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UID:20260903T2250Z-1788475851.4353-EO-136194-1@10.73.15.246
STATUS:CONFIRMED
DTSTAMP:20260926T152120Z
CREATED:20260903T155611Z
LAST-MODIFIED:20260903T161328Z
DTSTART;TZID=America/Chicago:20261013T120000
DTEND;TZID=America/Chicago:20261013T133000
SUMMARY: Good Clinical Practice (GCP) Training
DESCRIPTION: Register via Workday Learning – October 13 | 12 p.m. Presentat
 ion via Zoom by Human Research Quality Assurance Program\, Office of the Vi
 ce Chancellor for Research This training is not recorded. Credit is granted
  only to those attending the entire training session. The two October sessi
 ons 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$8898/rel-task/2998$26720.htm
 ld">Register via Workday Learning - October 13 | 12 p.m.</a></h2><h4>Presen
 tation via Zoom by</h4><p>Human Research Quality Assurance Program\, Office
  of the Vice Chancellor for Research</p><ul><li>This training is not record
 ed.</li><li>Credit is granted only to those attending the entire training s
 ession.</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/wust
 l/email-universal/inst/17815$1514/rel-task/2997$10951.htmld"><em>Please reg
 ister for only </em><em><strong>one</strong> class.</em></a></li></ul><h4>S
 pecial Note Regarding ICH E6 (R3) Training</h4><p>The International Council
  for Harmonisation (ICH) issued updated guidelines for Good Clinical Practi
 ce training. These WashU-sponsored in-person trainings are ICH GCP E6 (R1) 
 and (R2) compliant. These trainings do <strong>NOT </strong>cover ICH GCP E
 6 (R3) requirements. The R3 updates to this training are under review\, and
  the updated WashU-sponsored In-Person training will be offered and announc
 ed via Research News once available. There is not currently an estimated co
 mpletion date for the updated training to launch.</p><p>If your sponsor req
 uires ICH GCP E6 (R3)\, and you wish to satisfy both the this requirement a
 nd <a href="https://research.washu.edu/good-clinical-practices/#Educational
 ">WashU's GCP Training Policy</a> requirement\, you may complete a CITI Pro
 gram 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 complia
 nt.</p><h4>Overview of WashU's GCP Training Requirements</h4><h5>Applicabil
 ity</h5><p>WashU’s <a href="https://research.washu.edu/good-clinical-practi
 ces/#Applicability">Good Clinical Practice Policy</a> requires GCP training
  for all research team members including faculty\, staff\, students\, or ot
 her 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 cl
 inical 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://resea
 rch.washu.edu/good-clinical-practices/#Educational">WashU's GCP Policy</a>\
 , there are three options available to meet training requirements:</p><ul><
 li><a href="https://research.washu.edu/good-clinical-practice-certification
 /#enroll">CITI Program GCP course online</a> (approximately 4-6 hours to co
 mplete)</li><li><a href="https://research.washu.edu/good-clinical-practice-
 certification/#enroll">NIH GCP training course online</a> (approximately 4-
 6 hours to complete)</li><li><a href="https://research.washu.edu/good-clini
 cal-practice-certification/#enroll">WashU-Sponsored In-Person Training</a> 
 (90-minute session) Offered by OVCR in spring and fall.</li></ul><h5>Freque
 ncy</h5><p>GCP training is required every three years per <a href="https://
 research.washu.edu/good-clinical-practices/#Frequency">WashU's GCP Policy</
 a>. Some sponsors may require GCP training more frequently.</p><p>These Was
 hU-Sponsored In-Person Trainings offered by the OVCR are provided each spri
 ng and fall. <em><strong>The next classes will take place in the spring of 
 2027.</strong></em> If your GCP training will expire on or before March 202
 7\, you should consider enrolling in one of these spring courses.</p><h4>Ce
 rtificate of Completion</h4><p>Looking for your GCP certificate from a prio
 r training? Please follow the instructions in the <a href="https://research
 .washu.edu/good-clinical-practice-certification/#certificate">GCP Certifica
 tion FAQ</a> for instructions on how to find your certificate.</p><h4>Quest
 ions?</h4><p>For questions regarding Good Clinical Practice training course
 s\, contact the OVCR at <a href="mailto:ovcrinfo@wustl.edu">ovcrinfo@wustl.
 edu</a>.</p><h4>Helpful Links</h4><ul><li><a href="https://research.washu.e
 du/good-clinical-practices/">Good Clinical Practice Policy</a></li><li><a h
 ref="https://research.washu.edu/good-clinical-practice-certification/">Good
  Clinical Practice Certification FAQ</a></li><li><a href="https://research.
 washu.edu/citi/">CITI Program for GCP & Human Subjects Education</a></li></
 ul><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 Inter
 national Council on Harmonization (ICH) GCP E6\, R1 and R2 training includi
 ng: GCP Overview and Definitions\, the Principles of ICH GCP\, IRB/Investig
 ator/and Sponsor Responsibilities\, Clinical Trail Protocol and Protocol Am
 endments\, 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/
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