tconquergoodquorumreviewcom Working with Quorum October 13 2015 Thomas Jefferson University Quorum Submission Process Ongoing Study Activity Periodic Site ReviewClosing Quorum Resources ID: 378509
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Tom Conquergood, CIPtconquergood@quorumreview.com
Working with Quorum
October 13, 2015
Thomas Jefferson UniversitySlide2
Quorum Submission Process
Ongoing Study Activity
Periodic Site Review/Closing Quorum Resources Q&A
Presentation OutlineSlide3
Quorum
Submission ProcessSlide4
Initial Site Submissions
Required
ElementsSite 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 Email
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 ProcessSlide5
Cover Page for Submission
Required for all TJU Submissions
Quorum Review
Submission ProcessSlide6
Complete every question
Be proactive
Use resourcesHold off on submitting until complete
Completing Quorum Forms
Quorum Review
Submission ProcessSlide7
#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 ProcessSlide8
Example
Quorum Review
Submission ProcessSlide9
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 ProcessSlide10
Advertisements & Participant Material
Site Specific
Investigator
Submitted
Final
Format
Submit
via portal, email, 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 ProcessSlide11
Submission Follow-up
Daily reminder emails
Detailed follow-up email same day
OnQ™ Status Report
Sent for Board Review once complete
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 ProcessSlide12
Notice of Approval Consent FormCompliant with all
state laws
Please inform Quorum of any state laws the model consent does not appear to address
Approval
Quorum Review
Submission ProcessSlide13
Ongoing Study ActivitySlide14
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 ActivitySlide15
Unanticipated events that involve risk must be reported promptly to the IRBPromptly = 10 business days Reportable events must be reported using Quorum’s forms.
Quorum’s Policy – Reportable Events
Ongoing Study ActivitySlide16
Review of Safety Information
Acknowledgement, No Review
Board Review
Meets Reporting
Criteria
Does Not Meet
Reporting Criteria
Ongoing Study ActivitySlide17
The sponsor will submit all Study-wide Safety informationQuorum sends IRB acknowledgment to Site
Study-wide Safety Information
Study-wide Safety Reports (INDs)
Product Information
(IBs, Package Inserts)
Ongoing Study ActivitySlide18
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 ActivitySlide19
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 email, fax, or OnQ™ portal (Change Request for Sites, Change in Primary Facility Form, or Change in Principal Investigator Form)
Step
1
Step
2
Step
3
Ongoing Study ActivitySlide20
Periodic Site Review
and ClosingSlide21
Site Status Report
Check
Appropriate
Box
Periodic Review =
All 5
PagesClosing = First 3 Pages
Periodic Site Review & ClosingSlide22
Don’t let your approval lapse!Study approval period typically 6 or 12 monthsQuorum will contact you several times in advance of expiration
Periodic Site Review / Closing
5 weeks prior to expiration:
email reminder to site
4 weeks prior to expiration:
email 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, emails, faxes
to site and sponsor
Periodic Site Review & ClosingSlide23
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 & ClosingSlide24
Quorum’s ResourcesSlide25
Human Subjects Protection Training is a requirement of conducting researchCITI access is offered by Quorum
www.citiprogram.org
Register & Choose InstitutionCITI Training
Quorum’s ResourcesSlide26
BenefitsElectronic submission
Secure access to all study documents
Sortable status reportsAccess to archived Board
rosters, pricing, and
consent form templates
OnQ™ Portal
Quorum’s Resources:
Client PortalSlide27
Dedicated to answering site questionsAvailable from 5am-5pm PT (8am-8pm ET)Can provide assistance at every step in the study process
Site Support Team
Contact Information
Email
sitesupport@quorumreview.com
Telephone
(877) 472-9883 or (206) 448-4082Fax (206) 448-4193Quorum’s Resources:
Site Support TeamSlide28
Questions?