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<span style="margin:0px;font-family:Calibri, Helvetica, sans-serif;background-color:rgb(255, 255, 255)"><b>PROJECT OVERVIEW</b></span>
<div style="margin:0px;background-color:rgb(255, 255, 255)"><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">The Office of the Vice President for Research and Innovation (OVPRI) will be implementing a new Institutional Review Board (IRB)
module to support human subject research in early 2021. Additionally, as part of the IRB module, OVPRI will also be implementing a Human Research Protection Program (HRPP) toolkit that is made up of standard operating procedures (SOPs), checklists, templates,
worksheets, and more. These toolkit documents will be used in conjunction with the new IRB module.</span></div>
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<div style="margin:0px;background-color:rgb(255, 255, 255)"><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif"><b>PROJECT STATUS: </b>On-track</span></div>
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<div style="margin:0px;background-color:rgb(255, 255, 255)"><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif"><b>COMPLETED TASKS</b></span></div>
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<li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">July</span></li><ul>
<li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">The IRB project team completed a four-week onboarding process with the vendor to identify system requirements and business process changes required for implementation.</span></li><li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">The project team took a couple weeks to finalize the initial system requirements before sending them to the vendor for estimates.</span></li><li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">The vendor provided estimates for the system requirements.</span></li></ul>
<li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">August</span></li><ul>
<li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">The IRB project team met with the IRB Project Champions* to review and get feedback on the proposed system requirements and business process changes.</span></li><li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">The finalized system requirements were reviewed by the IRB Module Committee* and Program Committee governance groups and a final recommendation was made to the VPRI.</span></li><li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif"><i>*Information about the IRB Project Champions and IRB Module Committee can be found on the <a href="https://research.uoregon.edu/manage/research-administration-portal" title="https://research.uoregon.edu/manage/research-administration-portal" style="margin:0px">research
website</a> under the August 24 update.</i></span></li></ul>
<li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">September</span></li><ul>
<li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">VPRI approved the final system requirements.</span></li></ul>
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<div style="margin:0px;background-color:rgb(255, 255, 255)"><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif"><b>ONGOING TASKS</b></span></div>
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<li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">HRPP Toolkit</span></li><ul>
<li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">Beginning at the end of July, IRB staff started a more in-depth review of the HRPP toolkit documents to adapt them to UO policies and procedures. This review effort will continue over the
next several months.</span></li></ul>
<li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">IRB Module</span></li><ul>
<li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">Development and configuration started in September and will be completed in the next few weeks.</span></li></ul>
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<div style="margin:0px;background-color:rgb(255, 255, 255)"><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif"><b>UPCOMING TASKS</b></span></div>
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<li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">Next month, the IRB project team will begin planning and preparing for testing of the system and end user training.</span></li></ul>
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<div style="margin:0px;background-color:rgb(255, 255, 255)"><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif"><b>PROCESS CHANGES</b></span></div>
<div style="margin:0px;background-color:rgb(255, 255, 255)"><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">As with any new tool implementation, changes to business processes will be experienced. Each month, we’ll plan to share with you
upcoming changes you can expect with the new IRB module.</span></div>
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<li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">Initial Study Review</span></li><ul>
<li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">To initiate the initial study review process, an investigator will log into the IRB module and create a new study. The investigator will be prompted to complete a series of online forms
gathering information about their study and will upload their research plan and other study materials.</span></li><li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">When the investigator is ready to have their study reviewed by Research Compliance Services (RCS), they’ll submit it at the click of a button.</span></li><li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">Other exciting features that investigators can look forward to:</span></li><ul>
<li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">Initial study submissions can be started and saved allowing investigators to pick up where they left off at a future date.</span></li><li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">PI proxies can be assigned to a study submission allowing study team member(s) to submit on behalf of the PI.</span></li><li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">A primary contact can be assigned allowing someone on the study team to receive all study notifications and have read access to the study.</span></li><li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">Study submissions can be discarded, withdrawn, or copied.</span></li><li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">All documents uploaded with a submission are stored in the system and automatically versioned when a new copy is uploaded eliminating the need for investigators to keep their own copies
and versions.</span></li></ul>
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<li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">Next month we’ll share more information about the process used when RCS requests clarification or revisions.</span></li></ul>
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<div style="margin:0px;background-color:rgb(255, 255, 255)"><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif"><b>QUESTIONS/COMMENTS</b></span></div>
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<li><span style="margin:0px;font-family:Calibri, Helvetica, sans-serif">If you have any questions or comments about this project or the changes the new IRB module will introduce, please email rapinfo@uoregon.edu.</span></li></ul>
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