HIRBERT: Harvard IRB Electronic Reporting Tool

HIRBERT：哈佛 IRB 电子报告工具

• 批准号: 6591387
• 负责人: STEVEN E. HYMAN
• 金额: $ 25万
• 依托单位: HARVARD MEDICAL SCHOOL
• 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/6591387
• 关键词: computer system design /evaluation; data management; experimental designs; health science research analysis /evaluation; health science research support; online computer

The primary objective of this project is development of an Institutional Review Board (IRB) process management system -- HIRBERT: Harvard IRB Electronic Reporting Tool -- with a common technology platform that will serve the University's three independent IRB's by facilitating and automating the protocol approval process. We envision HIRBERT as a highly flexible multi-user system that will replace three stand alone legacy systems. Development of a single system will allow for standardization of IRB data across the University without sacrificing the distinct needs of each office. It will also allow for a coordination of IRB activity not previously available. At the conclusion of the project HIRBERT will support and enable an automated approval process; allow for direct entry of application and renewal data by IRB administrative staff; support and enable agenda, minutes, letters and notification templates; strengthen and streamline the continuing review process; and link compliance and IRB processes. It will provide the IRB offices with the ability to meet University, study, investigator and sponsor reporting needs and current and anticipated federal reporting requirements. HIRBERT will provide the University with an infrastructure upon which to build a Web-based electronic protocol submission process for investigators. It will greatly reduce the burdensome administrative demands on the IRB staff thereby enabling them to devote more attention to substantive protection issues.

该项目的主要目标是开发机构审查委员会 (IRB) 流程管理系统 - HIRBERT：哈佛 IRB 电子报告工具 - 以及一个通用技术平台，该平台将通过促进和自动化协议批准流程来为大学的三个独立 IRB 提供服务。我们设想 HIRBERT 是一个高度灵活的多用户系统，将取代三个独立的遗留系统。单一系统的开发将允许整个大学的 IRB 数据标准化，而不会牺牲每个办公室的独特需求。它还将允许协调以前无法实现的 IRB 活动。项目结束时，HIRBERT 将支持并启用自动化审批流程；允许 IRB 行政人员直接输入申请和更新数据 职员;支持并启用议程、会议记录、信件和通知模板；加强和简化持续审查流程；并将合规性和IRB流程联系起来。它将使 IRB 办公室能够满足大学、研究、调查员和赞助商的报告需求以及当前和预期的联邦报告要求。 HIRBERT 将为大学提供基础设施，为调查人员建立基于网络的电子协议提交流程。它将大大减轻IRB工作人员繁重的行政要求，从而使他们能够将更多的精力投入到实质性保护问题上。