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<b><span style="color:black; border:none windowtext 1.0pt; padding:0in; background:white">PROJECT BACKGROUND</span></b> </p>
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<span style="color:black; border:none windowtext 1.0pt; padding:0in">In late January 2021, the Office of the Vice President for Research and Innovation (OVPRI) will implement the Institutional Review Board (IRB) module of the research administration portal
(RAP) for the support human of subjects research.</span><span style="color:black"> </span></p>
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<b><span style="color:black; border:none windowtext 1.0pt; padding:0in">PROJECT STATUS:
</span></b><span style="color:black; border:none windowtext 1.0pt; padding:0in">On-track</span><span style="color:black"> </span></p>
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<b><span style="color:black; border:none windowtext 1.0pt; padding:0in">COMPLETED TASKS</span></b><span style="color:black"> </span></p>
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<span style="border:none windowtext 1.0pt; padding:0in">October</span><span style=""> </span></li><ul type="circle" style="margin-bottom:0in">
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<span style="border:none windowtext 1.0pt; padding:0in">The IRB project team completed development and configuration of the IRB module at the end of October.</span><span style=""> </span></li></ul>
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<b><span style="color:black; border:none windowtext 1.0pt; padding:0in">CURRENT TASKS</span></b><span style="color:black"> </span></p>
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<span style="border:none windowtext 1.0pt; padding:0in">HRPP Toolkit*</span><span style=""> </span></li><ul type="circle" style="margin-bottom:0in">
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<span style="border:none windowtext 1.0pt; padding:0in">Staff continue to review toolkit documents.</span><span style=""> </span></li><li class="MsoNormal" style="margin:0in; font-size:12pt; font-family:Calibri,sans-serif; color:black; mso-list:l5 level2 lfo2; background:white">
<i><span style="border:none windowtext 1.0pt; padding:0in">*The toolkit 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></i></li></ul>
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<span style="border:none windowtext 1.0pt; padding:0in">IRB Module Testing</span><span style=""> </span></li><ul type="circle" style="margin-bottom:0in">
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<span style="">The project team is currently conducting user acceptance testing (UAT) with faculty, staff, and IRB committee members. </span></li><li class="MsoNormal" style="margin:0in; font-size:12pt; font-family:Calibri,sans-serif; color:black; mso-list:l5 level2 lfo2; background:white">
<span style="">UAT is a type of testing that is performed by end users to verify that the system operates as expected before moving the system into the production environment. Its purpose is to validate the end-to-end business flow by walking through real-world
scenarios, to identify any issues that need to be corrected prior to go-live and help inform training. </span></li><li class="MsoNormal" style="margin:0in; font-size:12pt; font-family:Calibri,sans-serif; color:black; mso-list:l5 level2 lfo2; background:white">
<span style="">UAT started on November 9 and will run until November 24. </span></li></ul>
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<span style="">Training </span></li><ul type="circle" style="margin-bottom:0in">
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<span style="">Training will be offered to the research community in December and January prior to the IRB module going live. Research Compliance Services (RCS) will host a series of information sessions in December and workshops in January where investigators
and research staff can learn how to use the IRB module for new protocol submissions. </span></li><li class="MsoNormal" style="margin:0in; font-size:12pt; font-family:Calibri,sans-serif; color:black; mso-list:l5 level2 lfo2; background:white">
<span style="">The project team is still in the planning phase for training and working to identify exact dates. More information will be shared with the community soon. </span></li></ul>
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<b><span style="color:black; border:none windowtext 1.0pt; padding:0in">UPCOMING TASKS</span></b><span style="color:black"> </span></p>
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<span style="border:none windowtext 1.0pt; padding:0in">Confirm training dates and communicate with the research community and staff.</span><span style=""> </span></li></ul>
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<b><span style="color:black; border:none windowtext 1.0pt; padding:0in">PROCESS CHANGES</span></b><span style="color:black"> </span></p>
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<span style="color:black; border:none windowtext 1.0pt; padding:0in">As with any new tool implementation, changes to business processes will be experienced. Each month, we will share upcoming changes you can expect with the IRB module.
<i>Note: if you are new to this email list and would like a copy of our previous communications, contact Kelsey Lunsmann at kdavis2@uoregon.edu.</i></span><span style="color:black"> </span></p>
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<span style="border:none windowtext 1.0pt; padding:0in">Clarifications or revisions requested by RCS or the IRB</span><span style=""> </span></li><ul style="margin-bottom:0in">
<li>After you submit your study to RCS, a Research Compliance Administrator or the IRB may have follow-up questions or request additional information to aid in the review process. There also may be revisions required to secure IRB approval. The request for
additional information/required revisions can happen during pre-review, IRB review (either by a designated reviewer or an IRB committee member), or post-review. </li><li>When clarifications or revisions are requested you will receive an email notification. </li><ul style="margin-bottom:0in">
<li><i>If modifications are required to secure approval, you will also receive a formal letter with the notification detailing the required modifications. </i></li></ul>
<li>To view the notification and make changes to the submission you will: </li></ul>
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<span style="">Log into the IRB module. </span></li><li class="MsoNormal" style="margin:0in; font-size:12pt; font-family:Calibri,sans-serif; color:black; mso-list:l1 level3 lfo6; background:white">
<span style="">Respond to the request in the IRB module. During this time, your study will be editable to allow for changes to the submission. </span></li><li class="MsoNormal" style="margin:0in; font-size:12pt; font-family:Calibri,sans-serif; color:black; mso-list:l1 level3 lfo6; background:white">
<span style="">Submit your response directly through the IRB module. </span></li></ol>
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<span style="border:none windowtext 1.0pt; padding:0in">Next month we will share information about the approval process.</span><span style=""> </span></li></ul>
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<b><span style="color:black; border:none windowtext 1.0pt; padding:0in">QUESTIONS/COMMENTS</span></b><span style="color:black"> </span></p>
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<span style="border:none windowtext 1.0pt; padding:0in">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><span style=""> </span></li></ul>
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