​Submit Study
A Sponsor/CRO requesting review of a new study must submit:
And, if applicable:
Investigator’s Brochure
Package Insert or Device Information
Recruitment/Study-Related Materials
The submission deadline for full Board review of new studies is no later than 3 p.m. EST one week prior to a Monday, Wednesday or a Friday meeting. Assignment to a Board meeting is dependent upon the complete and accurate submission of all required documents. Studies involving no greater than minimal risk to human subjects may qualify for Minimal Risk Review. Refer to Federally Funded/FWA Study and Transfer of IRB Oversight for Study for additional requirements for these types of study submissions.
Please note: Full Board review of studies with Canadian sites are reviewed only at Friday Board meetings.