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Working with Quorum
Allina Health
Megan Simpson, CIPSenior Study Manager Allina Account Manager
Agenda
• About Quorum
• Study Startup
• Ongoing Study Activity
• Quorum Resources
About
Quorum
Stable & ExperiencedAccredited 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 - 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
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
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 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.
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
Reimbursement2 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
SeriousAdverse Event
Single Sites: submit ALL safety information that meets reporting criteria. Sponsor will not submit on your behalf.
Review of Safety Information
Meets Reporting Meets Reporting CriteriaCriteria
Board Review
Does Not Meet Does Not Meet Reporting CriteriaReporting Criteria
Acknowledgement,No Review
Study-wide Safety Information
Study-wide Safety Reports (INDs) &Product Information (IBs, Package Inserts)
F-021
Central SitesSponsor 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 email, 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, 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 Specific Model ads
Site Status Report
Check Check Appropriate Appropriate
BoxBox
• Periodic Site Review: complete entire form
• Closure: complete questions 1-13
Periodic Site Review / Closing
3 m
onths
prior t
o exp
iratio
n:
sen
d rep
ort to
site
s
5 wee
ks p
rior t
o exp
iratio
n:
emai
l rem
inder
to s
ite
4 wee
ks p
rior t
o exp
iratio
n:
e
mai
l rem
inder
to s
ponsor
3 wee
ks p
rior t
o exp
iratio
n:
p
hone re
min
der to
site
2 wee
ks p
rior t
o exp
iratio
n:
ex
piratio
n lette
r to s
ite a
nd sponso
r
1 wee
k prio
r to e
xpira
tion:
phone
calls
, em
ails
, fax
es to
site
and s
ponsor
EXPIRATIO
N
• 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
Reports
Secure Submission Center
Handbook
Search Feature
Handbook
Search TopicHighlighted
Contact Information
Quorum Site Support [email protected]
Telephone (206) 448-4082M-F 5am – 6pm PST
OR Your Institutional Account Manager
Megan SimpsonEmail [email protected]
Telephone (877) 472-9883 or (206) 448-4082 ext. 341M-F 8am – 4:30pm PST