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 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

Study Start-up

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

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

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

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

Cover Page

Submission follow-up Daily reminder s Detailed follow-up 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.

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

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

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

Example

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

Ongoing Study Activity

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.

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

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

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

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 , fax, or OnQ™ portal (Change Request for Sites, Change in Primary Facility Form, or Change in Principal Investigator Form)

Advertisements & Participant Material Submitted by Site Final format Submit via portal, , 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

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

Periodic Site Review / Closing 3 months prior to expiration: send report to sites 5 weeks prior to expiration: reminder to site 4 weeks prior to expiration: 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, s, 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)

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

Quorum Resources

QuorumReview.com Forms Guidance Frequently Asked Questions News and Events

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

OnQ™ Portal

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

Documents & Correspondence NEW Search Features

Documents & Correspondence

Reports

Secure Submission Center

Handbook Search Feature

Handbook Search Topic Highlighted

Contact Information Quorum Site Support Team Telephone (206) M-F 5am – 6pm PST OR Your Institutional Account Manager Megan Simpson Telephone (877) or (206) ext. 341 M-F 8am – 4:30pm PST