eIRB: Online Compliance Management System

密苏里-哥伦比亚大学（MU）正在实施一个自动化在线数据库系统（elRB），用于人类主题研究申请的提交、审查和跟踪。我们的目标是使用定制的系统来适当地管理和支持IRB活动，这些系统可以促进批准和质量控制过程，并且完全集成并利用本地信息体系结构。MU正在从一个已经变得不充分和不可靠的商业产品过渡到elRB系统，elRB有能力对通过Web输入的任何IRB活动进行排序、存储、更新和报告。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

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.