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Education & Training | Human Research Protection Program (HRPP)

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property="dc:title" content="Education &amp; Training" 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"><ul> <li><a href="#educationopportunities">Education Opportunities</a></li> <li><a href="#citi">CITI Training</a></li> <li><a href="#in-service">In-Service Education Training</a></li> <li><a href="#toolsandchecklists">IRB Research Tools and Checklists</a></li> <li><a href="#pastclasses">Past Classes and Slides</a></li> <li><a href="#otherresources">Other Education Resources</a></li> </ul> <h2><a id="educationopportunities" name="educationopportunities"></a>Education Opportunities</h2> <p>Explore our <a href="/education-opportunities">Education Opportunities</a> page for information on upcoming classes and access to materials from previous sessions.</p> <h2><a id="citi" name="citi"></a>CITI Training</h2> <p class="bodyTextMedium">All <a href="/citi-human-subjects-training">Key Personnel</a> at UCSF or affiliated sites involved in Human Subjects Research are required to complete CITI training in human subjects protection (HSP). This requirement applies to Key Study Personnel on Exempt, Expedited, and Full Board studies. To check your CITI training status and for <a href="/citi-human-subjects-training">detailed instructions on completing or updating your training</a>, please refer to the following lists:</p> <div class="wysiwyg_twocols layout--50-50"> <div class="wysiwyg_twocols--first bg--interactive-dark-blue"> <p><strong><font color="sky blue">Human Subjects Protection (HSP)</font></strong></p> <ul> <li><a href="/sites/g/files/tkssra6501/f/ucsf%20citi%20training%20list.pdf" target="_blank">UCSF completion list</a></li> <li><a href="/sites/g/files/tkssra6501/f/va%20citi%20training%20list_0.pdf">SFVAHCS completion list</a></li> </ul> <p> </p> </div> <div class="wysiwyg_twocols--second bg--interactive-dark-blue"> <p><strong><font color="sky blue">Good Clinical Practice (GCP)</font></strong></p> <ul> <li><font color="sky blue"><a href="/sites/g/files/tkssra6501/f/ucsfgcp%20training%20list.pdf">UCSF completion list</a></font></li> </ul> </div> </div> <h2><a id="in-service" name="in-service"></a>In-service Education Training</h2> <p>Need a department-specific training session? In-Service education ensures that everyone receives consistent information on key topics. To request a session, please complete the <a href="http://ucsf.co1.qualtrics.com/jfe/form/SV_73g8ftcFukhinqt"><strong>Request for In-Service Training form</strong></a>.</p> <h2><a id="toolsandchecklists" name="toolsandchecklists"></a>IRB Research Tools and Checklists</h2> <p>These tools and checklists are designed to support compliance and streamline study processes:</p> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Submission and Reporting:</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <ul> <li><a href="/sites/g/files/tkssra6501/f/initial-submission-checklist%202023.pdf">Initial Submission Checklist</a> <em>(Last updated Oct 2023)</em></li> <li><a href="/sites/g/files/tkssra6501/f/post-approval-reporting-summary-sheet.pdf">Post Approval Reporting Requirements</a> <em>(Last updated Mar 2024)</em></li> </ul> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Consent:</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <ul> <li><a href="https://irb.ucsf.edu/sites/g/files/tkssra6501/f/wysiwyg/checklist%20non%20ucsf%20checklist.pdf">Consent Form Checklist for Using a Non-UCSF Consent Form</a> <em>(Last updated Apr 2024)</em></li> <li><a href="http://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/gds-checklist.pdf">NIH GDS Policy Consent Checklist</a> <em>(Last updated Jul 2015)</em></li> </ul> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Study-Specific Documents:</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <ul> <li><a href="https://irb.ucsf.edu/sites/g/files/tkssra6501/f/device-checklist.pdf">UCSF Investigator Checklist for IDE Exempt, Non-Significant, and Significant Risk Device Studies</a> <em>(Last Updated Oct 2018)</em></li> <li><a href="/sites/g/files/tkssra6501/f/Routine%20Site%20Visit%20Report.pdf">UCSF Routine On-Site Review Form</a></li> </ul> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Quality and Compliance Documentation:</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <ul> <li><a href="http://hub.ucsf.edu/quality-management-practices">Quality Management Plans</a></li> <li><a href="https://hub.ucsf.edu/virtual-regulatory-binder">Regulatory Binder Requirements</a></li> <li><a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/delegation-of-authority-documentation-log.doc">Delegation of Authority Documentation Log</a></li> <li><a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/investigational-agent-accountability-record.doc">Drug or Biologic Dispensing / Accountability Log</a></li> <li><a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/screening-enrollment-withdrawal-log.doc">Screening / Enrollment / Withdrawal Log</a></li> <li><a href="https://irb.ucsf.edu/sites/g/files/tkssra6501/f/UCSF%20CAPA%20Training_log.doc">UCSF Corrective and Preventative Action (CAPA) Training Log</a></li> <li><a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/investigational-device-accountability-log.doc">Device Dispensing / Accountability Log</a> <ul> <li>Example: <a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/example-study-events-tracking-form.doc">Study Events Tracking Form</a></li> <li>Example: <a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/example-tracking-system-for-deadlines-reporting.xls">Tracking System for Deadlines and Reporting</a></li> </ul> </li> <li>FDA and OHRP Inspections: Please notify UCSF upon receiving the call or letter to schedule the inspection. See the <a data-once="isExternalLink" href="http://hub.ucsf.edu/fda-and-ohrp-inspections" tabindex="-1" target="_blank">UCSF Clinical Research HUB</a> for more information about whom to contact and how to prepare for the inspection.</li> </ul> </div> </div> <p> </p> <h2 class="bodyTextMedium"><a id="pastclasses" name="pastclasses"></a>Past Classes and Slides</h2> <ul> <li><a href="http://hrpp.ucsf.edu/sites/hrpp.ucsf.edu/files/routine-site-visit-class.pdf" target="_blank">Findings From Routine Site Visits Conducted by the Quality Improvement Unit (QIU)</a></li> <li><a href="http://hrpp.ucsf.edu/sites/hrpp.ucsf.edu/files/post-approval-event-class.pdf" target="_blank">Post-Approval Event Reporting</a> and <a href="http://hrpp.ucsf.edu/sites/hrpp.ucsf.edu/files/subject-injury-program-class.pdf" target="_blank">Overview of UCSF's Subject Injury Program</a></li> <li><a href="http://hrpp.ucsf.edu/sites/hrpp.ucsf.edu/files/consent-class.pdf" target="_blank">Preparing Consent and Assent Forms and the Consent Process</a></li> <li><a href="http://hrpp.ucsf.edu/sites/hrpp.ucsf.edu/files/recruitment-class.pdf" target="_blank">Recruitment: Ethics, Regulations and Practical Solutions</a> and <a href="http://www.slideshare.net/CTSIatUCSF/chr-workshop-may20121">Technology and Best Practices for Recruitment</a></li> <li><a href="http://hrpp.ucsf.edu/sites/hrpp.ucsf.edu/files/modification-continuing-review-class.pdf" target="_blank">Submitting Modifications and Continuing Reviews</a></li> </ul> <p>Currently Unavailable: </p> <ul> <li>IRB Introductory Training Archived Webinar/Slides</li> <li>Preparing a New IRB Application</li> </ul> <p>Note: The IRB was formerly known as the Committee on Human Research (CHR), which is the term used in some of these presentations.</p> <h2><a id="otherresources" name="otherresources"></a>Other Education Resources</h2> <p><strong>UCSF</strong></p> <ul> <li><a href="http://hub.ucsf.edu//sites/hub.ucsf.edu/files/cr-training.pdf" target="_blank">Suggested Training for Clinical Research</a>: The UCSF Clinical Research Training document provides essential and supplementary training resources for Clinical Research Coordinators (CRCs), covering areas like HIPAA, informed consent, Good Clinical Practice, and data security. Each training component includes links, requirements, and estimated completion times.</li> <li><a href="https://ctsi.ucsf.edu/programs/clinical-trials-operations">Clinical Trials Operations (CTO)</a>:The Clinical Trials Operations (CTO)<strong> </strong>Unit serves as an institutional representative and advocate for the UCSF clinical trials community. The CTO aims to identify, assess and prioritize barriers for inclusive and efficient trials, and steward solutions to challenges that adversely impact clinical trials operations. <a href="https://ctsi.ucsf.edu/programs/clinical-trials-operations/events">View upcoming and past events. </a></li> <li><a href="https://rcr.ucsf.edu/">Responsible Conduct of Research</a>: A guide for RCR training for UCSF learners and researchers at all levels — graduate students, postdocs, and faculty — and a resource for NIH training grant faculty and administrators. </li> <li><a href="https://hub.ucsf.edu/training">UCSF Clinical Research Resource HUB: Training</a></li> <li><a href="http://ctsi.ucsf.edu/">Clinical and Translational Science Institute</a> (CTSI) </li> </ul> <p><strong>Other Groups or Institutions</strong></p> <ul> <li><a href="http://www.centerwatch.com/" target="_blank">Center Watch Resources</a></li> <li><a href="http://cbssm.med.umich.edu/how-we-can-help/tools-and-resources/informed-consent" target="_blank">University of Michigan Online Course: Valid Consent/Refusal to Participate in Research</a></li> </ul> <p><strong>Federal Government</strong></p> <ul> <li><a href="http://www.hhs.gov/ohrp/education-and-outreach/upcoming-educational-events/index.html" target="_blank">Office of Human Research Protections (OHRP): Education Resources (Includes In-Person Events and Online Educational Opportunities)</a></li> <li><a href="http://www.nih.gov/health/clinicaltrials/resources.htm" target="_blank">NIH: Educational Materials About Clinical Trials</a></li> </ul> <p><strong>National Conferences and Workshops</strong></p> <ul> <li><a href="http://www.socra.org/html/SoCRA_Ed_Calendar.htm" target="_blank">Society of Clinical Research Associates (SoCRA) Educational Opportunities Calendar</a></li> <li><a href="http://www.primr.org/" target="_blank">Public Responsibility in Medicine and Research (PRIM&amp;R) Conferences</a></li> </ul> <p class="bodyTextMedium"><font color="sky blue"><font color="teal"> </font></font></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-650e0d1c232cafb743c2e771ec0b97e5"> <div class="view-content"> <div> <p class="updated-date"> <span>Last updated: </span> December 2, 2024 </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="/training" class="active-trail active">Education &amp; Training</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-3996"><a href="/citi-human-subjects-training">CITI Training</a></li> <li class="leaf menu-mlid-3846"><a href="/clinical-research-coordinators-council">CRC Council</a></li> <li class="leaf menu-mlid-3851"><a href="/education-opportunities">Education Opportunities</a></li> <li class="last leaf menu-mlid-3856"><a href="/responsibilities-pis-and-crcs">Roles and Responsibilities of PIs and CRCs</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 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 &amp; 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#b1f8e3f3f1c4d2c2d79fd4d5c4"><span class="__cf_email__" data-cfemail="e0a9b2a2a095839386ce858495">[email&#160;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>&copy; 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>

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