Cover Sheet - Continuing Review or Other
Date: / IR File#: / Protocol #:
Fred Hutch Principal
Investigator: / Mailstop: / Phone:
Fred Hutch Contact
Person: / Mailstop: / Phone:
Study
Title:
1.Which organization is Fred Hutch relying on to provide IRB review (e.g. UW, Benaroya, etc.)?
2. Specify type of submission:
Continuing Review
Study Closure Closure Date: (Please include closure documentation.)
Other:
3.Has there been a change in either the PI at Fred Hutch or at the Institution Fred Hutch is relying on to provide IRB review?
No
Yes please explain:4.What is the IRB identification number issued by the IRB of record (e.g. UW IRB# 30124)?
5.What is the new IRB approval period issued by the IRB of record? Attach a copy of the IRB approval letter reflecting the new approval period and a copy of the entire continuing review or status report.
6.Have there been any changes in the Conflict of Interest status for anyone on the study team?
No
Yes please describe the change in conflict:
7.Have there been any changes to the protocol in the last year?
No
Yes Attach a copy of the most recent, IRB-approved protocol.
8.Have there been any changes to the consent form(s) in the last year?
No
Yes Attach a copy of the most recent, IRB-approved consent form(s).
9.Have any other new or revised study materials been approved by the IRB in the last year (e.g. advertising, questionnaires, etc.)?
No
Yes Attach a copy of the most recent, IRB-approved study material(s).
INVESTIGATOR STATEMENT AND SIGNATURE
As PRINCIPAL INVESTIGATOR, I acknowledge that all of the information provided in this submission is true to the best of my knowledge;that I am responsible for reporting any emergent problems, unanticipated problems involving risks to subjects or others, serious or continuing noncompliance, or proposed procedural modifications to the IRB of record and that no modifications will be put into effect without prior approval by the reviewing IRB approval except where necessary to eliminate apparent immediate hazards. I will renew this application with the reviewing IRB at the frequency specified in the IRB approval; that the research project is being conducted in compliance with the reviewing IRB's understanding and recommendations as well as the policies of the Fred Hutch and University of Washington (as applicable); that each individual listed in the Conflict of Interest section has complied with the Fred Hutch requirement to submit an “Annual Summary of Outside Activities and Interests”; and that this research activity will not be initiated until final IRB approval from the reviewing IRB and all Fred Hutch institutional approvals have been obtained.
Investigator Name / Signature / Date0321IRBform_CRRExtIRBCoverSheet / Version 2.01 / 11-13-2017 / Page 1 of 2