Mount Carmel Institutional Review Board

Office of Research Affairs/IRB Office
Mount Carmel Corporate Services Center
6150 East Broad Street
Columbus, OH 43213
Phone: 614-546-4325 | Fax: 614-546-4328
Email:

RESEARCH STUDY

CONTINUING REVIEW

A)  Administrative Information

IRB Assigned Protocol #
Study Title:
Protocol Expiration Date : / Review Frequency:
Principal Investigator
Name:
Address:
Telephone: / Fax: / E-mail:
Primary Contact / Coordinator [if other than PI]:
Name:
Address:
Telephone: / Fax: / E-mail:
Has there been a change in principal investigator or study personnel since the last review? / No
Yes, indicate change:
B)  Study Status (choose appropriate category):
Has not yet begun (Skip to Section F)
Open to Enrollment
Closed to Enrollment - in data analysis or patient follow up.
Terminate study- all study activities are complete.
C) Subject Accrual Numbers:
Subjects / During this Reporting Period / Since Initial Approval of this Study
# Consented to participate or if a chart review
number of charts reviewed
# Currently on study or in follow up
# Completed study participation
# Withdrew/Terminated from study
Provide details
# Expired
Provide details
# Lost to follow-up
Provide details
D)  Informed Consent
Is written consent required? / Yes
No, please explain:
Have any Non-English speaking
subjects been consented? / Yes, please explain:
No
Attach a copy of the consent document signed by the last subject enrolled (required unless no subjects have been enrolled or enrollment was closed prior to your last renewal).
E) HIPAA
Was a HIPAA Waiver of Authorization granted by the IRB at initial review? / Yes
No- HIPAA Authorization incorporated into consent form
F) Adverse Events – section not applicable to Chart Reviews
Since the last IRB Review
# of internal/local events:
# of internal/local deaths:
Attach any events not previously reported
G) Amendments/Revisions/Modifications
Since initial review or last renewal have any amendments/revisions/ modifications been submitted to the IRB? / No
Yes, indicate the type(s):
Informed consent document List date(s):
Amendments or other changes List date(s):

** PLEASE ATTACH AN UPDATED CONFLICT OF INTEREST FORM FOR ALL RESEARCH PERSONNEL**

H) Other Information Relevant to the Research Study:
Since the last IRB review, have there been any investigator suspensions or terminations?
No Yes, please explain:
Since the initial IRB review or last renewal have you received an interim report on the study from an external monitoring board such as a data and safety monitoring board (DSMB) or an annual report from a sponsor or cooperative group or have there been any publications resulting from this study?
No Yes, please attach a copy of the report:
Since the last IRB review, have any subjects or others complained about the research?
No Yes, please explain:
Since the last review have there been any factors that would alter the risk/benefit assessment of this study?
No Yes, please explain:
Has a regulatory inspection (e.g., FDA, OHRP) occurred at the site since the start of the study or since your last continuing review?
No Yes
If yes, was a Form FDA 483 or other list of objectionable observations issued? No Yes
If yes, attach the observations and your response letter.
Has any subject sought compensation for injury associated with this study at your site that has not previously been reported?
No Yes, please explain:
Have there been any changes in the qualifications of the PI, including a revocation, sanction, or suspension of his/her state medical license since the start of the study or since the last continuing review?
No Yes, please provide update curriculum vitae or other documentation
PRINCIPAL INVESTIGATOR’S SIGNATURE
Date:
Printed Name:
Signature /
I attest that the information contained herein is a true and accurate representation of my research study to date.

IRB Research Study Renewal Form

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