Charles Drew University of Medicine and Science

Charles R. Drew University of Medicine and Science

Office for the Protection of Human Subjects

Institutional Review Board

Checklist for Application for Exempt Study Review

CDU IRB #:
Project Title:
Principal Investigator:
Date:
o  Please submit TWO complete sets (original and one copy) of the following required and applicable documents to IRB (Building F) or e-mail to .
o  Applications must be typed.
o  An incomplete submission may delay the review of your application.
o  Please use the checklist to assemble your submission packet.
P / Required Documents
This completed checklist for Application for Exempt Study Review
Submission Cover Letter (Form 100)
Application for Exempt Study Review (signed and dated) (Form 104)
Research Protocol (Click here for template)
Certificate of Education in Human Subjects Research and HIPAA for all research personnel
Completed Research Overview Committee (ROC) Review Form
P / Required/Applicable Documents – Consent Form
Consent Form(s) (Form 114)
Study Information Sheet (Form 118)
Consent Script
Participant Bill of Rights (English) (Form 123)
Participant Bill of Rights (Spanish) (Form 124)
P / Applicable Documents - Protocol
Additional listing of co-investigators (Form 104a)
Study Instruments (e.g., surveys, questionnaires, etc.)
Participant Recruitment Materials (e.g., contact letters, flyers, posters, brochures, radio/TV ads, etc.)
Data Extraction Form
P / Applicable Documents - HIPAA (to examine medical chart)
HIPAA Consent Form (Form H100)
HIPAA Waiver of Consent (Form H101)
P / Other Applicable Documents
Curriculum vitae/biosketch/resumé of key personnel to justify their qualifications for a particular role in the study
Copy of grant application
IRB approval letter from collaborating sites with IRB
Letters of support from outside facilities or agencies, if used as research sites. These letters must be on the facility’s letterhead.
Other (specify): ______

Rev. 6/2015a Form 103