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) 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
WIRBValue Added 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 CIRBTOTAL Previously Reviewed by WIRB 419151 New to WIRB7108 TOTAL4810159
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 (template) Telephone contact with Sponsor/CRO to discuss this change (template) (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 15 th January 22 nd 3:00 p.m. – 5:00 p.m. Location: Greenblatt Library, AB-0163 January 29 th 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 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.orgwww.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 _ IRB@gru.eduIRB@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 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@example.com. firstname.lastname@example.org
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@example.com for assistance GRU Office External IRB Administrator Michelle Harper-Meriwether firstname.lastname@example.org@gru.edu, ext 1-1478