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THE COMMITTEE ON HUMAN RESEARCH
UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES
GENERAL INSTRUCTIONS:
STUDY CLOSE-OUT REPORTING
(Posted:
January 2007, Revised May 2008)
 • Brief
Overview
• Reporting Form Use Requirement
• Where to Submit
• Additional Information
Brief Overview
The following table describes the CHR’s Study
Close-Out reporting requirements for various types of CHR-approved studies:
| Type of CHR Review |
When to Report |
Reporting Form |
| • |
Any study that received Full Committee Review at
some point in its approval. |
Report within 10-working-days of study close-out. |
Study
Close-Out Report required |
| • |
Any Expedited Review study that involved participant
contact |
| • |
Any Expedited Review study that never involved participant
contact |
No close-out report required. Study Close-Out Report
may be submitted when requested by sponsor. |
Study
Close-Out Report may be used, but not required |
| • |
Any Exempt study |
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:
- Local enrollment to the study is ongoing.
- Local
research-related interventions are ongoing.
- Local participant follow-up is ongoing.
- Data analysis or manuscript preparation that involves use or access
to individually identifiable information is ongoing.
- 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 the study may be closed.
- Your study has an external sponsor and you have not received permission from your study sponsor to close the study with the CHR.
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of Page Reporting
Form Use Requirement
To allow for substantive and meaningful review of research activities
at the close of a study, the investigator is required to submit the Study
Close-Out Report. This report updates the CHR on the conduct and outcomes
of the study, including any risks or problems that may have arisen since
the last study renewal and which may need to be disclosed to the study
participants or others.
Once a study is retired, no further submissions will be accepted by the CHR.
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Where to Submit
The HRPP accepts both hardcopy and electronic submissions of Study
Close-Out Reports.
For electronic submission
Study Close-Out Reports should be sent as
an email attachment to chr@ucsf.edu.
- The email subject line should state, “Study
Close-Out Report”.
- If the email is sent by study personnel, other than the Principal
Investigator, the PI should be cc’d on the email correspondence.
For hardcopy submission
Study Close-Out Reports should
be forwarded to
The Committee on Human Research
Box 0962
San
Francisco, CA
94143
They may also be dropped off at the CHR
office at Laurel Heights, Suite 315.
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Additional Information
For additional information, please
- call the CHR office at 476-1814
or
- send an email to chr@ucsf.edu
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