Submit Study

Submit Study

An investigator requesting review of a new study must submit:

  •  Single Site Study Submission Form

  • Final Protocol

  • Template Informed Consent Document(s) (Microsoft Word format required)

  • Curriculum Vitae (CV) of Principal Investigator (PI) / Qualified Investigator (QI)

And, if applicable:

  • *Curriculum Vitae (CV) of all Sub-Investigators

  • Recruitment/Study-Related Materials

  • Investigator’s Brochure

  • Package Insert or Device Information

  • Clinical Research Budget (Canada) 

  • Copy of the Principal Investigator's current medical/professional license (Mississippi and Puerto Rico only)

*These items are not required for non-interventional studies.

The submission deadline for full Board Review of new studies is 3 p.m. EST one (1) 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. 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.