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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">Education & Training</span></div></div></div> <h1 class="title" id="page-title">Education & Training</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-176" class="node node-page slider-secondary clearfix" about="/training" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="Education & 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> <p>Submission and Reporting:</p> <ul> <li><a href="/sites/g/files/tkssra6501/f/initial-submission-checklist%202023.pdf">Initial Submission Checklist</a></li> <li><a href="/sites/g/files/tkssra6501/f/post-approval-reporting-summary-sheet.pdf">Post Approval Reporting Requirements</a></li> </ul> <p>Consent:</p> <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></li> <li><a href="http://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/gds-checklist.pdf">NIH GDS Policy Consent Checklist</a></li> </ul> <p>Study-Specific Documents:</p> <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></li> <li><a href="http://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/rsv-report-template.pdf">UCSF Routine On-Site Review Form</a></li> </ul> <p>Quality and Compliance Documentation:</p> <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> <h2 class="bodyTextMedium"><a id="pastclasses" name="pastclasses"></a>Past Classes and Slides</h2> <table> <tbody> <tr> <td>Preparing a New IRB Application (currently unavailable)</td> <td><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></td> </tr> <tr> <td><a href="http://hrpp.ucsf.edu/sites/hrpp.ucsf.edu/files/modification-continuing-review-class.pdf" target="_blank">Submitting Modifications and Continuing Reviews</a></td> <td>IRB Introductory Training Archived Webinar (please register to view) or Slides (currently unavailable)</td> </tr> <tr> <td><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></td> <td><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></td> </tr> <tr> <td><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></td> <td> </td> </tr> </tbody> </table> <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&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-d06bfad55762353adf93b6c94be0a70b"> <div class="view-content"> <div> <p class="updated-date"> <span>Last updated: </span> November 5, 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 & 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? 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