Submit Protocol
 
A Sponsor/CRO requesting review of a new protocol must submit:

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 Friday meeting.

Please note: Protocols with Canadian sites are currently reviewed only at Friday Board meetings.