Working with Western IRB

Agenda

GRU IRB Development and ChangesWIRB-Copernicus GroupProcess for transfer of Chesapeake IRB

protocolsProcess for the new WIRB submissions

GRU IRB Development and Changes

• WIRB and IRBNet• Staff Restructure• New and Revised Policies• Changes to the IRB Submission Process• Expedited Review Process

WIRB– Highlights

GRU has joined the National Research Network through the WIRB-Copernicus Group (WCG)

• Western Institutional Review Board (WIRB) • Copernicus Group IRB (CGIRB), • IRBNet, the top research compliance software supporting institutions.

WCG is the world's largest provider of regulatory and ethical review services for human research.

• 8 individual AAHRPP-accredited panels• 100+ experienced board members• 60+ years of combined experience in protocol and study-related review• Only ISO 9001:2008 Certified IRB

WCG can serve as the GRU IRB of record for commercially sponsored trials.

The nation's leading independent

institutional review boards

WIRB– Value Added

GRU has committed to utilize WIRB exclusively for Industry-sponsored clinical trials

 

Efficiency • Innovative “Single Review Solution”• Approximate 5 day approval time when full complete submission provided

Access• GRU will be provided the opportunity to connect with the world’s leading

sponsors and CROs and to expand our repertoire of industry sponsored clinical trials.

• Access to private funding through the top industry sponsors and CRO’s

Oversight• 1 IRB-portal for managing, reviewing, and submitting human subject research

for WIRB (industry sponsored clinical trials) and IRB A, IRB B, and IRB C.

WIRB - External IRB Existing/Active Industry Sponsored Trials

Existing and Active Studies for which Chesapeake IRB (CIRB) is the IRB of record will be transferred to WIRB unless:

• The study is scheduled to close within the next ~3 months• The sponsor explicitly refuses to transfer the protocol

GRU Industry Sponsored Clinical Trials at Chesapeake IRB

  CIRB & GRU

APPROVED

CIRB Approved, GRU Ancillary

Approvals Pending

Submitted to CIRB

TOTAL

Previously Reviewed by WIRB

41 9 1 51

New to WIRB 7 1 0 8TOTAL 48 10 1 59

GRU PIs with Industry Sponsored Clinical Trials at Chesapeake IRB

Afshin AmeriZahid AminAdam Berman Daron FerrisCaralee ForseenSharad GhamandeRita Jerath

Edward KruseAbdullah KutlarAsha Nayak-KapoorVinayak KamathSamir KhleifJohn LueJohn Morgan

GRU PIs with Industry Sponsored Clinical Trials at Chesapeake IRB

Kathleen McKieLaura MulloyKavita Natrajan Cheryl NewmanBetty PaceJeremy PantinOlivier RixeHuda Salman

Richard SchwartzKapil SethiShefali ShahRobert SorrentinoJill TrumbleJohn WhiteJames WildeJose Vazquez

WIRB - External IRB Existing/ Active Industry Sponsored Trials

GRU Process for Transferring Studies• DSPA review of current contracts to determine if revisions are needed

• Telephone contact with Sponsor/CRO to discuss this change (template)

• Letter to Sponsor/CRO to notify of change and requesting response (template)

Support staff are available to support and facilitate transition!

WIRB - External IRB Existing/ Active Industry Sponsored Trials

GRU Process for Transferring Studies• Individual training / support to the Study Team to assist with transfer

IRB submission and current state information from the Chesapeake application

Individual Protocol Submission Form Multi-site application – 51 studies New Study application – 8 studies

Support staff are available to support and facilitate transition!

WIRB - External IRB New Industry Sponsored Trials

All New IRB Submissions for Industry Sponsored Clinical Trials will be submitted to WIRB via IRBNET

Training on WIRB Processes• Commenced Jan 15th

• January 22nd 3:00 p.m. – 5:00 p.m.• Location: Greenblatt Library, AB-0163

• January 29th 3:00 p.m. – 5:00 p.m.• Location: Greenblatt Library, AB-0163

• Additional sessions will be planned

• Individual training will be offered on a continuing basis by contacting GRU IRB Office at EXTERNAL_IRB@GRU.EDU

WIRB Fees• New fee structure• Sponsor will be billed directly from WIRB• Competitive and may be cheaper particularly for multi-center trials.

GRU IRB Office • Will continue to provide Education, Training and Compliance

services. • Fee for this service is being reviewed• On-site resource for WIRB

WIRB - External IRB New Industry Sponsored Trials

GRU WIRB New Study Submission Process

Contact the GRU IRB Office for assistance and trainingEstablish an account in IRBNetComplete the applicable WIRB formsSubmit application and supporting documentation to

WIRB via IRBNet

Process for IRBNet RegistrationPI or SC completes the form at www.irbnet.orgEach user will create own username and passwordProvide contact informationSubmit the New User RegistrationAn activation email will be sent to the user who

must click on the activation link in the email to activate the IRBNet account

Instructional Resource:IRBNet “New User Registration” Energizer (pdf)

Process for new WIRB submissions

Step 1: Notify the GRU IRB Office via email at EXTERNAL _ IRB@gru.edu

Process for new WIRB Submissions

Step 2: The GRU External IRB Administrator will:Assist with determining the applicable

submission forms (i.e. previously reviewed by WIRB/new site or New Application to WIRB)

Provide links/guidance to appropriate documents for submission to WIRB

Assist with ensuring training and access to IRB NET for submitting to WIRB

Scenario 1: WIRB Already Serves as the IRB of Record for the Protocol

Form and Documents Required:GRU External IRB Submission Formhttp://www.gru.edu/research/ohrp/irb/External IRBs.php

Investigator Submission Form for Multi-Center Protocolshttp://www.wirb.com/Pages/DownloadForms.aspx

o A copy of all documents outlined in the above mentioned Investigator Submission Form for Multi-Center Protocols

WIRB will incorporate GRU template language into Sponsor’s ICD template

Scenario 2: WIRB is NOT serving as the IRB of Record for the Protocol

Forms and Documents Required:

GRU External IRB Submission Formhttp://www.gru.edu/research/ohrp/irb/External IRBs.php

WIRB Initial Review Submission Requirementshttp://www.wirb.com/Pages/DownloadForms.aspx

o A copy of all documents outlined in the above mentioned WIRB Initial Review Submission Requirements Form

Sponsor’s ICD template o WIRB will incorporate GRU template language into Sponsor’s ICD

template

Forms Completion Helpful Tips

Investigator Submission Form for Multi-Center Protocols to be submitted with each submission. If the protocol you are submitting has NOT been previously reviewed by WIRB, you cannot use this form; you must use the full length Initial Review Submission Form.

Forms Completion Helpful Tips

WIRB Initial Review Submission Form – must submit a submission form with each protocol you submit for review.

If you have questions:Contact the GRU External IRB Administrator, Michelle

Harper-Meriwether at (706)-721-1478 or mharpermeriwethe@gru.edu.

Forms Completion Helpful Tips WIRB will build researcher profiles, which includes

licenses and CVs submitted by the research team. Unless there’s an update, you are not required to submit these again.

No signature or date required on CVs.

Resources

Call 1-800-562-4789 or email clientservices@wirb.com for assistance

GRU Office External IRB AdministratorMichelle Harper-Meriwethermharpermeriwethe@gru.edu, ext 1-1478