working with quorum allina health megan simpson, cip senior study manager allina account manager

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 TeamSitesupport@quorumreview.com

Telephone (206) 448-4082M-F 5am – 6pm PST

OR Your Institutional Account Manager

Megan SimpsonEmail MSimpson@quorumreview.com

Telephone (877) 472-9883 or (206) 448-4082 ext. 341M-F 8am – 4:30pm PST