INSTITUTIONAL REVIEW BOARD (IRB) FORMS

FORMS FOR INITIAL IRB SUBMISSIONS

The chart below provides guidance for your initial IRB submissions. You can access the applicable forms by clicking the link. The forms are available as Microsoft Word documents. All other IRB forms are available in the list below the chart.

Name of Form	Form Number	Exempt Submission	Expedited Submission	Full IRB Submission
Application for Initial Review (IRB Approval Form)	FRM-301		X	X
Research Description Form	FRM-801	X	X	X
Exempt Research Checklist and Form	FRM-305	X
Expedited Research Categories	FRM-304		X
Research Proposal Submission Checklist	FRM-901			X
**Protocol		X	X	X
Sponsor’s Investigator Brochure				X*
Copy of Device Designation and Number				X*
Affiliated Investigator Agreement	FRM-1001	X	X	X
Unaffiliated Investigator Agreement	FRM-1002	X	X	X
Copy of form FDA-1572				X*
HIPAA Authorization with study title	TMP-509		X	X
Informed Consent Template	TMP-502		X	X
Curriculum Vitae		X	X	X