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class="last leaf menu-mlid-3926"><a href="/guidance">Guidance A to Z</a></li> </ul></li> </ul></div> </div> </div> </div> </div> </div> <div id="breadcrumb" class="row-full-width"><div class="inside"><h2 class="element-invisible">You are here</h2><div class="breadcrumb"><a href="/">Home</a> > <a href="/our-services">Our Services</a> > <span class="breadcrumb-page-title">Post-Approval Reporting/Quality Improvement</span></div></div></div> <h1 class="title" id="page-title">Reporting/Monitoring/Quality Improvement Unit</h1> <div class="content-top"> </div> <div id="main-wrapper"> <div id="main" class="clearfix"> <div id="content" class="column"> <div 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-426" class="node node-page slider-secondary clearfix" about="/reporting" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="Reporting/Monitoring/Quality Improvement Unit" 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-body field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even"><p>The Quality Improvement Unit (QIU) unit of the HRPP conducts post-approval monitoring, education/training and other quality improvement activities. The primary role of the QIU is to monitor the conduct of clinical research to assure the rights and welfare of human research participants and to optimize adherence to federal regulations, state laws, institutional policies and research protocols approved by the UCSF IRB.</p> <h3>QIU Activities:</h3> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a id="site" name="site"></a><a class="accordion">On-site review of clinical research (Currently Unavailable)</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>Given the large number of studies at UCSF, it is not possible for the QIU to review each study. QIU on-site review activities will focus primarily on studies that do not undergo some degree of formal routine on-site monitoring. The QIU selects studies for review or investigation based on either “Routine” or “Directed” criteria<strong>.</strong></p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="accordion">Post-approval QA activities</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>The QIU processes and manages all <a href="/adverse-event">adverse events</a>, <a href="http://hrpp.ucsf.edu/protocol-violation-or-incident">protocol violations and incident reports</a> submitted to the IRB.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="accordion">Research participant complaints</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>The QIU manages and investigates (as appropriate) all serious, non-routine <a href="/responding-and-reporting-research-related-concerns-and-complaints">research participant complaints</a>. Examples include complaints of study-related injury, safety concerns, violations of participants’ rights, problems related to past research participation, etc.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="accordion">Indirect monitoring of clinical research</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>The QIU compiles and assesses existing monitoring and reporting data that have been generated via Data Monitoring Committee or DSMB reports, or cooperative/collaborative audits (i.e., NCI, CALBG, VAMC, etc.) The QIU also monitors publications of UCSF investigators to ensure that proper IRB approvals were in place for these studies.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="accordion">On-site assessment and training for researchers</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>The QIU conducts on-site assessment and training when requested by a UCSF-affiliated research team member or the IRB.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a id="ongoing" name="ongoing"></a><a class="accordion">Internal QA and QI activities</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>The QIU conducts periodic, routine QA audits of the IRB/HRPP to assess compliance with federal, state and UCSF policies, identify areas for improvement, and to suggest remedies based on existing policies/procedures and current or projected staffing levels. </p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="accordion" href="#">Informing the IRB of findings</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>Based on findings from on-site routine reviews and directed investigation activities, the QIU provides the IRB with:</p> <ul> <li>Documentation, analyses and reporting of investigatory findings</li> <li>Recommendations and corrective action plans</li> <li>Construction and/or revision of HRPP guidance</li> <li>Development and tailoring of educational materials and training program</li> </ul> </div> </div> <p> </p> <h3>Reporting:</h3> <ul> <li><a href="https://irb.ucsf.edu/adverse-event-or-safety-information" target="_blank">Adverse Events</a>, <a href="https://irb.ucsf.edu/protocol-violation-or-incident" target="_self">Protocol Violations or Incidents</a> and <a href="https://irb.ucsf.edu/adverse-event" target="_self">other types of Safety Information</a> that meet reporting criteria</li> <li>Final Clinical Reports <ul> <li>There is no requirement to submit <i>final clinical study report(s) to the IRB, </i>no matter the stage of the study.</li> </ul> </li> </ul> <p> </p> <p> </p> <p> </p> <p> </p> <p> </p> <p> </p> <p> </p> <div class="accordian-content"> <p> </p> <ul> </ul> </div> </div></div></div> </div> </div> </div> </div> <div id="block-views-last-updated-block" class="block block-views"> <div class="content"> <div class="view view-last-updated view-id-last_updated view-display-id-block view-dom-id-50a4df044a9064ba26db2435308139de"> <div class="view-content"> <div> <p class="updated-date"> <span>Last updated: </span> September 27, 2023 </p> </div> </div> </div> </div> </div> </div> </div> </div> <div id="sidebar" class="column"> <div class="sidebar_top"> <div class="region region-sidebar-top"> <div id="block-menu-block-2" class="block block-menu-block"> <h3><a href="/reporting" class="active-trail active">Post-Approval Reporting/Quality Improvement</a></h3> <div class="content"> <div class="menu-block-wrapper menu-block-2 menu-name-main-menu parent-mlid-0 menu-level-2"> <ul class="menu"><li class="first leaf menu-mlid-3791"><a href="/adverse-event">Adverse Event</a></li> <li class="leaf menu-mlid-3796"><a href="/monitoring">Monitoring</a></li> <li class="leaf menu-mlid-4036"><a href="https://irb.ucsf.edu/sites/g/files/tkssra6501/f/post-approval-reporting-summary-sheet.pdf" title="">Post Approval Reporting Requirements Summary Sheet</a></li> <li class="leaf menu-mlid-3806"><a href="/protocol-violation-or-incident">Protocol Violation or Incident</a></li> <li class="leaf menu-mlid-4076"><a href="/reporting-research-concerns-and-complaints">Reporting Research Concerns and Complaints</a></li> <li class="leaf menu-mlid-3816"><a href="/research-tools-and-checklists">Research Tools and Checklists</a></li> <li class="last leaf menu-mlid-3821"><a href="/responding-and-reporting-research-related-concerns-and-complaints">Responding to Complaints</a></li> </ul></div> </div> </div> </div> </div> <div class="sidebar"> <div class="section"> <div class="region region-sidebar"> <div id="block-block-16" class="block block-block"> <h3>Quicklinks </h3> <div class="content"> <p><a class="btn--large btn--more--reverse btn--full-width" href="https://ucsf.co1.qualtrics.com/jfe/form/SV_06qk41JwVXpOdMx"><font color="yellow">Questions? </font><font color="lightseagreen">Ask Andy</font> (<font color="lightseagreen">An</font>alyst of the <font color="lightseagreen">D</font>a<font color="lightseagreen">y</font>)</a></p> <p> </p> <p><a class="btn--large btn--more--reverse btn--full-width" href="https://iris.ucsf.edu/">Log into iRIS ↗️</a> </p> <p><a class="btn--large btn--more--reverse btn--full-width" href="https://iris-help.ucsf.edu/irb-iris">iRIS Help site</a></p> <p> </p> <p><a class="btn--large btn--more--reverse btn--full-width" href="/submissions">Submissions</a></p> <p> </p> <p><a class="btn--large btn--more--reverse btn--full-width" href="/sites/g/files/tkssra6501/f/where%20is%20my%20study_0.pdf"> check your study status</a></p> <p> </p> <p><a class="btn--large btn--more--reverse 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