Application for Continuing Review Institutional Review Board (IRB) Chicago State University

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Application for Continuing Review
Institutional Review Board (IRB)
Chicago State University
Principal Investigator:
Email Address:
Phone Number:
CSU Extension:
IRB Protocol #:
Project Title:
1. Please check one box.
□The study has never enrolled subjects. (Skip to Progress Report).
□ The study is closed to new enrollment, and subjects are being followed up only.
□The study is continuing to enroll new subjects.
□ Data collection is now complete and the study is open for data analysis only.
□ Data collection was complete at the last continuing review and the study is open for data analysis only
(skip to question 8).
2. How many subjects have been enrolled in the study since the last continuing review? ___
3. How many subjects have been enrolled since the beginning of the study? ____
Please answer the following for the period since the last continuing review, or the beginning of the study
if there has been no previous continuing review.
4. Have there been any changes to the protocol, consent documents or materials not requested by
amendment? □ Yes □ No
5. Have there been any adverse events or complaints, or whthdrawals by subjects? □ Yes
□ No
6. Have there been any unexpected events or findings that change the risk level experienced by
subjects? □ Yes
□ No
If yes to 5, 6, or 7, please explain below (attach additional pages if necessary).
8. List any publications or presentations using these data since the last continuing review.
Revised 11/2012
Progress Report: Briefly describe the progress of your research (use additional sheet if necessary)
Assurance:
The undersigned assures that protocols involving human subjects described in this application are complete and
accurate, and are consistent with applicable protocols submitted to any external funding agencies. All protocol
activities will be performed in accordance with Chicago State University institutional guidelines and any
applicable State and Federal regulations. Research conducted by CSU researchers falls under the purview of the
University even when conducted elsewhere. Research at international sites must receive approval by the local
equivalent of the IRB. The CSU IRB requires documentation of this “local approval” before they can receive IRB
approval. No activities involving the use of human subjects can be initiated without prior review and approval by
the Chicago State University Institutional Review Board.
____________________________ _______________
Signature of Principal Investigator
Date
______________________________________________________________________________________________________________________________
FOR CSU IRB USE ONLY:
Approved by IRB Chair: _______________________ Date: _____________ Date Received: _______________
Revised 11/2012
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