Working with Western IRB

1. Working with Western IRB

2. Agenda • GRU IRB Development and Changes • WIRB-Copernicus Group • Process for transfer of Chesapeake IRB protocols • Process for the new WIRB submissions

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

4. 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

5. 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.

6. 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

7. 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

8. 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

9. 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!

10. 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!

11. 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

12. 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

13. 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

14. 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)

15. Process for new WIRB submissions Step 1: Notify the GRU IRB Office via email at EXTERNAL_ IRB@gru.edu

16. 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

17. 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 • 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

18. 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 • A copy of all documents outlined in the above mentioned WIRB Initial Review Submission Requirements Form • Sponsor’s ICD template • WIRB will incorporate GRU template language into Sponsor’s ICD template

19. 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.

20. 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.

21. 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.

22. Resources • Call 1-800-562-4789 or email clientservices@wirb.com for assistance • GRU Office External IRB Administrator Michelle Harper-Meriwether mharpermeriwethe@gru.edu, ext 1-1478