙盲錄入,還需要在錄入過(guò)程中不斷地和試驗(yàn)中心的人員進(jìn)行溝通以完成數(shù)據(jù)正確性和完整性的核查。所以紙質(zhì)病例報(bào)告表這一形式往往會(huì)造成數(shù)據(jù)錄入及其后續(xù)統(tǒng)計(jì)分析的滯后,而且數(shù)據(jù)的有效性、正確性和完整性也往往得不到有效地保證,這會(huì)大大增加整個(gè)試驗(yàn)的周期和開(kāi)支。隨著互聯(lián)網(wǎng)信息技術(shù)的發(fā)展,EDC(Electronic Data Capture)系統(tǒng)在臨床試驗(yàn)中的使用不僅提高了數(shù)據(jù)收集的質(zhì)量,還節(jié)省了試驗(yàn)進(jìn)行所需的成本和開(kāi)銷,最終縮短了臨床試驗(yàn)的進(jìn)行周期。目的:本文旨在為開(kāi)發(fā)一款EDC系統(tǒng)提出構(gòu)建的思路與策略,該系統(tǒng)基于Web實(shí)現(xiàn),且具有試驗(yàn)設(shè)計(jì)、數(shù)據(jù)錄入、核查、質(zhì)疑管理、稽查留痕、電子簽名與用戶權(quán)限管理等常用功能,并符合具體法規(guī)和行業(yè)標(biāo)準(zhǔn)。本文針對(duì)其中的一些難點(diǎn)和關(guān)鍵點(diǎn)加以說(shuō)明和討論,特別是用戶角色權(quán)限控制、實(shí)驗(yàn)設(shè)計(jì)中的eCRF構(gòu)建及其數(shù)據(jù)庫(kù)設(shè)計(jì)等方面,都是EDC系統(tǒng)開(kāi)發(fā)中一定會(huì)面臨的難點(diǎn)和挑戰(zhàn)。方法:我們?cè)谖恼碌谝徊糠质紫日聿⒔榻B了 EDC系統(tǒng)構(gòu)建時(shí)所需的一些主要的信息化技術(shù),如用作訪問(wèn)請(qǐng)求回應(yīng)的網(wǎng)頁(yè)服務(wù)器、用作動(dòng)態(tài)響應(yīng)及邏輯處理的服務(wù)器端腳本、儲(chǔ)存數(shù)據(jù)的數(shù)據(jù)庫(kù)服務(wù)、數(shù)據(jù)傳遞標(biāo)準(zhǔn)化和eCRF視圖儲(chǔ)存的XML技術(shù)、用于提供良好的用戶交互的前端界面設(shè)計(jì)、以及臨床試驗(yàn)必不可少的數(shù)據(jù)安全與備份技術(shù)等方面;然后在第二部分中根據(jù)不同功能的具體需求,并結(jié)合相關(guān)法規(guī)(如我國(guó)的國(guó)家食品藥品監(jiān)督管理總局(CFDA)發(fā)布的臨床試驗(yàn)的電子數(shù)據(jù)采集技術(shù)指導(dǎo)原則、美國(guó)的FDA的21 CFR Part11法令等)和行業(yè)標(biāo)準(zhǔn)(如CDISC等),為EDC系統(tǒng)的構(gòu)建提出了相應(yīng)的策略和實(shí)施辦法。結(jié)論:EDC系統(tǒng)是一個(gè)典型的信息化系統(tǒng),因此整個(gè)過(guò)程不能一蹴而就,要在對(duì)每一個(gè)具體功能都進(jìn)行了精準(zhǔn)分析的前提下,對(duì)需求的各個(gè)方面都做到有效耦合關(guān)聯(lián)的情況下,才能開(kāi)發(fā)出一套合規(guī)的、完整的、用戶友善的EDC系統(tǒng)。因此,在EDC系統(tǒng)的實(shí)際開(kāi)發(fā)中,除了要考慮本文提到的這些信息化技術(shù)的應(yīng)用和具體法規(guī)要求而外,還需要考慮諸如用戶需求溝通、系統(tǒng)開(kāi)發(fā)周期、系統(tǒng)安裝實(shí)測(cè)以及綜合成本等各項(xiàng)因素。
[Abstract]:Background: clinical trials are essential steps to verify the efficacy and safety of new drugs, including instruments and in vitro diagnostic reagents, while clinical trials and their pretrials are usually a relatively long and costly process. This is because traditional clinical trials use paper case reports to record and collect clinical trial data, and data managers not only have to do double-blind input of paper data. There is also a need for continuous communication with test center personnel during the entry process to complete data correctness and completeness verification. Therefore, the form of paper case report forms often leads to the lag of data entry and subsequent statistical analysis, and the validity, correctness and completeness of the data are often not effectively guaranteed. This will greatly increase the cycle and cost of the experiment. With the development of Internet information technology, the use of, EDC (Electronic Data Capture) system in clinical trials not only improves the quality of data collection, but also saves the cost and expense of the trials, and finally shortens the cycle of clinical trials. Objective: the purpose of this paper is to develop a EDC system based on Web, which is based on Web, and has experimental design, data entry, verification, query management, check marks. Electronic signature and user rights management and other common functions, and comply with specific regulations and industry standards. In this paper, some difficulties and key points are explained and discussed, especially the user role privilege control, eCRF construction and database design in experimental design, all of which are the difficulties and challenges in the development of EDC system. Methods: in the first part of the article, we first organize and introduce some of the main information technologies needed to build the EDC system, such as the web server used for accessing request response, the server-side script for dynamic response and logic processing. Database service for storing data, XML technology for data transfer standardization and eCRF view storage, used to provide good user interaction front-end interface design, as well as necessary data security and backup technology for clinical trials, etc. Then in the second part, according to the specific needs of different functions, and combining the relevant laws and regulations (such as the (CFDA) issued by the State Administration of Food and Drug Administration of China, the guidelines of electronic data acquisition technology for clinical trials, The 21 CFR Part11 Act of FDA and the industry standard (such as CDISC etc.) in the United States put forward the corresponding strategies and implementation methods for the construction of EDC system. Conclusion: EDC system is a typical information system, so the whole process can not be accomplished overnight. To develop a compliant, complete, user-friendly EDC system. Therefore, in the actual development of EDC system, in addition to the application of these information technology mentioned in this paper and the specific requirements of laws and regulations, we also need to consider such as user needs communication, system development cycle, System installation test and comprehensive cost and other factors.
【學(xué)位授予單位】：南方醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R95

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