eIRB: Online Compliance Management System

eIRB：在线合规管理系统

• 批准号: 6591489
• 负责人: ROBERT Dickinson HALL
• 金额: $ 10万
• 依托单位: UNIVERSITY OF MISSOURI-COLUMBIA
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591489
• 关键词: Internet; computer assisted instruction; computer program /software; computer system design /evaluation; educational resource design /development; handbook; health science research analysis /evaluation; health science research support; information dissemination; online computer; training

The University of Missouri-Columbia (MU) is implementing an automated online database system (elRB) for human subject research application submission, review and tracking. Our goal is to properly manage and support IRB activities with customized systems that facilitate approval and quality control processes and that fully integrate with and exploit the local information architecture. MU is transitioning from a commercial product that has become inadequate and unreliable to the elRB system, elRB has the ability to sort, store, update, and report on any IRB activity entered via the Web. However, it does not yet support tracking and analysis of research activities such as applications, amendments, adverse events, deviations and continuing reviews. Fully developing elRB will take advantage of investments already made, including the knowledge and experience of our personnel, elRB can be integrated with other relevant University systems such as Exchange, Web-based IRB education and training modules, and the sponsored programs administration database. In this project, MU will expand and elaborate elRB to achieve four aims: Aim 1: Enhance the existing elRB and desktop application functionality Aim 2: Enhance and develop query and reporting functionalities of elRB Aim 3: Develop and publish documentation and manuals for the elRB Aim 4: Share the elRB with other universities The Interim Vice Provost for Research will lead a project development team comprised of the campus' two Compliance Officers, a Project Manager, a Programmer, and a technical consultant. This team will design the desktop query and reporting software and appropriate online processes for continuing review reports, amendments, deviation and adverse event reports, monitoring reports, collaborative institution forms, document loading, training, and review and tracking program features. Implementation will be iterative, incorporating user feedback throughout the project. New functionality will be released weekly for review. Each release will be tested and then released into production, with the ability to rollback to the former version immediately if need be. Based on interest expressed at a recent Midwest Consortium meeting, we have offered to give our program code to other universities free of charge and havealso extended an offer to accommodate customizations for other institutions on a cost recovery basis.

密苏里大学哥伦比亚分校(MU)正在实施一个自动化的在线数据库系统(ElRB)，用于提交、审查和跟踪人类主题研究申请。我们的目标是通过定制的系统适当地管理和支持IRB的活动，这些系统促进了审批和质量控制过程，并充分整合和利用了当地的信息架构。MU正在从一个已经变得不够充分和不可靠的商业产品过渡到elRB系统，elRB具有对通过Web输入的任何IRB活动进行分类、存储、更新和报告的能力。然而，它还不支持跟踪和分析研究活动，如申请、修订、不良事件、偏差和继续 评论。全面开发elRB将利用已经进行的投资，包括我们人员的知识和经验，elRB可以与其他相关大学系统集成，如Exchange、基于Web的IRB教育和培训模块以及赞助项目管理数据库。在这个项目中，MU将扩展和细化elRB，以实现四个目标： 目标1：增强现有的elRB和桌面应用程序功能 目标2：加强和发展elRB的查询和报告功能 目标3：为elRB编写和出版文件和手册 目标4：与其他大学共享elRB 负责研究的临时副教务长将领导一个项目开发团队，该团队由园区的两名合规官员、一名项目经理、一名程序员和一名技术顾问组成。该团队将设计桌面查询和报告软件以及适当的在线流程，用于持续审查报告、修订、偏差和不良事件报告、监测报告、协作机构表格、文件加载、培训以及审查和跟踪计划功能。 实施将是迭代的，在整个项目中纳入用户反馈。新功能将每周发布一次以供审查。每个版本都将经过测试，然后发布到生产中，如果需要，可以立即回滚到以前的版本。基于最近中西部联盟会议上表达的兴趣，我们提出将我们的项目代码免费提供给其他大学，并在收回成本的基础上延长了对其他机构的定制。