Technology for Electronic Submission of IRB Protocols

本申请代表杜兰大学对人类受试者研究增强奖计划(RFA OD-02-003)的机构响应。该奖项由美国国立卫生研究院设立，旨在为机构活动提供临时支持，以加强对接受NIH临床研究重大支持的机构的人类受试者研究的监督。这项申请的总体目标是获得技术开发奖，以进一步加强对IRB(机构审查委员会)职能的电子管理，包括初始协议提交、IRB审查员活动和IRB会议管理。我们计划与我们目前IRB软件的开发商ProlRB Plus，Inc.一起努力实现这一目标。杜兰健康科学IRB每年审查大约300项新方案、1000项杂项函件和1800份严重不良事件报告。ProlRB Plus，Inc.位于佛罗里达州坦帕市，是一家软件开发公司，在开发IRB专用软件方面经验丰富，目前在美国60多家机构使用。拟议中的合作将把杜兰的IRB和监管专业知识与ProlRB Plus公司的软件编程专业知识结合在一起。成功的合作将导致一种产品，该产品可以提供给其他研究机构，以加强IRB过程提供的保护。 具体目标：1.)与软件开发公司ProlRB Plus.合作 开发和测试ProlRB Plus电子管理软件的扩展功能。这个 扩大的能力将是：(A)允许调查人员向IRB在线提交新的协议；(B)允许IRB成员在线审查协议和相关通信；(C)允许IRB成员和授权调查人员在线查阅研究文件。2.)为所有IRB成员提供笔记本电脑，以便在会议期间，所有成员都可以在线访问学习文件、学习历史和评审员评论。

This application represents the institutional response from Tulane University to the Human Subjects Research Enhancements Award Program (RFA OD-02-003). This award was created by the NIH to provide interim support for institutional activities to strengthen oversight of human subjects research at institutions that receive significant NIH support for clinical research. The overall goal of this application is to obtain an award for development of technology to further enhance electronic management of IRB (Institutional Review Board) functions including initial protocol submission, IRB reviewer activities and IRB meeting management. We plan to work toward this goal in conjunction with ProlRB Plus, Inc., the developer of our current IRB software. The Tulane Health Sciences IRB reviews approximately 300 new protocols, 1000 items of miscellaneous correspondence and 1800 serious adverse event reports annually. ProlRB Plus, Inc., Tampa, FL is a software development company with experience in creating IRB-specific software which is currently in use at over 60 US institutions. The proposed collaboration will combine Tulane's IRB and regulatory expertise with the software programming expertise of ProlRB Plus., Inc. Successful collaboration will result in a product which can be made available to other research institutions for the purpose of strengthening protections offered by the IRB process. SPECIFIC AIMS: 1.) To collaborate with ProlRB Plus., a software development company, to develop and test expanded capatilities of the ProlRB Plus electronic management software. The expanded capabilities will be: (a) to allow online submission of new protocols from investigators to the IRB; (b) to allow online review of protocols and related correspondence by IRB members; (c) to allow online access to study files for IRB members and authorized investigators. 2.) To provide laptop computers for all IRB members so that during meetings, all members have online access to study documents, study history and reviewer comments.