fully accredited since 2006 Tom Conquergood, CIP Working with Quorum October 13, 2015 Thomas Jefferson University

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

Quorum Submission Process

Initial Site Submissions Required Elements Site Information Questionnaire (F-039) Additional Facility Site Information Questionnaire(s), as needed (F-038) Attachments to Site Information Questionnaire, as Indicated Huntington Hospital/Quorum Review Submission Coversheet and HMH CRC Approval Quorum Required Elements Site Information Questionnaire (F-039) Additional Facility Site Information Questionnaire(s), as needed (F-038) Attachments to Site Information Questionnaire, as indicated One-time CV and audit documentation submission No 1572 required No medical license hardcopy required (for U.S. investigators) Site Submission Checklist (G-010) is not required but Sites are encouraged to use Quorum Review Submission Process

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

1. Complete every question 2. Be proactive 3. Use resources 4. Hold off on submitting until complete Completing Quorum Forms Quorum Review Submission Process Submission Process

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

Example Quorum Review Submission Process

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

Advertisements & Participant Material Site Specific  Investigator Submitted  Final Format  Submit via portal, , fax or with initial submission  48 hour review  Sponsor approval required Model Ads  Model Participant Material is available  Approved with addition of site specific info Quorum Review Submission Process

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: 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. Quorum Review Submission Process

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 Approval Quorum Review Submission Process Submission Process

Ongoing Study Activity

Serious Adverse Event  Related (at least possibly)  Serious  Unanticipated *Must meet all 3 criteria Protocol Deviation/Violation  Risk/benefit ratio, or  Rights, safety, welfare, or  Integrity of study *Must meet one of the above Safety Reporting Guidelines Refer to Safety Reporting Guidelines on Quorum Website (G-036) Ongoing Study Activity

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. Quorum’s Policy – Reportable Events Ongoing Study Activity

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

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

Site Change Request Process 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) Step Ongoing Study Activity

Periodic Site Review and Closing

Site Status Report Check Appropriate Box Check Appropriate Box Periodic Review = All 5 Pages Closing = First 3 Pages 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 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 EXPIRATION 3 months prior to expiration: send report to sites 1 week prior to expiration: Phone calls, s, faxes to site and sponsor Periodic Site Review & Closing

Site Closure Criteria for Closing  No participants  No data collection (including follow-up calls)  Closed by sponsor Closing Acknowledgment  Posted to OnQ Client Portal  Mailed to site/sponsor Periodic Site Review & Closing

Quorum’s Resources

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

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

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 Telephone (877) or (206) Fax (206) Quorum’s Resources: Site Support Team

Questions?