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一个基于NoSQL文档的eCRF系统,用于研究具有可变不良事件的疫苗,研究COVID19疫苗的病例研究

Seyyed Hamzeh Nasiri Khoshroudi¹, Ali Asghar Safaei², Hoorieh Soleimanjahi³

¹Department of Medical Informatics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.

Scientific reports

|July 2, 2025

概括

本研究引入了一种以文档为导向的NoSQL系统,用于管理来自药物和疫苗研究的各种不良事件数据,例如COVID-19疫苗. 该系统为收集和分析复杂,非结构化数据提供了更好的性能和灵活性.

科学领域:

计算机科学计算机科学
医疗信息学医疗信息学
数据管理数据管理

背景情况:

结构化数据库与来自药物/疫苗研究的非结构化不良事件数据作斗争.
NoSQL,特别是以文档为导向的模型,适合处理这种可变数据.
电子案例报告表 (eCRF) 需要灵活的数据模型.

研究的目的:

开发和评估药物干预研究报告系统,对药物干预研究的不良事件具有很高的变异性.
使用基于文档的NoSQL模型,高效地管理结构化和非结构化数据.
创建一个灵活,快速和高效的系统来收集和分析药物/疫苗不良事件数据,特别是COVID-19疫苗.

主要方法:

应用描述性研究方法.
使用软件要求规范 (SRS) 标准定义的系统要求.
基于Web的系统的原型开发,使用用户体验问卷 (UEQ) 和应用安全验证标准 (ASVS) 进行评估.
在MongoDB (以文档为导向) 和SQL Server (关系型) 之间进行比较性能分析.

主要成果:

该系统获得了2.31的平均用户体验分数,位居前10%的结果中.
确定了有效的安全控制,尽管会议管理和身份验证需要改进.
与关系模型相比,面向文档的NoSQL模型在响应时间和非结构化数据管理方面表现出优异的性能.

结论:

与eCRF结合的以文档为导向的数据模型对于在干预研究中收集基本数据是有效的,特别是在COVID-19疫苗等药物副作用方面.
开发的系统提供了一种灵活而精确的方法来管理可变和可能未知的不良事件数据.
该系统的可用性和安全性评估表明其潜在的有效性,并提出了改善外部系统集成的建议.

关键词:

基于文件的基于文件的文件.电子案例报告表 (ECRF) 是一种电子案例报告表.信息系统的设计信息系统的设计这是一个NoSQL数据模型.软件开发软件开发疫苗的副作用疫苗的副作用

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