Working with Quorum
October 13, 2015
Thomas Jefferson University
fully accredited since 2006
Tom Conquergood, CIP
tconquergood@quorumreview.com
Presentation Outline
•Quorum Submission Process
• Ongoing Study Activity
• Periodic Site Review/Closing
• Quorum Resources
• Q&A
Quorum Submission
Process
Quorum Review
Submission Process
Initial Site Submissions
Quorum Required Elements
Required Elements
 Site Information Questionnaire (F-039)
 Additional Facility Site Information Questionnaire(s), as needed (F-038)
Additional
Facility
Site Information
Questionnaire(s),
Attachments
to Site
Information
Questionnaire,
as indicated
 as needed (F-038)
CV and audit documentation submission
Attachments
to Site Information Questionnaire, as
 One-time
Indicated
No 1572
required
 Huntington
Hospital/Quorum Review Submission
license hardcopy required (for U.S. investigators)
 No medical
Coversheet
and HMH CRC Approval Email
Submission Checklist (G-010) is not required but Sites are
 Site
encouraged to use
Site Information Questionnaire (F-039)
Quorum Review
Submission Process
Cover Page for Submission
Required for all TJU
Submissions
Quorum Review
Submission Process
Completing Quorum Forms
1.
2.
3.
4.
Complete every question
Be proactive
Use resources
Hold off on submitting until complete
Quorum Review
Submission Process
Compensation
#1 Hold Reason = Compensation
2nd Checkbox: per
visit amount is
same for all visits
3rd Checkbox: per
visit amount is
different for all visits
Quorum Review
Submission Process
Example
Quorum Review
Submission Process
Reimbursement
Reimbursement is different from compensation
1st Checkbox: per
visit amount is
same for all visits
2nd Checkbox: per
visit amount is
different for all visits
Quorum Review
Submission Process
Advertisements & Participant Material
Site Specific
Model Ads
 Investigator Submitted
 Model Participant Material is
available
 Final Format
 Approved with addition of site
specific info
 Submit via portal, email, fax or
with initial submission
 48 hour review
 Sponsor approval required
Quorum Review
Submission Process
Submission Follow-up
Incomplete
Submission?
Detailed follow-up
email same day
Daily reminder emails
OnQ™ Status Report
Sent for Board Review
once complete
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
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
Ongoing Study Activity
Ongoing Study Activity
Safety Reporting Guidelines
Serious Adverse Event
Protocol Deviation/Violation
 Related (at least possibly)
 Risk/benefit ratio, or
 Serious
 Rights, safety, welfare, or
 Unanticipated
 Integrity of study
*Must meet all 3 criteria
*Must meet one of the above
Refer to Safety Reporting Guidelines on Quorum Website (G-036)
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.
Ongoing Study Activity
Review of Safety Information
Meets Reporting
Criteria
Board Review
Does Not Meet
Reporting Criteria
Acknowledgement,
No Review
Ongoing Study Activity
Study-wide Safety Information
Study-wide Safety
Reports (INDs)
Product Information
(IBs, Package Inserts)
• The sponsor will submit all Study-wide
Safety information
• Quorum sends IRB acknowledgment to
Site
Ongoing Study Activity
Change Requests
Address
Site Contact Info
Business Name
Principal
Investigator
Change Request
Form for Sites
(CRFS)
Compensation
Translated
Consent
Participant
Emergency Numbers
Note: Revised 1572s do not need to be submitted to Quorum
Ongoing Study Activity
Site Change Request Process
Step
1
Step
2
Step
3
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)
Change is reviewed by Quorum
Amended Approval and revised consent form issued
as applicable, if change is approved (3-day
turnaround)
Periodic Site Review
and Closing
Periodic Site Review & Closing
Site Status Report
Periodic Review =
All 5 Pages
Check
Appropriate
Box
Closing =
First 3 Pages
Periodic Site Review & Closing
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
Site Closure
Criteria for Closing
Closing Acknowledgment
 No participants
 Posted to OnQ Client Portal
 No data collection (including
follow-up calls)
 Mailed to site/sponsor
 Closed by sponsor
Quorum’s Resources
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
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
Quorum’s Resources:
Site Support Team
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
Contact Information
Email sitesupport@quorumreview.com
Telephone
(877) 472-9883 or (206) 448-4082
Fax
(206) 448-4193
Questions?