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Working with Quorum Allina Health

Working with Quorum Allina Health. Megan Simpson, CIP Senior Study Manager Allina Account Manager. Agenda. About Quorum Study Startup Ongoing Study Activity Quorum Resources. About Quorum. Stable & Experienced. Study Start-up. Definitions. Single Site

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Working with Quorum Allina Health

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  1. Working with Quorum Allina Health Megan Simpson, CIP Senior Study Manager Allina Account Manager

  2. Agenda • About Quorum • Study Startup • Ongoing Study Activity • Quorum Resources

  3. About Quorum

  4. Stable & Experienced

  5. Study Start-up

  6. Definitions • Single Site • Sponsor has not chosen Quorum as the Central IRB, or there is no Sponsor • Central Site • Sponsor has chosen Quorum as the Central IRB

  7. Initial Site Submissions - CentralStreamlined Submission Requirements • Required Elements: • Site Information Questionnaire (F-039) • Additional Facility Site Information Questionnaire(s), as needed (F-038) • Attachments to Site Information Questionnaire, as indicated • Institution Cover Page for Allina Health required for EVERY submission from Allina • One-time CV and audit documentation submission • No medical license hardcopy required (for US investigators) • No 1572 required

  8. Initial Site Submissions - SingleStreamlined Submission Requirements • Required Elements: • Single Site Study Questionnaire (F-036) • Site Information Questionnaire (F-039) • Additional Facility Site Information Questionnaire(s), as needed (F-038) • Attachments to Site Information Questionnaire, as indicated • Institution Cover Page for Allina Health required for EVERY submission from Allina • Protocol • Informed Consent Document • Product Information

  9. Retrospective Chart Review Studies • Required Elements • F-163, Questionnaire for Single Site Research: Retrospective Chart Review • Institution Cover Page for Allina Health required for EVERY submission from Allina • Curriculum Vitae of Principal Investigator

  10. Cover Page

  11. Submission follow-up Incomplete Submission? Detailed follow-up email same day Daily reminder emails OnQ™ Status Report Sent for Board Review once complete Tip: Using the Smart Form Site Information Questionnaire available in the Portal greatly helps reduce submission errors.

  12. Completing the Site Information Questionnaire • Complete every question • Be proactive • Use resources • Hold off on submitting until complete – a pdf copy of the Smart Form SIQ can be saved and sent to the Allina IRB office

  13. Compensation Per visit amount is different for visits or there are unscheduled visits #1 hold reason = compensation Per visit amount is same for all visits

  14. Reimbursement 2 separate questions: 1 for compensation and 1 for reimbursement such as travel & parking costs or gifts Per visit amount is same for all visits Per visit amount is different for visits

  15. Example

  16. Approval • Notice of Approval • Consent Form • Quorum edits for state law compliance & all reg’s • Quorum will insert Allina template language on your behalf

  17. Ongoing Study Activity

  18. Related (at least possibly) Serious Unanticipated *must meet all 3 criteria Risk/benefit ratio, or Rights, safety, welfare, or Integrity of study *must meet one of the above Safety Reporting Guidelines SeriousAdverse Event Protocol Deviation/Violation Single Sites: submit ALL safety information that meets reporting criteria. Sponsor will not submit on your behalf. Refer to Safety Reporting Guidelines on Website (G-036)

  19. Board Review Acknowledgement,No Review Review of Safety Information Meets Reporting Criteria Does Not Meet Reporting Criteria

  20. Study-wide Safety Information F-021 Study-wide Safety Reports (INDs) & Product Information (IBs, Package Inserts) • Central Sites • Sponsor preference: • who submits • how ack is sent to sites • Single Sites • responsible for submitting • ack is sent to site

  21. Change Requests Note: Revised 1572s do not need to be submitted to Quorum

  22. 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 2 Change is reviewed by Quorum. Step 3 Amended Approval and revised consent form issued as applicable, if change is approved. (3 day turnaround)

  23. Submitted by Site Final format Submit via portal, email, fax or with initial submission 48 hour review Submitted by Sponsor Approved with addition of site specific info into placeholders Approved for all sites in the study For Central Sites only Advertisements & Participant Material Site Specific Model ads

  24. Site Status Report • Periodic Site Review: complete entire form • Closure: complete questions 1-13 Check Appropriate Box

  25. Periodic Site Review / Closing • Quorum works hard to prevent lapses in site approval • Board determines review period Single Sites: responsible for completing the SSR & providing a completed Continuing Review Report for Protocols (enrollment data to be completed by the Sponsor) 2 weeks prior to expiration: expiration letter to site and sponsor 3 months prior to expiration: send report to sites 1 week prior to expiration: phone calls, emails, faxes to site and sponsor 5 weeks prior to expiration: email reminder to site 4 weeks prior to expiration: email reminder to sponsor 3 weeks prior to expiration: phone reminder to site EXPIRATION

  26. Site Closure • Closing Acknowledgment • Posted to OnQ Client Portal • Mailed to site/sponsor Criteria for closing • No participants • No data collection (including follow-up calls) • Closed by sponsor/CRO

  27. Quorum Resources

  28. QuorumReview.com • Forms • Guidance • Frequently Asked Questions • News and Events

  29. OnQ™ Portal • Electronic submission • Secure access to all study documents • Sortable site status reports • Access to archived Board rosters, pricing, and consent form templates

  30. OnQ™ Portal

  31. OnQ™ Client Portal Find Board Info Find Approvals Get Updates Find Guidance Smart Form & Submit Online

  32. Documents & Correspondence NEW Search Features

  33. Documents & Correspondence

  34. Reports

  35. Reports

  36. Secure Submission Center

  37. Handbook Search Feature

  38. Handbook Search Topic Highlighted

  39. Contact Information • Quorum Site Support Team • Sitesupport@quorumreview.com • Telephone (206) 448-4082 • M-F 5am – 6pm PST • OR • Your Institutional Account Manager • Megan Simpson • Email MSimpson@quorumreview.com • Telephone (877) 472-9883 or • (206) 448-4082 ext. 341 • M-F 8am – 4:30pm PST

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