Submit Protocol
 
An Investigator requesting review of a new protocol must submit:
 
 
  • Research Site Submission Form
  • Final Protocol
  • Template Informed Consent Document (In Word Format)
  • Copy of the 1572 Form, QIU Form (Canada) or the Non-IND/Device Studies Form
  • Curriculum vitae of each investigator
  • Copy of the Principal Investigator's current medical license
    		•
     
    And, if applicable:
     
     
  • Investigator Brochure
  • Package Insert or Device Information
    		•
     
    The Board will provide a timely review of your protocol only when all required documents are submitted. Refer to the Submission Checklist for additional information. The submission deadline for new protocols is no later than 3:00 p.m. EST one week prior to a Monday, Wednesday or a Friday meeting.
     
    Please note: Protocols with Canadian sites are currently reviewed only at Friday Board meetings.