Transcript Document

Working with Quorum
Allina Health
Megan Simpson, CIP
Senior Study Manager
Allina Account Manager
Agenda
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•
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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
Incomplete
Detailed follow-up
email same day
Submission?
Daily reminder emails
OnQ™ Status Report
Sent for Board Review
once complete
Tip: Using the Smart Form Site Information Questionnaire available in
the Portal greatly helps reduce submission errors.
Completing the Site Information
Questionnaire
1.
2.
3.
4.
Complete every question
Be proactive
Use resources
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
#1 hold reason = compensation
Per visit amount is
same for all visits
Per visit
amount is
different for
visits or there
are
unscheduled
visits
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
Serious
Adverse Event
Protocol
Deviation/Violation
• Related
• Risk/benefit ratio, or
(at least possibly)
• Rights, safety, welfare, or
• Serious
• Integrity of study
• Unanticipated
*must meet one of the
*must meet all 3 criteria
above
Single Sites: submit ALL safety information that
meets reporting criteria. Sponsor will not submit on
your behalf.
Refer to Safety Reporting Guidelines on Website (G-036)
Review of Safety Information
Meets Reporting
Criteria
Board Review
Does Not Meet
Reporting Criteria
Acknowledgement,
No Review
Study-wide Safety Information
F-021
Study-wide Safety Reports (INDs) &
Product Information (IBs, Package Inserts)
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
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)
Step
2
Change is reviewed by Quorum.
Step
3
Amended Approval and revised consent form issued as
applicable, if change is approved. (3 day turnaround)
Advertisements & Participant Material
Site Specific
• Submitted by Site
• Final format
• Submit via portal, email,
fax or with initial
submission
• 48 hour review
Model ads
• Submitted by Sponsor
• Approved with addition
of site specific info into
placeholders
• Approved for all sites in
the study
• For Central Sites only
Site Status Report
Check
Appropriate
Box
•
Periodic
Site Review:
complete
entire form
•
Closure:
complete
questions
1-13
Periodic Site Review / Closing
• 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
•
•
•
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Forms
Guidance
Frequently Asked Questions
News and Events
OnQ™ Portal
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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 Board
Info
Find
Approvals
Get
Updates
Smart Form
& Submit
Online
Find
Guidance
Documents & Correspondence
NEW Search
Features
Documents & Correspondence
Reports
Reports
Secure Submission Center
Handbook
Search
Feature
Handbook
Search Topic
Highlighted
Contact Information
Quorum Site Support Team
[email protected]
Telephone (206) 448-4082
M-F 5am – 6pm PST
OR
Your Institutional Account Manager
Megan Simpson
Email [email protected]
Telephone (877) 472-9883 or
(206) 448-4082 ext. 341
M-F 8am – 4:30pm PST