This project will develop electronic support for the joint Institutional Review Board (IRB) recently established by Georgetown University and MedStar Research Institute for the review of oncology research. Once implemented for the Joint Oncology IRB, these electronic supports will be extended to the Georgetown University's three existing IRBs (two medical IRBs and one social-behavioral IRB). The project has two specific aims. (1) To develop a totally electronic IRB system that supports electronic submission of IRB protocol applications by investigators; routing of submitted protocols to IRB members; receipt of comments from IRB reviewers; transmission of modification requests to investigators; development of minutes of IRB meetings; tracking of protocol status; automatic notification to investigators of continuing review deadlines; and integration with existing electronic awards management record systems. (2) To develop an electronic adverse event (AE) reporting system that supports electronic submission of AE reports to the IRB; integration of AE reports with existing, electronic pharmacy records; facilitation of causation analysis; and automatic tran.smission of Serious Adverse Event (SAE) reports to Federal oversight, support, and funding agencies, including the US Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP). Effectiveness of the project activities will be evaluated through self-report user surveys that include both structured and open-ended questions.
