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Western IRB Submission Checklist

Note: Submission of electronic documents is preferred (excluding the UMDNJ Application for Review by WIRB; original signatures required)

Download checklist

PDF ChecklistPDF Version Word Checklist Word Version

WIRB Initial Review Submission Form
Original UMDNJ Application for Review by WIRB
Final Signed Protocol Final signed protocol
Final signed investigators brochure/device Final signed investigator's brochure/device
Copy of signed FDA 1572

Copy of signed FDA 1572 - insert the following for question #5:
Western Institutional Review Board
3535 Seventh Avenue SW
Olympia, WA 98502

Amended FDA 1572 Amended FDA 1572s
CV of Principal Investigator with State License information CV of Principal Investigator with State License information ( if already on file at WIRB, only yearly updates needed)
CVs of other investigators CVs of other investigators (if already on file at WIRB, only yearly updates needed)
UMDNJ Investigator Financial Disclosure Form UMDNJ Investigator Financial & Other Personal Interests Disclosure Form (Parts 1 & 2) signed by PI(s) and Department Chair(s). Sponsor financial disclosure form will not be accepted.
http://www.umdnj.edu/oppmweb/Policies/HTML/AcademicAff/00-01-20-89_00.html
Consent Form template Consent Form Template
Assent Form Template Assent Form Template
Translated Consents Translated Consents
Department Letterhead Department letterhead (with UMDNJ logo - 1 sheet)
Advertisements Advertisements
Regulatory Requirements Regulatory Documents (warning letters, etc)
Clinical Trial Agreements Clinical Trials Agreement (draft is acceptable)
Study budget Study Budget (draft is acceptable)
CITI Education UMDNJ Human Subjects Protection Education Program certificate of completion (for each study personnel) CITI Education
Additional approvals required

Additional approvals required:

Approved UMDNJ - University Hospital: Research Protocol Pre-Registration Form http://ocr.umdnj.edu/3steps.cfm

Robert Wood Johnson University Hospital: Research Utilization Group Allocation of Resources Form

UMDNJ - University Behavioral HealthCare - Human Research Form

CINJ: Scientific Review Board approval notice

Submission Checklist Submission Checklist

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