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class="inside"> <a id="main-content"></a> <div class="tabs"></div> <div class="region region-content"> <div id="block-system-main" class="block block-system"> <div class="content"> <div id="node-1181" class="node node-page slider-secondary clearfix" about="/virtual-regulatory-binder" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="Virtual Regulatory Binder" class="rdf-meta element-hidden"></span><span property="sioc:num_replies" content="0" datatype="xsd:integer" class="rdf-meta element-hidden"></span> <div class="content"> <div class="field field-name-field-last-revised field-type-datetime field-label-inline inline"><div class="field-label">Last revised<span class="colon">:</span> </div><div class="field-items"><div class="field-item even"><span property="dc:date" datatype="xsd:dateTime" content="2017-08-28T00:00:00-07:00" class="date-display-single">08/28/2017</span></div></div></div><div class="field field-name-field-body field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even"><h2>Introduction</h2> <p><strong>Congratulations!</strong> You have successfully accessed the UCSF Human Research Quality Improvement Unit (QIU) <em>Virtual Regulatory Binder</em>. We thank Partners Healthcare for providing this invaluable resource so it could be modified for use at UCSF. This binder is applicable for behaviorial, FDA, and non-FDA regulatory compliance.</p> <p><strong>Purposes of the Binder</strong></p> <p>The QIU Virtual Regulatory Binder assists sites in achieving and maintaining regulatory compliance and ensuring the highest standards of human subject research. The binder also provides:</p> <ol> <li> <p>Guidance for organization and record keeping.</p> </li> <li> <p>Assistance with proper study documentation and successful study management, including guidance on electronically stored records. </p> </li> <li> <p>Links to on-line resources, such as the UCSF Institutional Review Board (IRB) policies, guidelines, and forms, the Clinical Research Resource <strong><em>HUB</em></strong>, institutional policies, good clinical practices, and Federal Regulations.</p> </li> </ol> <p> </p> </div></div></div> </div> </div> </div> </div> </div> </div> </div> <div id="sidebar" class="column"> <div class="sidebar"> <div class="section"> <div class="region region-sidebar"> <div id="block-menu-block-3" class="block block-menu-block"> <h3><a href="/virtual-regulatory-binder" title="removed whom to contact as the QIU no longer provides consultations on the virtual binder." class="active-trail active">Regulatory Binder</a></h3> <div class="content"> <div class="menu-block-wrapper menu-block-3 menu-name-main-menu parent-mlid-0 menu-level-3"> <ul class="menu"><li class="first leaf menu-mlid-2451"><a href="/regulatory-binder-instructions">Instruction Manual</a></li> <li class="leaf menu-mlid-2356"><a href="/virtual-regulatory-binder-consent-forms">Consent Forms</a></li> <li class="leaf menu-mlid-2171"><a href="/virtual-regulatory-binder-cvs">CV's</a></li> <li class="leaf menu-mlid-2186"><a href="/virtual-regulatory-binder-data-collection">Data Collection</a></li> <li class="leaf menu-mlid-2271"><a href="/virtual-regulatory-binder-dsmb">DSMB</a></li> <li class="leaf menu-mlid-2471"><a href="/virtual-regulatory-binder-drug-device-accountability">Drug / Device Accountability</a></li> <li class="leaf menu-mlid-2261"><a href="/virtual-regulatory-binder-fda">FDA</a></li> <li class="leaf menu-mlid-2296"><a href="/virtual-regulatory-binder-financial-disclosure">Financial Disclosure</a></li> <li class="leaf menu-mlid-2246"><a href="/virtual-regulatory-binder-irb-hrc">IRB</a></li> <li class="leaf menu-mlid-2196"><a href="/virtual-regulatory-binder-licensure">Licensure</a></li> <li class="leaf menu-mlid-2416"><a href="/virtual-regulatory-binder-logs">Logs</a></li> <li class="leaf menu-mlid-2461"><a href="/virtual-regulatory-binder-lab-documents">Lab Documents</a></li> <li class="leaf menu-mlid-2311"><a href="/virtual-regulatory-binder-protocols">Protocols</a></li> <li class="last leaf menu-mlid-2336"><a href="/virtual-regulatory-binder-sponsor">Sponsor</a></li> </ul></div> </div> </div> </div> </div> </div> </div> </div></div> <div id="footer"> <div class="section"> <div class="region region-footer"> <div id="block-block-6" class="block block-block"> <div class="content"> <style type="text/css"> <![CDATA[/* ><!]]>*/ </style> <div class="quickref"> <h2 style="color:#000;font-size:22px;margin:0;padding: 0 0 6px;">Quick Reference</h2> <div class="wysiwyg_threecols layout--33-33-33"> <div class="wysiwyg_threecols--first"> <ul> <li><a href="http://policies.ucsf.edu/" target="_blank">Campus Policies</a></li> <li><a href="http://cancer.ucsf.edu/" target="_blank">Cancer Center (HDFCCC)</a></li> <li><a href="http://accelerate.ucsf.edu/research/crs" target="_blank">Clinical Research Services</a></li> <li><a href="http://ctsi.ucsf.edu" target="_blank">Clinical & Translational Science Institute (CTSI)</a></li> </ul> </div> <div class="wysiwyg_threecols--second"> <ul> <li><a href="http://coi.ucsf.edu/" target="_blank">Conflicts of Interest (COI)</a></li> <li><a href="http://accelerate.ucsf.edu/consult" target="_blank">Consultation Services</a></li> <li><a href="http://accelerate.ucsf.edu/cores/" target="_blank">Cores Search</a></li> <li><a href="https://ehs.ucsf.edu/" target="_blank">Environment, Health and Safety</a></li> <li><a href="http://compliance.ucsf.edu/" target="_blank">Ethics & Compliance</a></li> </ul> </div> <div class="wysiwyg_threecols--third"> <ul> <li><a href="http://globalhealthsciences.ucsf.edu/" target="_blank">Global Health Sciences</a></li> <li><a href="http://ita.ucsf.edu/" target="_blank">Innovation, Technology & Alliances</a></li> <li><a href="http://irb.ucsf.edu" target="_blank">IRB / Human Research Protection Program</a></li> <li><a href="https://osr.ucsf.edu/" target="_blank">Office of Sponsored Research</a></li> <li><a href="http://profiles.ucsf.edu" target="_blank">UCSF Profiles</a></li> </ul> </div> </div> </div> <p style="float: right; 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