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<p class="MsoNormal"><b><span style="font-size:12.0pt;color:#1D1D1D">IBIS Week In Review</span></b><o:p></o:p></p>
<p class="MsoNormal" style="caret-color: rgb(0, 0, 0)"><b><span style="font-size:12.0pt">7/14<span style="color:#1D1D1D">/2023</span></span></b><o:p></o:p></p>
<p class="MsoNormal"><span style="font-size:11.0pt"> </span><o:p></o:p></p>
<blockquote style="margin-left:30.0pt;margin-top:5.0pt;margin-right:0in;margin-bottom:5.0pt">
<p class="MsoNormal" style="caret-color: rgb(0, 0, 0)"><b><span style="font-size:11.0pt">IBIS DS IBR Approval</span></b><o:p></o:p></p>
<p class="MsoNormal" style="margin-left:42.0pt"><span style="font-size:11.0pt">A new DS modification has been approved and the following has been sent to each site:<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:0in;margin-right:0in;margin-bottom:5.0pt;margin-left:78.0pt;text-indent:-.25in;mso-list:l0 level1 lfo1">
<![if !supportLists]><span style="font-size:11.0pt"><span style="mso-list:Ignore">1.<span style="font:7.0pt "Times New Roman"">
</span></span></span><![endif]><b><span style="font-size:11.0pt">DS/control verbal consent</span></b><span style="font-size:11.0pt"> - updated with additional information about the purpose of the study and to reflect LEAP questionnaires as part of the verbal
consent process<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:0in;margin-right:0in;margin-bottom:5.0pt;margin-left:78.0pt;text-indent:-.25in;mso-list:l0 level1 lfo1">
<![if !supportLists]><span style="font-size:11.0pt"><span style="mso-list:Ignore">2.<span style="font:7.0pt "Times New Roman"">
</span></span></span><![endif]><b><span style="font-size:11.0pt">DS informed consent </span></b><span style="font-size:11.0pt">- updated to include texting as well as email - IRB now requiring participants to mark their initials on the consent indicating permission
for text and email - please make sure this is filled out<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:0in;margin-right:0in;margin-bottom:5.0pt;margin-left:78.0pt;text-indent:-.25in;mso-list:l0 level1 lfo1">
<![if !supportLists]><span style="font-size:11.0pt"><span style="mso-list:Ignore">3.<span style="font:7.0pt "Times New Roman"">
</span></span></span><![endif]><b><span style="font-size:11.0pt">LEAP Child Exposure form and LEAP Adult proficiency form</span></b><span style="font-size:11.0pt"> - these forms have been added to the screening call and should be completed along with the TSI
and SCQ/M-CHAT. They must be completed on all subjects, even if they only speak one language. <o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:0in;margin-right:0in;margin-bottom:5.0pt;margin-left:78.0pt;text-indent:-.25in;mso-list:l0 level1 lfo1">
<![if !supportLists]><span style="font-size:11.0pt"><span style="mso-list:Ignore">4.<span style="font:7.0pt "Times New Roman"">
</span></span></span><![endif]><b><span style="font-size:11.0pt">Control TSI</span></b><span style="font-size:11.0pt"> - updated to reflect current exclusion criteria and the addition of the LEAP measures to the screening call.<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:0in;margin-right:0in;margin-bottom:5.0pt;margin-left:78.0pt;text-indent:-.25in;mso-list:l0 level1 lfo1">
<![if !supportLists]><span style="font-size:11.0pt"><span style="mso-list:Ignore">5.<span style="font:7.0pt "Times New Roman"">
</span></span></span><![endif]><b><span style="font-size:11.0pt">DS TSI</span></b><span style="font-size:11.0pt"> - updated to reflect current exclusion criteria and the addition of the LEAP measures to the screening call.<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:0in;margin-right:0in;margin-bottom:5.0pt;margin-left:78.0pt;text-indent:-.25in;mso-list:l0 level1 lfo1">
<![if !supportLists]><span style="font-size:11.0pt"><span style="mso-list:Ignore">6.<span style="font:7.0pt "Times New Roman"">
</span></span></span><![endif]><b><span style="font-size:11.0pt">FU TSI DS Infant and control</span></b><span style="font-size:11.0pt"> - updated to reflect current exclusion criteria<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:0in;margin-right:0in;margin-bottom:5.0pt;margin-left:78.0pt;text-indent:-.25in;mso-list:l0 level1 lfo1">
<![if !supportLists]><span style="font-size:11.0pt"><span style="mso-list:Ignore">7.<span style="font:7.0pt "Times New Roman"">
</span></span></span><![endif]><span style="font-size:11.0pt">The WU PI has officially been changed to Natasha Marrus so all documents moving forward will list her as the PI<o:p></o:p></span></p>
<ol style="margin-top:0in" start="8" type="1">
<li class="MsoNormal" style="margin-bottom:5.0pt;margin-left:42.0pt;mso-list:l0 level1 lfo1">
<span style="font-size:11.0pt">Local approval doc <o:p></o:p></span></li></ol>
<p class="MsoNormal" style="mso-margin-top-alt:0in;margin-right:0in;margin-bottom:5.0pt;margin-left:78.0pt;text-indent:-.25in;mso-list:l0 level1 lfo1">
<![if !supportLists]><span style="font-size:11.0pt"><span style="mso-list:Ignore">9.<span style="font:7.0pt "Times New Roman"">
</span></span></span><![endif]><span style="font-size:11.0pt">WU partial and full HIPAA waivers are attached.<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:0in;margin-right:0in;margin-bottom:5.0pt;margin-left:78.0pt;text-indent:-.25in;mso-list:l0 level1 lfo1">
<![if !supportLists]><span style="font-size:11.0pt"><span style="mso-list:Ignore">10.<span style="font:7.0pt "Times New Roman"">
</span></span></span><![endif]><b><span style="font-size:11.0pt">NEW intervention history is now approved.</span></b><span style="font-size:11.0pt"> This should be used with Infant DS subjects in place of the BSRC form. We will also be switching to this form
for EP, but that still needs to be IRB approved. Start using this form for Infant DS immediately.<o:p></o:p></span></p>
<p class="MsoNormal" style="mso-margin-top-alt:0in;margin-right:0in;margin-bottom:5.0pt;margin-left:78.0pt;text-indent:-.25in;mso-list:l0 level1 lfo1">
<![if !supportLists]><span style="font-size:11.0pt"><span style="mso-list:Ignore">11.<span style="font:7.0pt "Times New Roman"">
</span></span></span><![endif]><span style="font-size:11.0pt">Protocol has been updated and uploaded to LORIS<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:5.0pt"><span style="font-size:11.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal" style="margin-bottom:5.0pt"><span style="font-size:11.0pt">IBIS Executive Committee<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:5.0pt"><span style="font-size:11.0pt"> New Project approved: Early white matter microstructure development in infants with Down Syndrome, first look<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:5.0pt"><span style="font-size:11.0pt"> Investigators: Martin Styner, Omar Azrak, Dea Garic, Mark Shen, Aleeshah Nasir.
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt"><o:p> </o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt">IBIS SA/ADOL<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt"> Sa Enrichment cohort was expanded to include HL- subjects<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt"> Timepoint label in LORSI will be: V-ADOL<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt">
<o:p></o:p></span></p>
</blockquote>
<p style="margin:0in"><span style="font-size:12.0pt"> IBIS EP Proband Med Records<o:p></o:p></span></p>
<p style="margin:0in"> Decision/clarification: <o:p>
</o:p></p>
<p style="margin:0in"> We will not collect medical records from probands other than their <b>cognitive/IQ score</b>.<o:p></o:p></p>
<p style="margin:0in"> Supporting documents for this effort has been sent to the IBIS Coordinators.<o:p></o:p></p>
<p style="margin:0in"> Will be discussed on next Coordinator call.<o:p></o:p></p>
<p style="margin:0in"> <o:p></o:p></p>
<p style="margin:0in"> <o:p></o:p></p>
<p style="margin:0in"><span style="font-size:12.0pt">Have a wonderful weekend everyone!!!</span><o:p></o:p></p>
<p style="margin:0in;font-stretch: normal;font-size-adjust: none;font-kerning: auto;font-variant-alternates: normal;font-variant-ligatures: normal;font-variant-numeric: normal;font-variant-east-asian: normal;font-variant-position: normal;font-feature-settings: normal;font-optical-sizing: auto;font-variation-settings: normal">
<span style="font-size:12.0pt;color:black"> </span><o:p></o:p></p>
<p style="margin:0in;font-stretch: normal;font-size-adjust: none;font-kerning: auto;font-variant-alternates: normal;font-variant-ligatures: normal;font-variant-numeric: normal;font-variant-east-asian: normal;font-variant-position: normal;font-feature-settings: normal;font-optical-sizing: auto;font-variation-settings: normal">
<span style="font-size:12.0pt;color:#1D1D1D"> Chad</span><o:p></o:p></p>
<p style="margin:0in;font-stretch: normal;font-size-adjust: none;font-kerning: auto;font-variant-alternates: normal;font-variant-ligatures: normal;font-variant-numeric: normal;font-variant-east-asian: normal;font-variant-position: normal;font-feature-settings: normal;font-optical-sizing: auto;font-variation-settings: normal">
<span style="color:black"> </span><o:p></o:p></p>
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