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class="tabs"></div> <div class="region region-content"> <div id="block-system-main" class="block block-system"> <div class="content"> <div id="node-1346" class="node node-page slider-secondary clearfix" about="/data-safety-monitoring" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="Data Safety Monitoring" 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="2017-10-09T00:00:00-07:00" class="date-display-single">10/09/2017</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"><p>The NIH requires data and safety monitoring for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III); etc.</p> <p>Monitoring should be commensurate with risks -- The method and degree of monitoring needed is related to the degree of risk involved. A monitoring committee is usually required to determine safe and effective conduct and to recommend conclusion of the trial when significant benefits or risks have developed or the trial is unlikely to be concluded successfully.</p> <p><strong>Data Safety Monitoring Plans</strong><br /> A <a href="https://irb.ucsf.edu/data-and-safety-monitoring-plans-and-boards">Data and Safety Monitoring <em>Plan</em> (DSMP)</a> is just one of the mechanisms used to ensure the safety of study subjects as well as maintain data validity, integrity, and scientific merit. UCSF policy <strong>requires that </strong><strong>all interventional studies</strong> involving more than minimal risk must include a <strong>DSMP</strong>. <strong>DSMPs</strong> depend upon many variables, such as the degree of risk, disease being studied, subject population, and number of sites where the research is being conducted. Complex <strong>DSMPs</strong> frequently include a <strong>Data Safety Monitoring Board (DSMB)</strong>. The DSMP should indicate specifically whether or not there will be a formal Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC).<br /> <br /> <strong>UCSF DSM Protocol Examples</strong><br /> <a href="/dsm-examples">Examples contributed by UCSF faculty</a><a href="https://accelerate.ucsf.edu/research/dsmb"> </a>provide language to assist researchers in preparing protocols with Data Safety Monitoring Plans (DSMP) and Boards (DSMB), including large scale, multicenter trials, and more. </p> <p>Need assistance or have clinical study management questions? <a href="https://accelerate.ucsf.edu/consult/design">Request a CTSI Study Design & Implementation Consultation</a></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="/data-safety-monitoring" class="active-trail active">Data Safety Monitoring</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-2381"><a href="/dsmb">Data Safety Monitoring Board (DSMB)</a></li> <li class="leaf menu-mlid-4291"><a href="/dsm-examples">UCSF DSM Examples & Checklist</a></li> <li class="last leaf menu-mlid-2446"><a href="/dsmp-tools">NIH Guidance, Tools & Templates</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; margin: 1.2em 30px -1.5em; text-align: right; width: 6em;"><a href="/cdn-cgi/l/email-protection#723a273032071101145c171607" style="color:#FFF"><span class="__cf_email__" data-cfemail="7c34293e3c091f0f1a52191809">[email protected]</span></a></p> </div> </div> </div> <div class="footer-bottom"> <nav aria-label="Footer Navigation" class="footer--navigation"> <ul> <li><a href="/cdn-cgi/l/email-protection#efa7baadaf9a8c9c89c18a8b9a">Contact Us</a></li> <li><a href="https://www.ucsf.edu/accessibility-resources">Accessibility</a></li> <li><a href="https://www.ucsf.edu/website-privacy-policy">Privacy Policy</a></li> <li><a href="https://websites.ucsf.edu/website-terms-use">Terms of Use </a></li> <li><a href="https://websites.ucsf.edu/azlist">A-Z Website List</a></li> </ul> </nav> <div class="footer--copyright"> <p>© 2024 The Regents of the University of California</p> </div> </div> </div> </div> </div> </div> <script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script><script type="text/javascript"> /*<![CDATA[*/ (function() { var sz = document.createElement('script'); sz.type = 'text/javascript'; sz.async = true; sz.src = '//siteimproveanalytics.com/js/siteanalyze_8343.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(sz, s); })(); /*]]>*/ </script> </body> </html>