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WIRB/WCG IRB REVIEW

Stony Brook University has executed a Master Service Agreement that allows SBU IRB to rely on WIRB - Copernicus Group (WCG) for IRB review. Stony Brook Investigators may utilize WCG for industry initiated/sponsored studies, SITE review for protocols when WCG is acting as a Central IRB for a sponsor initiated/funded clinical trial, or when WCG is acting as the mandated sIRB for federally funded research.

Note:

  • The research activity must be submitted in myResearch for local review and acknowledgment before submission to WCG. The Reliance Administrator will copy the PI and Primary Contact when the study is released to WCG via an email to the Account Manager, Jon Gellert.
  • The study team must update the informed consent document with injury language approved by the Office of Sponsored Programs (OSP) and required local context language before submission to WCG.
  • Sign into or create an account on Connexus to complete submissions to WCG and review the User Guide at https://connexus.wcgirb.com/resources for tutorials and demonstrations of selected tasks on the Connexus submission platform.

 

Initial Review Instructions - Submitting to Western IRB (WIRB)

  • Find out if WIRB has already reviewed the research.
    • Ask the sponsor, WIRB Client Services, or WIRB Account Manager Jon Gellert. They will send you the WIRB approved Sponsor Template ICF, and add you to the Connexus Study Workspace by request.
  • Complete the PDF Version of the Initial Review Submission Form.
    • You can download a copy of the form at COM under the “Download Forms” section, or in Connexus.
  • If WIRB has already reviewed the research:
    • Select this option on the Initial Review Submission Form:

If WIRB has already reviewed the research

  • Since WIRB already has the research on file, you only need to submit site specific documents:
    • Initial Review Submission Form
    • PI’s CV & Medical License (only for their first submission)
    • ICF
    • Any Site-Specific Subject Facing Materials (Ads, Diaries, etc.)
  • If WIRB has NOT reviewed the research:
    • Select this option on the Initial Review Submission Form:

If WIRB not already reviewed the research

  • Since WIRB hasn’t reviewed the research, you will also need to submit:
    • Protocol/Grant (final/clean copy)
    • IB/Package Insert/Instructions for Use Manual (if applicable)
    • Any Subject Facing Materials (Ads, Diaries, etc.)
  • Submit via Connexus

 

Submission Guidelines
Submission Guidelines