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">Budgeting Resources</a></li> <li class="last leaf menu-mlid-20056"><a href="/research-fee-schedule" title="Patient care costs for a study budget">Research Fee Schedule</a></li> </ul></li> <li class="last leaf menu-mlid-9026"><a href="/news">News</a></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> > <span class="breadcrumb-page-title">How to Activate a Study</span></div></div></div> <h1 class="title" id="page-title">How to Activate a Study with Us</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-806" class="node node-page slider-secondary clearfix" about="/how-activate-study-us" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="How to Activate a Study with Us" 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 Office of Clinical Trials Activation is here to help you with Study Start-up, when you reach this point. The Operations team facilitates the start-up process within OCTA and is your main point of contact. Reach the Operations team at <a href="/cdn-cgi/l/email-protection#b1d2ddd8dfd8d2d0ddc5c3d8d0ddc2f1c4d2c2d79fd4d5c4"><span class="__cf_email__" data-cfemail="3556595c5b5c56545941475c54594675405646531b505140">[email protected]</span></a>.</p> </div></div></div> <div class="paragraphs-items paragraphs-items-field-paragraph-sections paragraphs-items-field-paragraph-sections-full paragraphs-items-full"> <div class="field field-name-field-paragraph-sections field-type-paragraphs field-label-hidden"><div class="field-items"><div class="field-item even"><div class="entity entity-paragraphs-item paragraphs-item-textarea"> <div class="content"> <div class="field field-name-field-pg-textarea-text field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even"><div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <h3>1. Determine if your study needs a Coverage Analysis</h3> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Review the <a href="/coverage-analysis">Coverage Analysis</a> page of our website. You may use the <a href="https://ucsf.co1.qualtrics.com/jfe/form/SV_0AmS09jBvSgOx3o">Coverage Analysis Determination Form</a> to determine whether your study requires Coverage Analysis.</p> <ul> <li style="margin: 0in;">If the study <strong>requires a Coverage Analysis</strong>, proceed with Step 2. Submit to OCTA.</li> </ul> <ul> <li>If the study <strong>does NOT require a Coverage Analysis</strong>:</li> </ul> <p style="margin-left: 40px;">This is considered a non-clinical research billing (non-CRB) study since study-required activities will not generate charges in APeX (UCSF’s electronic Epic-based, Medical Record System). You are not required to submit this study to OCTA. For additional services:</p> <ul style="margin-left: 40px;"> <li style="margin-left: 40px;"><strong>OnCore Calendar Build Services Only</strong> <ul> <li style="margin-left: 40px;">If you plan on tracking study participants in OnCore, please complete the <a href="http://ucsf.service-now.com/ucsfit?id=ucsf_sc_cat_item&sys_id=1501da561bf95490fd5d85507e4bcbde">Clinical Trial Activation Request Form </a>and indicate you are requesting calendar build services only. Please be sure to provide your Submission ID generated from the Coverage Analysis Determination Form.</li> </ul> </li> <li style="margin-left: 40px;"><strong>Non-CRB New APeX Study Request</strong> <ul> <li style="margin-left: 40px;">If you need access to APeX research features when visit tracking is not required, please: <ul> <li style="margin-left: 40px;">First ensure the study has a finalized Coverage Analysis, or complete the <a href="https://ucsf.co1.qualtrics.com/jfe/form/SV_0AmS09jBvSgOx3o">Coverage Analysis Determination Form</a> to verify and document the "CA Not Required" status.</li> <li style="margin-left: 40px;">Next submit an <a href="https://ucsf.service-now.com/ess/study_request">New APeX Study Request</a>. Within the Service Catalog, navigate to, and click the New APeX Study Request item. Please note that you will be required to provide the Submission ID generated from the Coverage Analysis Determination form, and an Award Number/Chart String/Chart of Accounts (COA).</li> </ul> </li> <li style="margin-left: 40px;">APeX Research features include: <ul> <li style="margin-left: 40px;">Upload study consents using APeX Consents Activity</li> <li style="margin-left: 40px;">Flagging patients as research participants in APeX</li> <li style="margin-left: 40px;">Review patients' charts (e.g., for registries)</li> <li style="margin-left: 40px;">MyChart recruitment</li> <li style="margin-left: 40px;"><a href="https://rise.articulate.com/share/3Ucnf0Gk2dhOdJiyzEfbGIm6WvndWo4r#/">MD Link</a> for study monitor access</li> <li style="margin-left: 40px;">Using the research note in APeX to differentiate it from the clinical note</li> <li style="margin-left: 40px;">Notifying study staff of changes in research participant visits or when they visit the Emergency Department for adverse event reporting</li> <li style="margin-left: 40px;">Alerting study staff of abnormal research-related results</li> </ul> </li> </ul> </li> <li style="margin-left: 40px;"><strong> Budgeting Services</strong> <ul> <li style="margin-left: 40px;">Please visit the <a href="https://trialactivation.ucsf.edu/budgeting">Budgeting section</a> on our website.</li> </ul> </li> </ul> <p style="margin-left: 40px;"> </p> </div> </div> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <h3>2. Submit to OCTA</h3> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p><a class="btn--small btn--white--underline" href="https://ucsf.service-now.com/ucsfit?id=ucsf_sc_cat_item&sys_id=1501da561bf95490fd5d85507e4bcbde">Clinical Trial Activation Request Form</a></p> <h4>Required documents for submission to OCTA:</h4> <div class="wysiwyg_twocols layout--50-50"> <div class="wysiwyg_twocols--first bg--transparent"> <p><u>Industry Sponsored Studies:</u></p> <ul> <li>Protocol</li> <li>Draft consent form</li> <li>Sponsor budget (draft)</li> <li>Contract (draft)</li> </ul> </div> <div class="wysiwyg_twocols--second bg--transparent"> <p><u>Non-Industry Sponsored Studies:</u></p> <ul> <li>Protocol</li> <li>Draft consent form</li> <li>Funding document (any kind of document that shows proof of funding)</li> </ul> </div> </div> <h4>Additional recommended information for submission to OCTA:</h4> <ul> <li>Data Safety Monitoring Committee Charter</li> <li>IND/IDE FDA May Proceed Letters</li> <li>Investigator's Brochure</li> <li>Lab, Imaging, Pharmacy, and other applicable manuals</li> <li>Sponsor and CRO Contacts</li> </ul> <div> <hr /> <ul> <li><a href="https://irb.ucsf.edu/new-study">Submit to the IRB </a>at the same time as submitting to OCTA.</li> <li>For industry sponsored studies, OCTA will submit to <a href="https://icd.ucsf.edu/">Industry Contracts Division </a>on your behalf for contract review and execution.</li> <li>For non-industry sponsored studies, please contact <a href="https://osr.ucsf.edu/find-my-support">Office of Sponsored Research</a> for budget and contract services.</li> </ul> </div> </div> </div> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <h3>3. Locate the status of your study within OCTA</h3> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>There are three methods to locate the activation status of your study within OCTA:</p> <ul> <li>Use the <a href="https://tableau.ucsf.edu/views/CurrentActivationPipelineDashboard/90Days?%3Aembed=y&%3Aiid=1&%3AisGuestRedirectFromVizportal=y">Current Activation Pipeline Dashboard</a> to track progress and status. <ul style="margin-left: 40px;"> <li>Using your UCSF My Access Credentials, find details on this and other OCTA dashboards, how to gain access and training quick guides at <a href="https://wiki.library.ucsf.edu/pages/viewpage.action?spaceKey=OnCore&title=OCTA+Tableau+Dashboards">OCTA Tableau Dashboards - OnCore Wiki - Wiki@UCSF</a>.</li> </ul> </li> <li>Review the <a href="https://ucsf.box.com/s/inleeisvjupiqog96057ogc9w219wa64">OCTA Task List in OnCore</a>.</li> <li>Email the OCTA Operations Team at <a href="/cdn-cgi/l/email-protection#a0c3ccc9cec9c3c1ccd4d2c9c1ccd3e0d5c3d3c68ec5c4d59fd3d5c2cac5c3d49de1c3d4c9d6c1d4c9cfce859290f3d4c1d4d5d3859290f2c5d1d5c5d3d4"><span class="__cf_email__" data-cfemail="2f4c434641464c4e435b5d464e435c6f5a4c5c49014a4b5a">[email protected]</span></a>. </li> </ul> </div> </div> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <h3>4. Review & Approve Coverage Analysis & Budget</h3> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The Principal Investigator and Study Team will be required to review and approve the Coverage Analysis and Budget before moving forward. If OCTA is not providing budget serivces, the Study Team will only review the Coverage Analysis. Use the applicable review guide below.</p> <ul> <li><a href="https://ucsf.box.com/s/e3vtx97a2bvd48c897bvfnh9t1sbnapx">Coverage Analysis and Internal Budget Review Guide</a></li> <li><a href="https://ucsf.box.com/s/sop376w2awr8u1gj1svj8bhc4vxhdndg">Coverage Analysis Review Guide</a></li> <li><a href="/coverage-analysis">More on Coverage Analysis</a></li> <li><a href="/octa-budgeting-services">More on Budgeting</a></li> </ul> </div> </div> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <h3>5. Notify OCTA of IRB Approval</h3> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <h4>Required Documents for OCTA Finalization:</h4> <ul style="margin-left: 40px;"> <li>IRB Approval Letter</li> <li>IRB Approved Protocol <ul style="margin-left: 40px;"> <li><strong>NOTE: </strong>OCTA cannot finalize if the IRB approved protocol version is different than the protocol version submitted to OCTA</li> </ul> </li> <li>IRB Approved Consent Form(s) <ul style="margin-left: 40px;"> <li><strong>NOTE: </strong><u>If using the UCSF IRB</u>, ensure your ICF cost language meets <a href="http://irb.ucsf.edu/consent-form-guidelines-and-suggested-wording#Are-there-any-costs-to-me-for-taking-part-in-this-study">UCSF standards</a> prior to receiving IRB approval. If you have any questions or need additional assistance with your ICF cost language, please contact our OCTA Quality Improvement & Compliance Officer, <a href="/cdn-cgi/l/email-protection#e1ab84808f8f80cfab948d8ea194829287cf848594cfde9294838b848295dca8a2a7c4d3d1a28e9295c4d3d1ad808f8694808684">Jeanna Julo</a>. <u>If using consent forms in non-UCSF format</u>, <a href="https://irb.ucsf.edu/relying-other-irbs#If-using-consent-forms-in-nonUCSF-format">follow HRPP guidance</a>.</li> </ul> </li> </ul> <p>If UCSF IRB reviewed, OCTA will obtain final documents in iRIS.</p> <p>If external IRB reviewed, please provide OCTA with the above approved documents, and ensure the UCSF IRB has acknowledged the reliance.</p> <p> </p> </div> </div> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <h3>6. Complete Quality Assurance</h3> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <ul> <li>Principal Investigator to complete 700U and/or Policy 11 Conflict of Interest form in DocuSign, <a href="https://compliance.ucsf.edu/faqs-oec#I-have-questions-regarding-how-to-complete-my-State-of-California-form-700U-disclosure">see FAQ.</a></li> <li>Principal Investigator and Department Chair to review & approve in eProposal, see<a href="https://ucsf.box.com/s/91crxe4h5lgz59o4knma9tfx96bjfpxj"> eProposal Quick Guide for Approving Proposals</a>.</li> <li>OCTA will notify the Industry Contracts Division to proceed with contract execution.</li> <li>More on <a href="https://compliance.ucsf.edu/financial-conflict-interest-research">Financial Conflict of Interest in Research</a>.</li> </ul> </div> </div> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <h3>7. Contract Execution</h3> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The Office of Sponsored Research, Industry Contracts Division Officer will negotiate and perform the final contract execution.</p> <ul> <li>For industry sponsored studies, OCTA will submit to <a href="https://icd.ucsf.edu/">Industry Contracts Division </a>on your behalf for contract review and execution.</li> <li>For non-industry sponsored studies, please contact <a href="https://osr.ucsf.edu/find-my-support">Office of Sponsored Research</a> for budget and contract services.</li> </ul> <p>To locate the ICD Officer assigned to your study, please view the Staff List in the OnCore PC Console, using this <a href="https://trialactivation.ucsf.edu/sites/g/files/tkssra876/f/wysiwyg/Accessing%20the%20Task%20List3.15.21.1AAH.pdf">quick guide</a>. For questions about the contract please contact <a href="/cdn-cgi/l/email-protection#8be2e5effef8fff9f2e8e4e5fff9eae8fff8cbfee8f8eda5eeeffe"><span class="__cf_email__" data-cfemail="bcd5d2d8c9cfc8cec5dfd3d2c8cedddfc8cffcc9dfcfda92d9d8c9">[email protected]</span></a><strong>.</strong></p> </div> </div> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <h3>8. Submit New APeX Study Request</h3> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <h4>Prior to submitting a New APeX Study Request, be sure that:</h4> <p> </p> <p><strong>If the study requires a Coverage Analysis:</strong></p> <ul style="margin-left: 40px;"> <li>OCTA has finalized your coverage analysis</li> <li><a href="https://trialactivation.ucsf.edu/sites/g/files/tkssra876/f/wysiwyg/Document%20an%20IRB%20review%209.15.2020.pdf">IRB Approval information is recorded in the OnCore protocol record</a></li> <li><a href="https://trialactivation.ucsf.edu/sites/g/files/tkssra876/f/wysiwyg/Add%20a%20reviewed%20consent%20form%20name%209.11.2020.pdf">Consent Form details are recorded in the OnCore protocol record</a></li> <li><a href="https://trialactivation.ucsf.edu/sites/g/files/tkssra876/f/wysiwyg/Recording%20Participating%20Institutions%20and%20Study%20Sites%209.11.2020.pdf">Accurate institutions and study sites are entered into OnCore</a></li> <li>Contracts and Grants Accounting (CGA) has provided an Award Number/Chart String/Chart of Accounts (COA)</li> </ul> <p> </p> <p><strong>If the study does NOT require a Coverage Analysis:</strong></p> <ul style="margin-left: 40px;"> <li>You have completed the <a href="http://ucsf.co1.qualtrics.com/jfe/form/SV_0AmS09jBvSgOx3o">Coverage Analysis Determination Form</a> to verify and formally document the "CA Not Required" status.</li> <li>You submit a non-clinical research billing New APeX Study Request</li> <li>Please note that you will be required to provide the Submission ID generated from the Coverage Analysis Determination form, and an Award Number/Chart String/Chart of Accounts (COA)</li> </ul> <p> </p> <p><strong>If the study requires a Coverage Analysis but does not utilize APeX:</strong></p> <ul style="margin-left: 40px;"> <li>OCTA has finalized your coverage analysis</li> <li>You submit a non-clinical research billing New APeX Study Request</li> <li>Please note that you will be required to provide the Submission ID generated from the Coverage Analysis Determination form, and an Award Number/Chart String/Chart of Accounts (COA)</li> </ul> <hr /> <h4>Then use this form for a New APeX Study Request:</h4> <p><a class="btn--small btn--white--underline" href="https://ucsf.service-now.com/ess/study_request">New APEX STUDY REQUEST</a></p> </div> </div> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <h3>9. Open Study to Accrual in OnCore</h3> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Prior to enrolling study participants, ensure the OnCore protocol record is up to date and open to accrual.</p> <ul> <li><a href="https://ucsf.box.com/s/a2nben2ylv1c10h4xt08il6pjwej5pb0">Update Staff List</a> - <span style="font-size:11.0pt"><span style="font-family:Arial">All studies require one study team member to have OnCore access to manage the staff list and protocol status within the systems. Please follow the steps for <a href="/oncore-account-creation-training">training and account requests</a> on our website. </span></span></li> <li><a href="https://trialactivation.ucsf.edu/sites/g/files/tkssra876/f/wysiwyg/Recording%20Participating%20Institutions%20and%20Study%20Sites%209.11.2020.pdf">Update Study Sites</a></li> <li><a href="https://trialactivation.ucsf.edu/sites/g/files/tkssra876/f/wysiwyg/Document%20an%20IRB%20review%209.15.2020.pdf">Document IRB reviews in OnCore</a></li> <li><a href="https://trialactivation.ucsf.edu/sites/g/files/tkssra876/f/wysiwyg/Add%20a%20reviewed%20consent%20form%20name%209.11.2020.pdf">Document IRB approved consent forms in OnCore</a></li> <li><a href="https://trialactivation.ucsf.edu/sites/g/files/tkssra876/f/wysiwyg/Update%20Open%20to%20Accrual%209.1.2020_0.pdf">Open study to Accrual</a></li> </ul> </div> </div> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <h3>10. Submit Amendments to OCTA</h3> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p><a class="btn--small btn--white--underline" href="https://ucsf.service-now.com/ucsfit?id=ucsf_sc_cat_item&sys_id=1501da561bf95490fd5d85507e4bcbde">Clinical Trial Activation Request Form</a></p> <p>When submitting a protocol amendment to the UCSF or external IRB, also submit to OCTA. Study protocol or budget amendments often require an update to the IRB application, consent forms, OnCore calendar, coverage analysis, and/or budget. Begin at step #2 and submit amended documents to OCTA to initiate updates to the OnCore calendar build, coverage analysis, budget and contract.</p> <h3>Required Documents for OCTA Amendments:</h3> <div class="wysiwyg_twocols layout--50-50"> <div class="wysiwyg_twocols--first bg--transparent"> <p><u>Industry Sponsored Studies:</u></p> <ul> <li>Updated protocol</li> <li>Redlined/tracked protocol</li> <li>Updated consent form (if applicable)</li> <li>Updated sponsor budget (if applicable)</li> <li>Updated contract (if applicable)</li> </ul> </div> <div class="wysiwyg_twocols--second bg--transparent"> <p><u>Non-Industry Sponsored Studies:</u></p> <ul> <li>Updated protocol</li> <li>Redlined/tracked protocol</li> <li>Updated consent form (if applicable)</li> <li>Updated funding document (if applicable)</li> </ul> </div> </div> <p> </p> </div> </div> <p> </p> </div></div></div> </div> </div> </div></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-block-36" class="block block-block"> <div class="content"> <p><a class="btn--small btn--more--reverse" href="https://oncore.ucsf.edu/forte-platform-web/login">OnCore | UCSF ONLY | USE YOUR MYACCESS CREDENTIALS</a></p> <hr /> <p><a class="btn--small btn--white--underline" href="https://ucsf.service-now.com/ucsfit?id=ucsf_sc_cat_item&sys_id=1501da561bf95490fd5d85507e4bcbde">Clinical Trial Activation Request Form</a></p> <hr /> <p><a class="btn--small btn--white--underline" href="https://ucsf.service-now.com/ess/study_request">APEX Research REQUEST FORM</a></p> <hr /> <p><a class="btn--small btn--white--underline" href="https://ucsf.co1.qualtrics.com/jfe/form/SV_0AmS09jBvSgOx3o">Coverage Analysis DETERMINATION FORM</a></p> </div> </div> <div id="block-block-46" class="block block-block"> <h3>Activation Workflows</h3> <div class="content"> <p><a class="btn--small btn--blue" href="https://ucsf.app.box.com/file/1354939194794?s=1jkzd4thvso7rua6g06wd3osk49gf2tu">OCTA ACTIVATION - INDUSTRY</a></p> <hr /> <p><a class="btn--small btn--blue" href="https://ucsf.app.box.com/s/m91fd3hbogo1o1yhkq6r9fy14osme0wv">OCTA ACTIVATION - NON-INDUSTRY</a></p> <p> </p> </div> </div> </div> </div> </div> </div> </div></div> <div id="footer"> <div class="section"> <div class="footer-bottom"> <nav aria-label="Footer Navigation" class="footer--navigation"> <ul> <li><a href="/cdn-cgi/l/email-protection#c7a4abaea9aea4a6abb3b5aea6abb487b2a4b4a1e9a2a3b2">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>© 2025 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>