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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="/recruitment-consent-and-hipaa">Recruitment, Consent, HIPAA</a> > <span class="breadcrumb-page-title">FDA Part 11 Compliance Assurances</span></div></div></div> <h1 class="title" id="page-title">FDA Part 11 Compliance Assurances</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-9631" class="node node-page slider-secondary clearfix" about="/fda-part-11-compliance-assurances" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="FDA Part 11 Compliance Assurances" 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"><h3>FDA Part 11 Compliance Assurances</h3> <p>UCSF has a version of DocuSign and REDCap Premium that are compliant with the FDA’s regulation at 21 CFR Part 11 for electronic signatures (commonly referred to as “Part 11”). If you are conducting an FDA-regulated study and you are utilizing either of these electronic platforms to collect research signatures, the study sponsor may ask for assurances that the platforms are Part 11 compliant. The documents on this page can be provided to study sponsors when such requests are made.</p> <p>Note: For information about how to determine whether you need an FDA compliant signature platform, how to decide which platform is the best fit for your study, and where to access more information about the platforms, please see <strong>FAQ #2 (“How can I obtain signed consent electronically?”)</strong> on the <a href="https://irb.ucsf.edu/irb-covid-19-faqs-resources">IRB COVID-19 FAQ & Resources</a> page.</p> <h3>UCSF Electronic Signature Certificate/Non-Repudiation Statement and Letter</h3> <p>This statement and letter from UCSF Senior Associate Vice Chancellor - Research, Brian Smith, JD, MBA may be provided to sponsors if requested: </p> <ul> <li><a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/part%2011%20compliance%20statement.pdf">Statement on University of California, San Francisco Compliance with 21 CFR Part 11 and (5/20/21)</a>. Note: This also includes a statement on Non-Repudiation of Electronic Signatures in the DocuSign Part 11 Module and the REDCap Premium Software Platform (5/18/21).</li> <li><a href="/sites/g/files/tkssra6501/f/Signed%20UCSF%20non-repudiation%20letter%20for%20ESG%20accounts.pdf">Signed UCSF non-repudiation letter re: Electronic Signature Certificate Statement (5/18/21)</a></li> </ul> <h3>HRPP Memos</h3> <p>Memos may be shared with research sponsors to document the UCSF Human Research Protection Program’s guidance on obtaining electronic consent and HIPAA authorization signatures during the COVID-19 public health emergency.</p> <p>Current memo: <a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/hrpp%20Sponsor%20Memo_%20April%202021%20Update%20on%20eConsent.pdf">April 2021 Update on Electronic Consent Signatures Memo</a></p> <p>Earlier memos are available for reference as needed: <a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/hrpp%20Sponsor%20Memo_eConsent%20Signatures_%2028MAY20.pdf">5/28/2020 Memo</a> and <a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/hrpp%20Sponsor%20Memo_%20Sep%20Update%20on%20eConsent.pdf">9/29/2020 Memo</a></p> </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-d8915d65c76f32e11e5be244803caf44"> <div class="view-content"> <div> <p class="updated-date"> <span>Last updated: </span> November 8, 2023 </p> </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-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 btn--full-width" href="/participating-research">Participating in UCSF Research</a></p> <p> </p> <p><a class="btn--large btn--blue btn--full-width" href="https://ucsf.co1.qualtrics.com/jfe/form/SV_3z3mGySSIA907k1?Q_JFE=qdg">iRb SATISFACTION SURVEY</a></p> </div> </div> <div id="block-block-26" class="block block-block"> <h3>Top Resources </h3> <div class="content"> <ul> <li><a href="/quick-guide-activities-requiring-irb-review" target="_blank">Activities Requiring IRB Review</a></li> <li><a href="/news">Bulletins</a></li> <li><a href="https://cancer.ucsf.edu/clinical-research/conducting-cancer-research">Cancer Research Activation Workflow</a></li> <li><a href="/citi-human-subjects-training">CITI Human Subjects Training </a></li> <li><a href="/consent-and-assent-form-templates">Consent Form Templates</a></li> <li><a href="/contact-us">Contact Us</a></li> <li><a href="/irb-covid-19-faqs-resources">COVID-19 FAQ's</a> </li> <li><a href="/guidance">Guidance A to Z</a></li> <li><a href="/hipaa">HIPAA Authorization Form </a></li> <li><a href="/irb-rosters-meeting-dates">IRB Rosters & Meeting Dates</a></li> <li><a href="/hrpp-job-opportunities">Job Opportunities</a></li> <li><a href="/participating-research">Participating in Research</a> </li> <li><a href="/sites/g/files/tkssra6501/f/post-approval-reporting-summary-sheet.pdf">Post-Approval Reporting Requirements</a></li> <li><a href="/reporting-research-concerns-and-complaints">Reporting Research Complaints</a></li> <li><a href="/submissions">Submit to the IRB</a></li> <li><a href="/when-ucsf-can-serve-irb-record" target="_blank">UCSF IRB of Record</a></li> <li><a href="/working-other-institutions">Working with Other Institutions</a></li> </ul> </div> </div> </div> </div> </div> </div> </div></div> <div id="footer"> <div class="section"> <div class="region region-footer"> <div id="block-block-21" class="block block-block"> <div class="content"> <div class="wysiwyg_twocols layout--50-50"> <div class="wysiwyg_twocols--first bg--transparent"> <p>Human Research Protection Program<br /> 490 Illinois Street, Floor 6<br /> San Francisco, CA 94143<br /> Phone: (415) 476-1814</p> <p>Fax: (415) 353-4418<br /> Email: <a href="/cdn-cgi/l/email-protection#58110a1a182d3b2b3e763d3c2d"><span class="__cf_email__" data-cfemail="abe2f9e9ebdec8d8cd85cecfde">[email protected]</span></a> </p> </div> <div class="wysiwyg_twocols--second bg--transparent"> <p style="text-align: right;"><a class="btn--small btn--more--white" href="https://ucsf.co1.qualtrics.com/jfe/form/SV_8k8x8jRnFhOJ6Xr">Website Feedback </a></p> </div> </div> <p> </p> </div> </div> </div> <div class="footer-bottom"> <nav aria-label="Footer Navigation" class="footer--navigation"> <ul> <li><a href="/contact-us">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>