NEW Industry Sponsored IRB Submissions to WIRB

Report
Agenda
 GRU IRB Development and Changes
 WIRB-Copernicus Group
 Process for transfer of Chesapeake IRB
protocols
 Process 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)
The nation's leading independent
• Western Institutional Review Board (WIRB)
institutional review boards
• 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.
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
CIRB Approved,
Submitted to CIRB TOTAL
APPROVED
GRU Ancillary
Approvals Pending
Previously
Reviewed by
WIRB
New to WIRB
TOTAL
41
9
1
51
7
48
1
10
0
1
8
59
GRU PIs with Industry Sponsored Clinical Trials at
Chesapeake IRB







Afshin Ameri
Zahid Amin
Adam Berman
Daron Ferris
Caralee Forseen
Sharad Ghamande
Rita Jerath







Edward Kruse
Abdullah Kutlar
Asha Nayak-Kapoor
Vinayak Kamath
Samir Khleif
John Lue
John Morgan
GRU PIs with Industry Sponsored Clinical Trials at
Chesapeake IRB








Kathleen McKie
Laura Mulloy
Kavita Natrajan
Cheryl Newman
Betty Pace
Jeremy Pantin
Olivier Rixe
Huda Salman








Richard Schwartz
Kapil Sethi
Shefali Shah
Robert Sorrentino
Jill Trumble
John White
James Wilde
Jose 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 [email protected]
WIRB - External IRB
New Industry Sponsored Trials
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
GRU WIRB New Study Submission Process
 Contact the GRU IRB Office for assistance and training
 Establish an account in IRBNet
 Complete the applicable WIRB forms
 Submit application and supporting documentation to
WIRB via IRBNet
Process for IRBNet Registration
 PI or SC completes the form at www.irbnet.org
 Each user will create own username and password
 Provide contact information
 Submit the New User Registration
 An 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 _ [email protected]
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 Form
http://www.gru.edu/research/ohrp/irb/External IRBs.php
 Investigator Submission Form for Multi-Center Protocols
http://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 Form
http://www.gru.edu/research/ohrp/irb/External IRBs.php
 WIRB Initial Review Submission Requirements
http://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
[email protected]
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 [email protected] for
assistance
 GRU Office External IRB Administrator
Michelle Harper-Meriwether
[email protected], ext 1-1478

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