Continuing Review or Completion Form

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PEPPERDINE IRB
CONTINUATION OR COMPLETION OF REVIEW FORM
The IRB is required by federal regulations (45 CFR 46.109) to conduct continuing review of
ongoing projects not less than once per year. Your assistance in meeting these requirements, or
in confirming the completion of your prior IRB approved project, is appreciated.
Date:
IRB Application/Protocol #:
Principal Investigator:
Faculty
Staff
GSBM
GSEP
Administration
School/Unit:
Street Address:
City:
Telephone (work): (
Email Address:
Faculty Supervisor:
School/Unit:
Telephone (work): (
Email Address:
State:
)
@
-
Student
Seaver
Other:
Other
SOL
Zip Code:
Telephone (home): (
)
SPP
-
.
(if applicable)
GSBM
GSEP
Administration
)
@
.
Project Title:
Type of Project (Check all that apply):
Dissertation
Undergraduate Research
Classroom Project
Other:
Seaver
Other:
SOL
SPP
Thesis
Independent Study
Faculty Research
Date of Last IRB Approval:
1. Project Status: The project is (check only 1 box):
CONTINUING with NO CHANGES in procedure, risks, number of subjects, or class of
human subjects since the last review.
REVISED since the last review. To continue the study, you must submit this form, a Request
for Modification form, and a revised IRB application that details the all revisions and the
documents the revised experimental protocol. In this material, please note the revision
dates on each revised page and on the first page of the revised application.
COMPLETED. No further recruitment or contact with human subjects is planned. You may
skip questions 2, 3 and 4, sign, and return this form.
NEVER INITIATED. Please describe:
2. This study involves(d) the following vulnerable populations:
Children
Prisoners
Pregnant women, fetuses or neonates
Cognitively-impaired individuals
Other, please provide detail:
3. Study Site(s):
If you have added a new study site(s) since the last review, attach certification that each
new site approves the use of its facilities for your research.
4. Progress report:
a. Number of Subjects:
i. Approximately how many subjects have you studied/tested or have participated to
date?
ii. Approximately how many subjects have participated since last review? (if zero,
explain).
iii. Approximately how many subjects have yet to be studied?
b. Briefly summarize the research progress and results.
c. Describe any ADVERSE REACTIONS since the last review.
d. Describe any UNANTICIPATED PROBLEMS involving risks to subjects.
e. Describe the circumstances surrounding the WITHDRAWAL of any subjects from this
research.
f. Describe any COMPLAINTS received from subjects about this research.
g. Summarize any recent findings or publications regarding risks or adverse effects with
research similar to your research.
h. Attach (or email) a clean copy of the original consent form(s).
i. Have all investigators on this project completed education on research with human
subjects?
Yes
No
Please attach any new certification forms.
______________________________
Principal Investigator's Signature
____________________________________
Date
______________________________
Faculty Supervisor's Signature
(if applicable)
____________________________________
Date
Appendices/Supplemental Material
Use the space below (or additional pages and/or files) to attach appendices or any supplemental
materials to this application.
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