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 Accredited Fully Accredited by AAHRPP (the Association for Accreditation of Human Research Protection Programs); Reaccredited June 2009 Time-tested Quorum Review has been providing IRB services for 19 years; has longstanding relationships with industry & researchers Strong Framework One of the largest IRBs in the nation, with approx. 170 employees (many with CIP certification) International Boards available for the review of US and Canadian Studies

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

12. Completing the Site Information Questionnaire 1.Complete every question 2.Be proactive 3.Use resources 4.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 same for all visits Per visit amount is different for visits or there are unscheduled visits #1 hold reason = compensation

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. Safety Reporting Guidelines 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 Refer to Safety Reporting Guidelines on Website (G-036) Protocol Deviation/Violation Serious Adverse Event Single Sites: submit ALL safety information that meets reporting criteria. Sponsor will not submit on your behalf.

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

20. Study-wide Safety Information Study-wide Safety Reports (INDs) & Product Information (IBs, Package Inserts) F-021 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 Step 1 Step 2 Step 3 Change is reviewed by Quorum. Amended Approval and revised consent form issued as applicable, if change is approved. (3 day turnaround) 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)

23. Advertisements & Participant Material 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 Site SpecificModel ads

24. Site Status Report CheckAppropriateBox Periodic Site Review: complete entire form Closure: complete questions 1-13

25. Periodic Site Review / Closing 3 months prior to expiration: send report to sites 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 2 weeks prior to expiration: expiration letter to site and sponsor 1 week prior to expiration: phone calls, emails, faxes to site and sponsor EXPIRATION 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)

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

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 Approvals Get Updates Smart Form & Submit Online Find Board Info Find Guidance

32. Documents & Correspondence NEW Search Features

33. Documents & Correspondence

34. 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.comMSimpson@quorumreview.com Telephone (877) 472-9883 or (206) 448-4082 ext. 341 M-F 8am – 4:30pm PST