Institutional Review Board Infrastructure Development

机构审查委员会基础设施发展

• 批准号: 6591175
• 负责人: Jose R. Carlo
• 金额: $ 15万
• 依托单位: UNIVERSITY OF PUERTO RICO MED SCIENCES
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-12 至 2003-09-11
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6591175
• 关键词: Internet; automated health care system; computer program /software; computer system design /evaluation; health science research support; informatics; information system analysis; information systems

The Medical Sciences Campus (MSC) of the University of Puerto Rico proposes to develop a technology infrastructure for computer tracking of research protocols, secure record retention, electronic protocol submission to facilitate institutional Review Board's (IRB) review activities The infrastructure will be provided by the implementation of IRBWlSE The IRBWlSE developed by Georgia Tech Research institute is a completely web based IRB management and tracking tool designed for use in institutions conducting research on human participants Currently, the MSC has 308 active protocols, performs an average of 54 full reviews of which 6 are new in each meeting There are 21 convened meetings per year IRB business is performed manually Successful completion will allow the institution to go paperless on all IRB business and will also provide the tool for gathering of vital statistics Among the features of the program are 1) online submision of applications, renewals, and modifications, including supporting documents, 2) Complete serious adverse events processing, 3) Maintenance of auditable history for the full lifetime of every protocol, and, 4) Online maintenance of IRB meeting agendas and meetings The proposed project will be fully implemented in twelve months The MSC is committed to provide the funds for the continuation and maintenance of the proposed program after the approved budget period.

波多黎各大学医学院（MSC）提议开发一种技术基础设施，用于计算机跟踪研究方案，安全记录保留，电子方案提交，以便于机构审查委员会（IRB）审查活动IRBWlSE的实施将提供基础设施。IRBWlSE由格鲁吉亚技术研究所开发，是一种完全基于网络的IRB管理和跟踪工具目前，MSC有308个活动协议，平均执行54个全面审查，其中6个是新的， 每次会议每年召开21次会议，IRB业务由人工执行。成功完成将允许机构在所有IRB业务上无纸化，还将提供收集生命统计数据的工具。该计划的特点是：1）在线提交申请、更新和修改，包括支持文件，2）完成严重不良事件处理，3）在每个方案的整个生命周期内维护可稽查的历史记录，以及4）在线维护IRB会议议程和会议 拟议的项目将在12个月内全面实施。海安会承诺在核定预算期后提供资金，继续和维持拟议的项目。