Clinical Drug Trials | State of California - Department of Justice

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}); </script> </div> </div> </div>   <div class="container-fluid"> <div class="row"> </div> </div> <div class="main-container container"> <div class="row"> <section class="col-sm-9"> <a id="main-content"></a> <h1 class="page-header">Clinical Drug Trials</h1> <ol class="breadcrumb"><li><a href="/">Home</a></li> <li><a href="/research" class="active-trail">Research Advisory Panel</a></li> <li class="active">Clinical Drug Trials</li> </ol> <div class="region region-content"> <div id="block-system-main" class="block block-system"> <div class="content"> <div id="node-538" class="node node-page clearfix" about="/research/clinical" typeof="foaf:Document"> <span property="dc:title" content="Clinical Drug Trials" 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 clearfix"> <div class="field field-name-body field-type-text-with-summary field-label-hidden"><div class="field-items"><div class="field-item even" property="content:encoded"><p>All single or multicenter clinical drug trials involving Schedule I and Schedule II controlled substances as a main study are required to be approved by the Research Advisory Panel of California prior to the start-up of any sites in California. The sponsor conducting the study submits the application for review. Clinical drug trial sponsors include pharmaceutical companies, contract research organizations (CRO), NIH, NIDA, NARC, etc. Below are the items required for Panel review: <ol type="a"> <li>Cover Letter<br> The cover letter should be in the form of a request letter from the sponsor conducting the single or multicenter clinical trial study, requesting Panel review. It should include: <ul style="list-style-type:disc"> <li>The title of the study</li> <li>The anticipated startup and completion dates or timeline</li> <li>The number of California sites planned, and the estimated number of subjects in California, plus the total number of subjects in the study</li> <li>The name, mailing address, phone number, and email address of a contact person of the sponsor or CRO. (*It is the study’s responsibility to update RAPC when the contact information changes.)</li> <li>Confirmation of IRB and FDA IND approvals (attach copies of approval letters)</li> </ul> </li> <br> <li>Research Protocol <ul style="list-style-type:disc"> <li>The IRB-approved version (required)</li> </ul> </li> <br> <li>Template Informed Consent Form(s): See <a href="/research/consent">California Informed Consent Form Guidelines</a> <ul style="list-style-type:disc"> <li>The IRB-approved version (required)</li> <li>A completely filled out <a href="https://oag.ca.gov/sites/all/files/agweb/pdfs/research/consent-checklist.pdf">Informed Consent Form Check List, pdf </a>is required</li> <li>Studies that involve DNA/genetic testing, or that collect samples for DNA/genetic testing, or that may share biological samples with others who may conduct DNA/genetic testing on the samples, must provide a separate DNA Informed Consent Form. For guidelines on drafting a valid DNA consent, follow link: <a href="https://oag.ca.gov/system/files/media/rapc-dna-genetic-informed-consent-guidelines.pdf">DNA/Genetic Informed Consent</a>.</li> </ul> </li> <br> <li>Investigator's Brochure(IB)</li> <br> <li>List of each California site, including the address and the Principal Investigator’s (PI) name and email address at each site</li> </li> </ol> </p> <p>The Research Advisory Panel grants the approval to the sponsor or CRO conducting the clinical drug trial, not the individual PI's or sites participating in the study. Therefore, the sponsor or CRO conducting the clinical drug trial is required to submit the study applications to the Panel, not the individual PI's or sites participating in the study.</p> <p>Research studies shall not be started, and research subjects cannot be enrolled or screened, prior to the Panel’s approval of the study.</p></div></div></div> </div> </div> </div> </div> </div>    </section> <aside class="col-sm-3" role="complementary"> <div class="region region-sidebar-second"> <div id="block-block-152" class="block block-block"> <div class="content"> <div class="CS"> <h3>Research Advisory Panel</h3> <ul class="CSList"> <li><a href= "/research">Research Advisory Panel Home</a></li> <li><a href="/research/guide">Guidelines</a></li> <li><a href= "/research/research">Application Forms</a></li> <li><a href="/research/clinical">Clinical Drug Trials</a></li> <li><a href= "/research/consent">CA Informed Consent Form Guidelines</a></li> <li><a href= "/research/meeting">Meeting Dates And Deadlines</a></li> <li><a href= "/research/progress">Annual Progress Report Requirement</a></li> <li><a href= "/research/panel">Panel Members</a></li> <li><a href= "https://www.deadiversion.usdoj.gov/schedules/index.html" target="_blank">DEA Controlled Substance Listings</a></li> <li><a href= "/research/annual">Annual Report to the<br> Governor & Legislature of California</a></li> <li><a href= "/research/contact">Contact Us</a></li> </ul> </div> </div> </div><div id="block-block-153" class="block block-block"> <div class="content"> <h2>Appendices</h2> <h4 class="subAlt">California Health and Safety Codes:</h4> <div style="text-align: left; margin-bottom: 25px; padding-left:7px;"> <a href= "/sites/all/files/agweb/pdfs/research/safety_11213.pdf">§11213 - <span style="letter-spacing:-0.04em;">Persons & Researches Using Control Substances, pdf</span><br /> <a href= "/sites/all/files/agweb/pdfs/research/safety_11480.pdf">§11480 & 11481 - <span style="letter-spacing:-0.05em;">Research Advisory Panel, pdf</span><br /> <a href= "/sites/default/files/statutes-11603-11604.pdf">§11603 & 11604 - Attorney General, pdf<br /> <a href= "/sites/all/files/agweb/pdfs/research/safety_24172.pdf">§24172 - <span style="letter-spacing:-0.04em;">Experimental Subject's Bill of Rights, pdf</span><br /> <a href="/sites/all/files/agweb/pdfs/research/safety_24173.pdf">§24173 - Informed Consent, pdf</a><br /> </div> <h4>California Experimental Subject's Bill of Rights:</h4>  <div style="text-align: left; margin-bottom: 25px; padding-left:7px;"> <a href= "/sites/all/files/agweb/pdfs/research/bill-of-rights-eng.pdf">English Version, pdf</a><br /> <a href= "/sites/all/files/agweb/pdfs/research/bill_of_rights_sp.pdf">Spanish Version (En Español), pdf</a><br /> For different language versions: Go to<br /> <a href="http://ora.research.ucla.edu/OHRPP/Pages/BillofRights.aspx" style="display: block; padding-left: 15px;" target ="_blank"><abbr title="The UCLA Office of the Human Research Protection Program">OHRPP</abbr>, Research Participant <br />Bill of Rights </a> </div> <h4>Annual Report (AR) of the <abbr title="Research Advisory Panel of California">RAPC</abbr> from 2005:</h4> <div style="text-align: left; margin-bottom: 25px; padding-left:7px;"> <a href= "/system/files/media/2023-rapc-annual-report.pdf">53rd AR - 2023, pdf</a><br /><br /> <a href= "/system/files/media/52nd-annual-report-2022.pdf">52nd AR - 2022, pdf</a><br /><br /> <a href= "/sites/default/files/fifty-first-annual-report.pdf">51st AR - 2021, pdf</a><br /><br /> <a href= "/sites/default/files/forty-ninth-fiftieth-annual-report.pdf">49th & 50th AR - 2019 & 2020, pdf</a><br /><br /> <a href= "/sites/all/files/agweb/pdfs/research/fourty-eighth-annual-report.pdf">48th AR - 2018, pdf</a><br /><br /> <a href= "/sites/all/files/agweb/pdfs/research/forty-seventh-annual-report.pdf">47th AR - 2017, pdf</a><br /><br /> <a href= "/sites/all/files/agweb/pdfs/research/fourty-sixth-annual-report.pdf">46th AR - 2016, pdf</a><br /><br /> <a href= "/sites/all/files/agweb/pdfs/research/fourty-fifth-annual-report.pdf">45th AR - 2015, pdf</a><br /><br /> <a href= "/sites/all/files/agweb/pdfs/research/forty-fourth-annual-report.pdf">44th AR - 2014, pdf</a><br /><br /> <a href= "/sites/all/files/agweb/pdfs/research/forty_third_annual_report.pdf">43rd AR - 2013, pdf</a><br /><br /> <a href= "/sites/all/files/agweb/pdfs/research/forty_second_annual_report.pdf">42nd AR - 2012, pdf</a><br /><br /> <a href= "/sites/all/files/agweb/pdfs/research/forty_first_annual_report.pdf">41st AR - 2011, pdf</a><br /><br /> <a href= "/sites/all/files/agweb/pdfs/research/fortieth_annual_report.pdf">40th AR - 2010, pdf</a><br /><br /> <a href= "/sites/all/files/agweb/pdfs/research/thirty_ninth_annual_report.pdf">39th AR - 2009, pdf</a><br /><br /> <a href= "/sites/all/files/agweb/pdfs/research/thirty_eighth_annual_report.pdf">38th AR - 2008, pdf</a><br /><br /> <a href= "/sites/all/files/agweb/pdfs/research/thirty_seventh_annual_report.pdf">37th AR - 2007, pdf</a><br /><br /> <a href= "/sites/all/files/agweb/pdfs/research/thirty_sixth_annual_report.pdf">36th AR - 2006, pdf</a><br /><br /> <a href= "/sites/all/files/agweb/pdfs/research/thirty_fifth_annual_report.pdf">35th AR - 2005, pdf</a><br /><br /> </div> </div> </div> </div> </aside>  </div> </div> <footer class="footer container"> <div class="region region-footer"> <div id="block-block-373" class="block block-block"> <div class="content"> <div class="row hidden-print"> <div class="container sect-separator"> <div class="col-xs-12 col-md-1"> <img class="footer-seal" src="/sites/default/themes/custom2017/oag2017/img/seal.png" alt="State of California Department of Justice - 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