UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
COMMITTEE ON HUMAN RESEARCH
STUDY CLOSE-OUT REPORT
Please date form:
Street Address:
Committee on Human Research (CHR)
Office of Research
3333 California Street, Suite 315
University of California
San Francisco, CA 94118
Campus Mailbox:
CHR
Box 0962
Office Contact for questions:
Office: (415) 476-1814
Facsimile: (415) 502-1347 e-mail: chr@ucsf.edu
General Instructions - Study Close-Out Reporting is required for the following types of CHR-approved studies: 1) any study that received Full Committee Review, or 2) any study that received Expedited Review that involved participant contact. For complete study close-out information, please see General Instructions for Study Close-out Reporting .
Important Note: Do not close out a study if any of the following six conditions apply. Such studies must remain active and continue to receive ongoing CHR review and approval:
1.
Local enrollment to the study is ongoing.
2.
Local research-related interventions are ongoing.
3.
Local participant follow-up is ongoing.
4.
Data analysis or manuscript preparation that involves use or access to individually identifiable information is ongoing.
5.
Biological specimens containing individually identifiable information are being maintained in a repository that has been approved as part of this study or upon which analysis or research is ongoing. If specimens were transferred to a separate repository that has ongoing CHR approval, then they study may be closed.
6.
Your study has an external sponsor and you have not received permission from your study sponsor to close the study with the CHR.
A. General Information :
Principal Investigator:
Study Title:
CHR Approval Number: Expiration Date:
B. Study Status at Close-out:
[ ] Study was completed (please complete sections B-H)
[ ] Study was started but closed prior to completion (please indicate reason below and complete sections B-H)
[ ] Study was not started (please indicate reason below and skip sections C-G
[ ] Study is being transferred to another institution (indicate institution below in B.3):
1. Reason study was not started or was closed prior to completion:
2. Did this study involve the collection, storage, or use of any human biological specimens?
If yes, please explain what will happen with the specimens at the close of this study.
[ ] Yes [ ] No
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UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
COMMITTEE ON HUMAN RESEARCH
STUDY CLOSE-OUT REPORT
Please date form:
3. Which institution is this study being transferred to? What parts of the study are being transferred? Be sure to work with the Office of Sponsored Projects and your Department to make sure everything you need to transfer the study has been or will be completed.
C. Summary of Study Results: Please summarize the results of this research project, even if only for the study cohort enrolled locally.
Have there been any presentations or publications resulting from this study since last study renewal? If yes, please describe and cite references.
[ ] Yes [ ] No
D. Recruitment and Enrollment: Was there any participant contact since the date of last renewal?
[ ] No (skip sections E-G)
[ ] Yes (complete remaining sections, E-H)
E. Reporting and Summary of 10-day Reportable Adverse Events and other Safety Information:
1.
Are you submitting any new or missed 10-day AE reporting forms now? [ ] Yes [ ] No
2.
Are you submitting any new or missed DSMB or other multi-center oversight reports now that were not submitted previously?
[ ] Yes [ ] No
3.
Were there any other unexpected safety developments that the CHR should know about? [ ] Yes [ ] No
If yes to question #3 please explain :
F. Reporting and Summary of Protocol Violations and/or Protocol Incidents :
1.
Are you submitting any new or missed 10-day Violation/Incident reporting forms now?
2.
Were there any other unexpected developments in study conduct that the CHR should know about (e.g., problems with study activities or participant complaints)?
If yes to question #2 please explain:
[ ] Yes [ ] No
[ ] Yes [ ] No
G. Study Activity after CHR-Approval Expiration: Please answer the following questions if the CHR study approval has expired.
If the CHR-approval for this study has expired, did any research-related activity(ies) occur during the lapse in approval?
[ ] Yes [ ] No
October 2008 Page 2 of 3

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
COMMITTEE ON HUMAN RESEARCH
STUDY CLOSE-OUT REPORT
Please date form:
If yes , please answer the following four questions:
1. Were any participants enrolled during the period of protocol lapse?
2. Did any other research-related activity(ies) continue during the period of protocol lapse?
3. How did the approval lapse occur?
4. What will be done do to prevent this from happening in the future for other studies?
[ ] Yes [ ] No
[ ] Yes [ ] No
If yes to either questions #1 or 2 , please describe all research-related activities that continued, including number of participants involved and any adverse events, violations or incidents that occurred during the period of protocol lapse:
H. Principal Investigator's Certification:
I certify that all study activity involving participant contact, or use or access to individually identifiable information has ceased and the information provided in this report is complete and correct.
Principal Investigator's Signature Date
Principal investigator’s signature or typed name indicates her/his awareness of information above.
October 2008 Page 3 of 3