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UID:20260903T2250Z-1788475851.4458-EO-136198-1@10.73.15.246
STATUS:CONFIRMED
DTSTAMP:20260927T015631Z
CREATED:20260903T160816Z
LAST-MODIFIED:20260903T161511Z
DTSTART;TZID=America/Chicago:20261014T070000
DTEND;TZID=America/Chicago:20261014T083000
SUMMARY: Good Clinical Practice (GCP) Training
DESCRIPTION: Register via Workday Learning – October 14 | 7 a.m. Presentati
 on via Zoom by Human Research Quality Assurance Program\, Office of the Vic
 e Chancellor for Research This training is not recorded. Credit is granted 
 only to those attending the entire training session. The two October sessio
 ns are the same class\, with the same content presented […]
X-ALT-DESC;FMTTYPE=text/html: <h2 class="bq-citation"><a href="https://www.
 myworkday.com/wustl/email-universal/inst/15972$8860/rel-task/2998$26720.htm
 ld">Register via Workday Learning - October 14 | 7 a.m.</a></h2><h4>Present
 ation via Zoom by</h4><p>Human Research Quality Assurance Program\, Office 
 of the Vice Chancellor for Research</p><ul><li>This training is not recorde
 d.</li><li>Credit is granted only to those attending the entire training se
 ssion.</li><li>The two October sessions are the same class\, with the same 
 content presented at each of them. <a href="https://www.myworkday.com/wustl
 /email-universal/inst/17815$1514/rel-task/2997$10951.htmld"><em>Please regi
 ster for only </em><em><strong>one</strong> class.</em></a></li></ul><h4>Sp
 ecial Note Regarding ICH E6 (R3) Training</h4><p>The International Council 
 for Harmonisation (ICH) issued updated guidelines for Good Clinical Practic
 e training. These WashU-sponsored in-person trainings are ICH GCP E6 (R1) a
 nd (R2) compliant. These trainings do <strong>NOT </strong>cover ICH GCP E6
  (R3) requirements. The R3 updates to this training are under review\, and 
 the updated WashU-sponsored In-Person training will be offered and announce
 d via Research News once available. There is not currently an estimated com
 pletion date for the updated training to launch.</p><p>If your sponsor requ
 ires ICH GCP E6 (R3)\, and you wish to satisfy both the this requirement an
 d <a href="https://research.washu.edu/good-clinical-practices/#Educational"
 >WashU's GCP Training Policy</a> requirement\, you may complete a CITI Prog
 ram or NIH course that has been updated with the R3 guidelines. See the <a 
 href="https://research.washu.edu/good-clinical-practice-certification/#r3">
 GCP Certification page</a> for information on which courses are R3 complian
 t.</p><h4>Overview of WashU's GCP Training Requirements</h4><h5>Applicabili
 ty</h5><p>WashU’s <a href="https://research.washu.edu/good-clinical-practic
 es/#Applicability">Good Clinical Practice Policy</a> requires GCP training 
 for all research team members including faculty\, staff\, students\, or oth
 er personnel listed on an IRB application for research meeting the <a href=
 "https://hrpo.wustl.edu/guidance-3/research-guide/#Research-Guide-Table-of-
 Contents">definition of a clinical trial</a>. The policy applies to all cli
 nical trials regardless of support including\, but not limited to all NIH\,
  other federal\, industry\, foundation and departmental sponsored clinical 
 trials.​</p><h5>Educational Requirements</h5><p>Per <a href="https://resear
 ch.washu.edu/good-clinical-practices/#Educational">WashU's GCP Policy</a>\,
  there are three options available to meet training requirements:</p><ul><l
 i><a href="https://research.washu.edu/good-clinical-practice-certification/
 #enroll">CITI Program GCP course online</a> (approximately 4-6 hours to com
 plete)</li><li><a href="https://research.washu.edu/good-clinical-practice-c
 ertification/#enroll">NIH GCP training course online</a> (approximately 4-6
  hours to complete)</li><li><a href="https://research.washu.edu/good-clinic
 al-practice-certification/#enroll">WashU-Sponsored In-Person Training</a> (
 90-minute session) Offered by OVCR in spring and fall.</li></ul><h5>Frequen
 cy</h5><p>GCP training is required every three years per <a href="https://r
 esearch.washu.edu/good-clinical-practices/#Frequency">WashU's GCP Policy</a
 >. Some sponsors may require GCP training more frequently.</p><p>These Wash
 U-Sponsored In-Person Trainings offered by the OVCR are provided each sprin
 g and fall. <em><strong>The next classes will take place in the spring of 2
 027.</strong></em> If your GCP training will expire on or before March 2027
 \, you should consider enrolling in one of these spring courses.</p><h4>Cer
 tificate of Completion</h4><p>Looking for your GCP certificate from a prior
  training? Please follow the instructions in the <a href="https://research.
 washu.edu/good-clinical-practice-certification/#certificate">GCP Certificat
 ion FAQ</a> for instructions on how to find your certificate.</p><h4>Questi
 ons?</h4><p>For questions regarding Good Clinical Practice training courses
 \, contact the OVCR at <a href="mailto:ovcrinfo@wustl.edu">ovcrinfo@wustl.e
 du</a>.</p><h4>Helpful Links</h4><ul><li><a href="https://research.washu.ed
 u/good-clinical-practices/">Good Clinical Practice Policy</a></li><li><a hr
 ef="https://research.washu.edu/good-clinical-practice-certification/">Good 
 Clinical Practice Certification FAQ</a></li><li><a href="https://research.w
 ashu.edu/citi/">CITI Program for GCP & Human Subjects Education</a></li></u
 l><p><em>This in-person training complies with the expectations set by the 
 NIH’s National Center for Advancing Translational Sciences (NCATS) for GCP 
 training for CTSA Consortium Hubs and meets the minimum criteria for Intern
 ational Council on Harmonization (ICH) GCP E6\, R1 and R2 training includin
 g: GCP Overview and Definitions\, the Principles of ICH GCP\, IRB/Investiga
 tor/and Sponsor Responsibilities\, Clinical Trail Protocol and Protocol Ame
 ndments\, Investigator Brochure and Essential Documents for the Conduct of 
 Clinical Trials.</em></p>
CATEGORIES:Human Subjects Research
ORGANIZER;CN="Danica":MAILTO:danica.johnson@wustl.edu
URL;VALUE=URI:https://research.washu.edu/events/event/good-clinical-practic
 e-gcp-training-2/
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