Institutional Review Board Infrastructure Development

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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.