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USMA Human Research Protections Program
Protocol Closure Report
A study is complete when the study is closed to further enrollment of subjects and all subjects have
completed all research-related interventions and follow up; the research team has completed all of the
specific aims, including data collection and analyses identified in the protocol; and the PI has submitted
the final report.
Completion means the end of subject recruitment and all subject interactions, and completion of any
planned experiments, analyses, or manipulations of research materials. Studies that have not reached
that stage of completion may not be closed.
Retention of research materials *or* planned, contemplated, or potential uses of them not already
specified and approved in the current project must be reviewed and approved as a new protocol.
Section A: Protocol Demographics
Date of Closure Request: _____________________________________________________
Date of Protocol Expiration: ___________________________________________________
Protocol Title:
___________________________________________________________________________
___________________________________________________________________________
Protocol N u m b e r : __________________________________________________________
Principal Investigator: ________________________________________________________
Was the Project successfully completed? Yes___
No___
Completion of at least one study objective or a published abstract.
Section B : Request Protocol Closure Action
1. A closure of the above referenced study is requested, for the following reason(s):
All study related activities are completed, including data analysis
All data has been collected, de-identified, close-out procedures have b e en
com pl et ed
Study was never initiated
Study closed at sponsor's request
Study closed at PI's request without completing data collection
PI moving to another Institution (No other PI can be identified)
2. Describe the rationale for closure if anything other than study completion.
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_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Section C: Summary of Study Management
1. Progress
No subjects enrolled
Database protocol
Results supported the hypotheses
Results did not support the hypothesis
Results are not conclusive
2. Complaints
Did any research subjects complain about any aspects of the study during its conduct?
No
Yes ( If not previously reported, provide the number of complaint(s) and briefly
describe.)
3. Deviations
Were there any protocol deviations that occurred since the start of this study?
No
Yes (If not previously reported, provide a final Protocol Deviation Log.)
4. Categorization of problems/events over the lifetime of the study
Adverse Events (AEs)
No
Yes (Explain in the summary)
Serious Adverse Events (SAEs)
No
Yes
(Explain in the summary)
Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSOs)
No
Yes (Explain in the summary)
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Section D: Summary of Presentations and Publications
Date of Presentation
Title, Name of Conference, and Location
Publication Title and Citation
Future Scholarly Activity Based Upon Research
________________________________________________________________________________
________________________________________________________________________________
_____________________________________________________________________________
Section E: Pl Responsibilities After Closure
As the Principal Investigator, I understand the following:
Closure means that the KACH IRB approval has ended.
Consent documents are stored for 3 years.
Continued analysis of permanently de-identified data by the researcher is authorized.
All funding sources must be notified and IID (x2764) is notified of funding changes, including
concluding or discontinuation of funds.
Section F: Privacy/Confidentiality Final Measures
What is the disposition of the data?
Data completely de-identified
Data destroyed
D a t a r endered free of all personally identifiable information?
None of the above (Describe the plans for data management in the summary.)
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Section G: Protocol Closure Summary (Separate Sheet)
The Protocol Closure Summary must include a summary of what was learned, and to what extent the
project met its goals, as well as:
The date of closure; reason for closure; number of subjects accrued; summary of AEs and any
unanticipated problems involving risks to others; summary of any withdrawal of subjects since the last
IRB review; summary of all protocol amendments implemented during the study period; summary of
relevant research literature, interim findings, and amendments or modifications to the research since
the last IRB review; any relevant multi-center trial reports; any other relevant information, especially
newly discovered risks; and a copy of the last KACH IRB stamped informed consent document and
most recent revision of the study protocol.
Be sure to address plans for retention, disposal, or future use of any research materials generated in the
course of the study.
PRINCIPAL INVESTIGATOR ACKNOWLEDGEMENT
_______________________________________
Signature of the Principal Investigator
_______________________________________
Signature of IRB Chair
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Date
____________________
Date
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