Submit Protocol

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

•  Sponsor/CRO New Study Submission Form
• Final Protocol
• Template Informed Consent Document

      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 noon (12:00 p.m. EST) one week prior to a Wednesday or a Friday meeting.