Institutional Review Board Infrastructure Development

波多黎各大学医学科学校区（MSC）提议开发一种技术基础设施，用于计算机跟踪研究协议、安全记录保存、电子协议提交以促进机构审查委员会（IRB）审查活动的基础设施将由IRBWlSE的实施提供。IRBWlSE由佐治亚理工学院研究所开发，是一个完全基于网络的IRB管理和跟踪工具，设计用于对人类参与者进行研究的机构。目前，MSC有308个有效协议，执行平均54个完整审查，其中6个是新的

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.