Fully accredited since 2006 Tom Conquergood, CIP Working with Quorum October 13, 2015 Thomas...

fully accredited since 2006

Tom Conquergood, [email protected]

Working with QuorumOctober 13, 2015Thomas 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 IndicatedHuntington Hospital/Quorum Review Submission Coversheet and HMH CRC Approval Email

Quorum Required ElementsSite 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 ReviewSubmission Process

Cover Page for Submission

Required for all TJU Submissions


1. Complete every question2. Be proactive3. Use resources4. Hold off on submitting until complete

Completing Quorum Forms

Quorum Review Submission Process

#1 Hold Reason = Compensation

Compensation

2nd Checkbox: per visit amount is

same for all visits

3rd Checkbox: per visit amount is

different for all visits


ExampleQuorum Review

Submission Process

Reimbursement is different from compensation

Reimbursement

1st Checkbox: per visit amount is

same for all visits

2nd Checkbox: per visit amount is

different for all visits


Advertisements & Participant MaterialSite 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


Submission Follow-up

Daily reminder emails

Detailed follow-up email same day

OnQ™ Status ReportSent for Board Review

once complete

IncompleteSubmission?

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.


• 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

ApprovalQuorum Review

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)


• 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


Review of Safety Information

Acknowledgement, No Review

Board ReviewMeets Reporting Criteria

Does Not Meet Reporting Criteria


• 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)


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


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)

Step1

Step2

Step3


Periodic Site Review and Closing

Site Status Report

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 wee

ks prio

r to ex

piratio

n:

email

reminder

to site

4 wee

ks prio

r to ex

piratio

n:

email

reminder

to sponso

r

3 wee

ks prio

r to ex

piratio

n:

phone rem

inder to si

te

2 wee

ks prio

r to ex

piratio

n:

expira

tion le

tter t

o site

and sp

onsor

EXPIRATIO

N

3 months p

rior t

o expira

tion:

send re

port to si

tes

1 wee

k prio

r to ex

piratio

n:

Phone call

s, em

ails,

faxes

to site

and sp

onsor


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


Quorum’s Resources

• Human Subjects Protection Training is a requirement of conducting research

• CITI access is offered by Quorum

• www.citiprogram.org

• Register & Choose Institution

CITI TrainingQuorum’s Resources

http://www.citiprogram.org/

Benefits• Electronic submission• Secure access to all study documents• Sortable status reports• Access to archived Board

rosters, pricing, and consent form templates

OnQ™ PortalQuorum’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 InformationEmail [email protected]

Telephone (877) 472-9883 or (206) 448-4082Fax (206) 448-4193

Quorum’s Resources:Site Support Team

mailto:[email protected]

Questions?

Fully accredited since 2006 Tom Conquergood, CIP Working with Quorum October 13, 2015 Thomas...

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