Institutional Review Board Infrastructure Development

波多黎各大学医学校区(MSC)建议开发一个技术基础设施，用于计算机跟踪研究方案、安全记录保留、电子方案提交，以促进机构审查委员会(IRB)的审查活动。基础设施将通过实施IRBWlSE提供。IRBWlSE由佐治亚理工学院研究所开发，是一个完全基于Web的IRB管理和跟踪工具，专为对人类参与者进行研究的机构而设计。目前，MSC有308个活动方案，平均执行54次全面审查，其中6次是新的 每次会议每年召开21次IRB业务人工执行成功完成将允许机构实现所有IRB业务的无纸化，还将提供收集重要统计数据的工具该计划的功能包括1)在线提交申请、续签和修改，包括支持文件，2)完成严重不良事件处理，3)在每个协议的整个生命周期内维护可审计的历史，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。海事局承诺在核准的预算期后为拟议方案的继续和维持提供资金。

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.