基于Web的EDC系统的设计与构建策略

发布时间：2018-11-06 21:19

【摘要】：背景:临床试验是验证新药(包括器械及体外诊断试剂等)的有效性和安全性必不可少的步骤,而通常临床试验及其预实验是一个周期相对较长且花费较高的过程,这是因为传统的临床试验会使用纸质的病例报告表来记录和收集受试者的临床试验数据,数据管理人员不仅需要对纸质的数据进行双盲录入,还需要在录入过程中不断地和试验中心的人员进行沟通以完成数据正确性和完整性的核查。所以纸质病例报告表这一形式往往会造成数据录入及其后续统计分析的滞后,而且数据的有效性、正确性和完整性也往往得不到有效地保证,这会大大增加整个试验的周期和开支。随着互联网信息技术的发展,EDC(Electronic Data Capture)系统在临床试验中的使用不仅提高了数据收集的质量,还节省了试验进行所需的成本和开销,最终缩短了临床试验的进行周期。目的:本文旨在为开发一款EDC系统提出构建的思路与策略,该系统基于Web实现,且具有试验设计、数据录入、核查、质疑管理、稽查留痕、电子签名与用户权限管理等常用功能,并符合具体法规和行业标准。本文针对其中的一些难点和关键点加以说明和讨论,特别是用户角色权限控制、实验设计中的eCRF构建及其数据库设计等方面,都是EDC系统开发中一定会面临的难点和挑战。方法:我们在文章第一部分首先整理并介绍了 EDC系统构建时所需的一些主要的信息化技术,如用作访问请求回应的网页服务器、用作动态响应及逻辑处理的服务器端脚本、储存数据的数据库服务、数据传递标准化和eCRF视图储存的XML技术、用于提供良好的用户交互的前端界面设计、以及临床试验必不可少的数据安全与备份技术等方面;然后在第二部分中根据不同功能的具体需求,并结合相关法规(如我国的国家食品药品监督管理总局(CFDA)发布的临床试验的电子数据采集技术指导原则、美国的FDA的21 CFR Part11法令等)和行业标准(如CDISC等),为EDC系统的构建提出了相应的策略和实施办法。结论:EDC系统是一个典型的信息化系统,因此整个过程不能一蹴而就,要在对每一个具体功能都进行了精准分析的前提下,对需求的各个方面都做到有效耦合关联的情况下,才能开发出一套合规的、完整的、用户友善的EDC系统。因此,在EDC系统的实际开发中,除了要考虑本文提到的这些信息化技术的应用和具体法规要求而外,还需要考虑诸如用户需求沟通、系统开发周期、系统安装实测以及综合成本等各项因素。
[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.
【学位授予单位】：南方医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R95

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