Development of an Open Source Research Management System

开源研究管理系统的开发

• 批准号: 7536213
• 负责人: KENNETH E FREEDLAND
• 金额: $ 9.83万
• 依托单位: MRH CONSULTING SERVICES, LLC
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-18 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7536213
• 关键词: Adopted; Algorithms; Architecture; Archives; Area; Behavioral; Budgets; Businesses; Classification; Client; Clinical; Clinical Investigator; Clinical Research; Clinical Research Protocols; Clinical Trials; Clinical Trials Design; Collaborations; Collection; Communities; Complex; Computer software; Data; Data Collection; Data Security; Databases; Development; Documentation; Drug Industry; Electronics; Ensure; Essential Drugs; Fostering; Foundations; Funding; Future; Goals; Grant; Health Insurance Portability and Accountability Act; Health behavior; Informatics; Institutes; Internet; Intervention Trial; Laboratories; Laboratory Research; Logic; Medical; Metadata; Minority; National Center for Research Resources; Observational Study; Online Systems; Operations Research; Operative Surgical Procedures; Output; Paper; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Principal Investigator; Productivity; Protocols documentation; Public Health; Purpose; Randomized Clinical Trials; Range; Reporting; Research; Research Design; Research Personnel; Research Project Grants; Research Training; Resources; SAS; Score; Services; Side; Site; Small Business Technology Transfer Research; Software Tools; Sorting - Cell Movement; Standards of Weights and Measures; System; Testing; Training; Training Support; Translational Research; United States; United States National Institutes of Health; Work; analytical tool; base; clinical research site; computerized data processing; cost; data integrity; design; improved; interest; open source; payment; programs; tool; transmission process

DESCRIPTION (provided by applicant): The pharmaceutical industry has access to well-designed clinical trial management software (CTMS) for their studies. Specialized CTMS packages are essential for drug trials but are not optimal for other kinds of clinical research, such as observational, epidemiological, and mechanistic studies, nonpharmacological intervention trials, health behavior research, etc. Researchers who work in these areas need software that is flexible enough to accommodate an unlimited variety of clinical research protocols. Because no suitable software packages were available for this type of clinical research operation, we developed a web-based clinical research management system for our own studies. It quickly became an indispensable tool for our clinical research laboratory. We are currently using it to manage two large, NIH-funded clinical studies, as well as smaller projects. Many other clinical researchers need similar software. However, the present system was designed specifically for the developers' own laboratory, not for dissemination. The purpose of this Phase I STTR application is to redesign this software to prepare it for dissemination as a scalable, open source application, and to perform systematic alpha and unit testing to confirm its technical feasibility. The system has numerous features that will make it especially useful for academic clinical research laboratories. These include web-based and integrated remote data collection via dual-use (electronic data capture [EDC] and paper) forms; analysis and reporting utilities to support operational study management; study document and media management capabilities; and tools to facilitate sharing of analytical programs, data, and analytical outputs among researchers in an organized and permissions-based manner. The system's EDC facility enables research teams create complex, intelligent, dual-use forms containing data integrity constraints, skip logic, and scoring algorithms, and applies this information both to the forms and to the research database. It includes numerous data integrity, data security, and HIPAA compliance features, and supports online data collection, as well as offline data collection through a separate, integrated, client-side application. For reporting and analysis functions, the application is bundled with a powerful, open source statistical application, and it also provides seamless connectivity to SAS. The application is database-agnostic and fully scalable. This will enable it to serve the needs of small research labs utilizing a single, self-contained installation, as well as larger laboratories and multicenter collaborations that may utilize multiple application servers through a distributed, web services-based architecture. The application facilitates EDC, reporting, and operational management for labs with limited technical resources, while exposing the full power of underlying software tools for labs with access to technical staff. The small business concern will provide training, customization, and support services for users. PUBLIC HEALTH RELEVANCE: This is a proposal to prepare a clinical research management software package for dissemination. Unlike other software packages that are designed exclusively for pharmaceutical trials, this system is designed to support a wide variety of clinical research protocols. It is expected to improve the productivity and cost-efficiency of clinical research operations, and to help research teams meet high standards for data integrity, data security, and HIPAA compliance.

描述(申请人提供)：制药行业可以使用设计良好的临床试验管理软件(CTMS)进行研究。专门的CTMS软件包对于药物试验是必不可少的，但对于其他类型的临床研究并不是最佳的，例如观察性、流行病学和机械性研究、非药物干预试验、健康行为研究等。在这些领域工作的研究人员需要足够灵活的软件来适应无限种类的临床研究方案。由于没有适合这种类型的临床研究操作的软件包，我们为自己的研究开发了一个基于Web的临床研究管理系统。它很快成为我们临床研究实验室不可或缺的工具。我们目前正在使用它管理两个由NIH资助的大型临床研究，以及较小的项目。许多其他临床研究人员也需要类似的软件。然而，目前的系统是专门为开发人员自己的实验室设计的，而不是为了传播。第一阶段STTR应用程序的目的是重新设计该软件，准备将其作为可扩展、开放源码的应用程序进行传播，并执行系统的阿尔法和单元测试，以确认其技术可行性。 该系统具有许多功能，将使其对学术临床研究实验室特别有用。其中包括通过两用(电子数据捕获[EDC]和纸质)表格进行的基于网络的集成远程数据收集；支持操作研究管理的分析和报告实用程序；研究文件和媒体管理能力；以及促进以有组织和基于许可的方式在研究人员之间共享分析程序、数据和分析结果的工具。该系统的EDC设施使研究团队能够创建包含数据完整性约束、跳过逻辑和评分算法的复杂、智能的两用表单，并将这些信息应用于表单和研究数据库。它包括多种数据完整性、数据安全性和HIPAA合规性功能，并支持通过独立、集成的客户端应用程序进行在线数据收集和离线数据收集。对于报告和分析功能，该应用程序与一个强大的开源统计应用程序捆绑在一起，它还提供了与SAS的无缝连接。该应用程序与数据库无关，并且完全可扩展。这将使其能够满足使用单一、独立安装的小型研究实验室的需求，以及可能通过分布式、基于网络服务的架构利用多个应用服务器的大型实验室和多中心协作的需求。该应用程序方便了技术资源有限的实验室的EDC、报告和运营管理，同时向实验室展示了底层软件工具的全部功能，并允许技术人员访问。这家小型企业将为用户提供培训、定制和支持服务。 公共卫生相关性：这是一项准备临床研究管理软件包以供传播的建议。与专门为药物试验设计的其他软件包不同，该系统旨在支持各种临床研究方案。预计它将提高临床研究操作的生产率和成本效益，并帮助研究团队满足数据完整性、数据安全性和HIPAA合规性的高标准。