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<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif">Good afternoon Research Community,<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif">We are reaching out with some updates on the Performance Site Review (PSR) Process:<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif"><o:p> </o:p></span></p>
<ol style="margin-top:0in" start="1" type="1">
<li class="MsoNormal" style="mso-list:l0 level1 lfo1"><u><span style="font-family:"Calibri",sans-serif">Using Florence eBinders for qualifying clinical trials:<o:p></o:p></span></u></li></ol>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal"><b><span style="font-family:"Calibri",sans-serif">All studies conducted at UTSW which fulfill the
<a href="https://urldefense.com/v3/__https://grants.nih.gov/policy/clinical-trials/definition.htm__;!!MznTZTSvDXGV0Co!F1EJnC2FP6oR5TqHrrXKScK3y_dnTQTNpKjgoIdR609Pw699lWihOmejRnccocJWvwsHOO2Tk5SIxR-HGrl3yq66dj-NpxSPhAv0Hag$"><span style="color:#467886">NIH definition of a clinical trial</span></a> will now be required to use eFlorence or an alternative, equivalent eRegulatory system for storage of their regulatory
documents.</span></b><span style="font-family:"Calibri",sans-serif"> <o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif">The requirement for use of Florence for all studies that fulfill the definition of a clinical trial has been in place since the initiation of the Florence-Velos integration and was communicated
to study teams through our educational sessions, website and SOPs. We have however provided a grace period for this requirement as teams became familiar with the system.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal"><b><span style="font-family:"Calibri",sans-serif">Confirmation of eFlorence (or alternative eReg) use for qualifying clinical trials is now a required part of UTSW performance site review</span></b><span style="font-family:"Calibri",sans-serif">,
as study teams are growing increasingly familiar with the eFlorence system. <u>Qualifying studies will not receive Performance Site Approval without the use of an appropriate eRegulatory system.</u>
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif;mso-ligatures:none;mso-fareast-language:KO">Please find below for a link to the current OCR Policy related to eFlorence use:</span><span style="font-size:12.0pt;font-family:"Gulim",sans-serif;mso-ligatures:none;mso-fareast-language:KO"><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif;color:#156082;mso-ligatures:none;mso-fareast-language:KO"><a href="https://www.utsouthwestern.net/intranet/research/ocr/assets/sop-florence-001.pdf"><span style="color:#156082">sop-florence-001.pdf
(utsouthwestern.net)</span></a><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif">If you have any questions about this, please contact
<a href="mailto:OCR@utsouthwestern.edu"><span style="color:#467886">OCR@utsouthwestern.edu</span></a>
</span><span style="font-family:"Calibri",sans-serif;color:#156082;mso-ligatures:none;mso-fareast-language:KO"><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif"><o:p> </o:p></span></p>
<ol style="margin-top:0in" start="2" type="1">
<li class="MsoNormal" style="mso-list:l0 level1 lfo1"><u><span style="font-family:"Calibri",sans-serif">When and How to complete a Performance Site Modification:<o:p></o:p></span></u></li></ol>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif">Changes to study procedures or performance sites are not uncommon during the lifespan of a research study, when these happen a Performance Site Modification may be required in order to keep
details up to date. UTSW PS modifications need to be submitted for review and approval by the OCTM office when there has been
<b>a change or update to either a study related procedure or a location where the study takes place</b>.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif">Please find below for a link to a tip sheet outlining the PS Modification Process:<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif"><a href="https://www.utsouthwestern.net/intranet/research/ocr/assets/performace-site-modification-submission-tipsheet-v2.pdf"><span style="color:#467886">https://www.utsouthwestern.net/intranet/research/ocr/assets/performace-site-modification-submission-tipsheet-v2.pdf</span></a><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif">We will be hosting two virtual educational sessions outlining the new PS Modification Process, details can be found below:<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif">Thursday 13<sup>th</sup> June, 11-11:30am –
<a href="https://urldefense.com/v3/__https://teams.microsoft.com/l/meetup-join/19*3ameeting_ZTgxN2RjODktODA3Ni00NGQ2LTgzMGMtMjViOTc0MjQyYzMy*40thread.v2/0?context=*7b*22Tid*22*3a*229d418695-71ac-4c31-b5b2-c196c8ec3c8a*22*2c*22Oid*22*3a*223674f270-12e5-47bd-8135-31dd73d20a6a*22*7d__;JSUlJSUlJSUlJSUlJSUl!!MznTZTSvDXGV0Co!F1EJnC2FP6oR5TqHrrXKScK3y_dnTQTNpKjgoIdR609Pw699lWihOmejRnccocJWvwsHOO2Tk5SIxR-HGrl3yq66dj-NpxSPjyQw9UA$">
<span style="color:#467886">Link to join meeting</span></a><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif">Friday 21<sup>st</sup> June, 12-12.30pm –
<a href="https://urldefense.com/v3/__https://teams.microsoft.com/l/meetup-join/19*3ameeting_NWRiYmMyMWYtODI4OC00OTVkLTkzNzctMjhlZmRkZTlhODE2*40thread.v2/0?context=*7b*22Tid*22*3a*229d418695-71ac-4c31-b5b2-c196c8ec3c8a*22*2c*22Oid*22*3a*223674f270-12e5-47bd-8135-31dd73d20a6a*22*7d__;JSUlJSUlJSUlJSUlJSUl!!MznTZTSvDXGV0Co!F1EJnC2FP6oR5TqHrrXKScK3y_dnTQTNpKjgoIdR609Pw699lWihOmejRnccocJWvwsHOO2Tk5SIxR-HGrl3yq66dj-NpxSPVTHXRpo$">
<span style="color:#467886">Link to join meeting</span></a><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif">If you would like a calendar invite for either of these events, please email
<a href="mailto:OCR@utsouthwestern.edu"><span style="color:#467886">OCR@utsouthwestern.edu</span></a>
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif">If you have any questions about this, please contact
<a href="mailto:OCTM@UTSouthwestern.edu"><span style="color:#467886">OCTM@UTSouthwestern.edu</span></a>
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif;mso-ligatures:none;mso-fareast-language:KO">Please do not hesitate to reach out with any questions or if we can be of further support.
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family:"Calibri",sans-serif;mso-ligatures:none;mso-fareast-language:KO"><br>
Best wishes<o:p></o:p></span></p>
<p class="MsoNormal" style="background:white"><b><span style="font-family:"Calibri",sans-serif;color:black;mso-ligatures:none"><o:p> </o:p></span></b></p>
<p class="MsoNormal" style="background:white"><b><span style="font-family:"Calibri",sans-serif;color:black;mso-ligatures:none">Office of Clinical Research (OCR)</span></b><span style="font-family:"Calibri",sans-serif;color:black;mso-ligatures:none"> </span><span style="font-family:"Calibri",sans-serif;mso-ligatures:none"><o:p></o:p></span></p>
<p class="MsoNormal" style="background:white"><span style="font-family:"Calibri",sans-serif;color:black;mso-ligatures:none">UT Southwestern Medical Center </span><span style="font-family:"Calibri",sans-serif;mso-ligatures:none"><o:p></o:p></span></p>
<p class="MsoNormal" style="background:white"><span style="font-family:"Calibri",sans-serif;color:#0563C1;mso-ligatures:none"><a href="mailto:OCR@utsouthwestern.edu"><span style="color:#0563C1">OCR@utsouthwestern.edu</span></a></span><span style="font-family:"Calibri",sans-serif;color:black;mso-ligatures:none"> </span><span style="font-family:"Calibri",sans-serif;mso-ligatures:none"><o:p></o:p></span></p>
<p class="MsoNormal" style="background:white"><span style="font-family:"Calibri",sans-serif;color:#0563C1;mso-ligatures:none"><a href="https://www.utsouthwestern.net/intranet/research/ocr/"><span style="color:#0563C1">https://www.utsouthwestern.net/intranet/research/ocr/</span></a></span><span style="font-family:"Calibri",sans-serif;color:black;mso-ligatures:none"> </span><span style="font-family:"Calibri",sans-serif;mso-ligatures:none"><o:p></o:p></span></p>
<p class="MsoNormal"><o:p> </o:p></p>
<p class="MsoNormal"><o:p> </o:p></p>
<p class="MsoNormal"><o:p> </o:p></p>
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<p style="text-align:right"><span style="font-size:10pt;font-family:"Helvetica","sans-serif"; color:#666D70;">The future of medicine, today.</span></p>
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