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Submission Guide

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Protocol Submission

Printing and completion of paper forms and documents is no longer necessary.  All submission forms are stored in the secured CIRBI platform.

Your protocol will be completed and submitted to Chesapeake IRB using an online submission form.

All correspondence and document transfers between Chesapeake IRB and clients are handled within CIRBI.

The following documents are required for IRB Review:

  • The final Protocol, including any Amendments/Revisions.
  • The Investigator’s Brochure and/or Package Insert per study drug (please also include product information regarding any active comparator if applicable).
  • Copy of the draft Informed Consent Form (ICF).  Must be in MS Word format.
  • IRB Waiver of Oversight, if applicable.
  • Copy of diaries, questionnaires, etc., if applicable.
  • Copy of sponsor generated recruitment material (submitted as a modification).

If you have questions about submissions please contact the CIRBI Help Desk at 1 (866) 992-4724 Monday-Friday 9am to 8pm EST.  Please also feel free to submit your request here:  Contact Us Form

Principal Investigator / Site Submissions

The principal investigator / site submission will be completed and submitted to Chesapeake IRB using an online submission form in CIRBI.

The following documents are required for IRB Review:

  • Current Curricula Vitae (CV) of the Principal Investigator.
  • All recruitment material such as print, radio and television, posters, internet, telephone and other screening scripts, etc. Recruitment material should be submitted as a modification and forwarded to the IRB for review upon finalization and PRIOR to its use
  • Copies of FDA audit reports/letters within the last 5 years, for your site involving all Principal and Sub-Investigators and site response letters to the FDA. If no response was made by the site, please provide an explanation of corrective action taken by this site to address noted deficiencies.
  • IRB Waiver of Oversight, if applicable.

If you have questions about submissions please contact the CIRBI Help Desk at 1 (866) 992-4724 Monday-Friday 9am to 8pm EST.  Please also feel free to submit your request here:  Contact Us Form

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