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Working with Quorum: Quorum Submission Process, Site Review, and Resources

This resource provides information on the Quorum submission process, ongoing study activities, periodic site reviews and closings, as well as helpful resources for researchers. Learn how to complete Quorum forms, handle compensation and reimbursement, submit advertisements and participant materials, follow up on submissions, and more.

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Working with Quorum: Quorum Submission Process, Site Review, and Resources

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  1. Working with QuorumOctober 13, 2015Thomas Jefferson University Tom Conquergood, CIPtconquergood@quorumreview.com

  2. Quorum Submission Process Ongoing Study Activity Periodic Site Review/Closing Quorum Resources Q&A Presentation Outline

  3. Quorum Submission Process

  4. Quorum Review Submission Process Initial Site Submissions           

  5. Quorum Review Submission Process Cover Page for Submission Required for all TJU Submissions

  6. Quorum Review Submission Process Completing Quorum Forms Complete every question Be proactive Use resources Hold off on submitting until complete

  7. Quorum Review Submission Process #1Hold Reason = Compensation Compensation 2nd Checkbox: per visit amount is same for all visits 3rd Checkbox: per visit amount is different for all visits

  8. Quorum Review Submission Process Example

  9. Quorum Review Submission Process Reimbursement is different from compensation Reimbursement 1st Checkbox: per visit amount is same for all visits 2nd Checkbox: per visit amount is different for all visits

  10. Quorum Review Submission Process Advertisements & Participant Material

  11. Quorum Review Submission Process Submission Follow-up Incomplete Submission? Detailed follow-up email same day Daily reminder emails Sent for Board Review once complete OnQ™ Status Report Tip: The Site Submission Checklist (G-010) is not required, but may be a helpful way to ensure that your site submits all needed information to Quorum with your initial submission.

  12. Quorum Review Submission Process Approval Notice of Approval Consent Form • Compliant with all state laws • Please inform Quorum of any state laws the model consent does not appear to address

  13. Ongoing Study Activity

  14. Ongoing Study Activity Safety Reporting Guidelines Refer to Safety Reporting Guidelines on Quorum Website (G-036)

  15. Ongoing Study Activity Quorum’s Policy – Reportable Events Unanticipated events that involve risk must be reported promptly to the IRB Promptly = 10 business days Reportable events must be reported using Quorum’s forms.

  16. Ongoing Study Activity Review of Safety Information Meets Reporting Criteria Board Review Does Not Meet Reporting Criteria Acknowledgement, No Review

  17. Ongoing Study Activity The sponsor will submit all Study-wide Safety information Quorum sends IRB acknowledgment to Site Study-wide Safety Information Study-wide Safety Reports (INDs) Product Information (IBs, Package Inserts)

  18. Ongoing Study Activity Change Requests Address Site Contact Info Compensation Change Request Form for Sites (CRFS) Business Name Translated Consent Principal Investigator Participant Emergency Numbers Note: Revised 1572s do not need to be submitted to Quorum

  19. Ongoing Study Activity Site Change Request Process Complete and submit appropriate change form(s) via email, fax, or OnQ™ portal (Change Request for Sites, Change in Primary Facility Form, or Change in Principal Investigator Form) Step 1 Step Change is reviewed by Quorum 2 Amended Approval and revised consent form issued as applicable, if change is approved (3-day turnaround) Step 3

  20. Periodic Site Review and Closing

  21. Periodic Site Review & Closing Site Status Report Periodic Review = All 5 Pages Check Appropriate Box Closing =First 3 Pages

  22. Periodic Site Review & Closing Don’t let your approval lapse! Study approval period typically 6 or 12 months Quorum will contact you several times in advance of expiration Periodic Site Review / Closing 2 weeks prior to expiration: expiration letter to site and sponsor 5 weeks prior to expiration:email reminder to site 1 week prior to expiration: Phone calls, emails, faxes to site and sponsor 3 months prior to expiration:send report to sites 3 weeks prior to expiration:phone reminder to site 4 weeks prior to expiration:email reminder to sponsor EXPIRATION

  23. Periodic Site Review & Closing Site Closure

  24. Quorum’s Resources

  25. Quorum’s Resources CITI Training Human Subjects Protection Training is a requirement of conducting research CITI access is offered by Quorum www.citiprogram.org Register & Choose Institution

  26. Quorum’s Resources:Client Portal OnQ™ Portal Benefits • Electronic submission • Secure access to all study documents • Sortable status reports • Access to archived Board rosters, pricing, and consent form templates

  27. Quorum’s Resources:Site Support Team Dedicated to answering site questions Available from 5am-5pm PT (8am-8pm ET) Can provide assistance at every step in the study process Site Support Team • Contact Information • Emailsitesupport@quorumreview.com • Telephone (877) 472-9883 or (206) 448-4082 • Fax (206) 448-4193

  28. Questions?

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