YALE UNIVERSITY
HUMAN INVESTIGATION COMMITTEE/HUMAN SUBJECT COMMITTEE
Request to Close a Research Study
100 FR 5C (2015-1)
Use this form when requesting to close a research study operating under the purview of the Human Investigation
Committee (HIC) or Human Subject Committee (HSC).
For studies reviewed by HIC, email this form to hic.submissions@yale.edu
For studies reviewed by HSC, email this form to human.subjects@yale.edu
Please note that a protocol cannot be closed if:
 Subjects will still be enrolled
 Subjects are still receiving study interventions
 Subjects are in long term follow up
 Data analysis of identifiable data is ongoing
 The sponsor has not provided a closure letter (if applicable).
If any of the activities above are taking place, a Request to Reapprove a Research Study
form available on the HRPP website must be submitted to the IRB for approval to ensure continuing compliance with
federal regulation and University policies.
Additionally, any protocol that includes a secondary aim or component that involves the banking of identifiable
biological specimens or data for a time period exceeding the duration of the primary protocol cannot be closed. The
protocol must remain open for as long as identifiable biological samples or data are being retained for future research
purposes by Yale researchers. Alternatively, investigators may create a new protocol that focuses on the banking and
secondary uses of biological samples or data. See the repository application at http://www.yale.edu/hrpp/formstemplates/biomedical.html.
HIC/HSC Protocol Number: Click here to enter text.
Title of Research Project: Click here to enter text.
Investigator Name Click here to enter text.
Campus Address:Click here to enter text.
Campus Phone:Click here to enter text.
E-mail:
Click here to enter text.
Faculty Advisor:Click here to enter text.
Protocol Correspondent Name & Address (if different than PI): Click here to enter text.
Campus Phone: Click here to enter text.
E-mail:
Click here to enter text.
1.
Reason for Request to Close/Terminate
a. ☐ Project never started
b. ☐ Completed per protocol/study aims
c. ☐ Study terminated by sponsor for reasons listed in attachment
d. ☐ Other (Describe): Click here to enter text.
2.
Have all interventions been completed?
Yes ☐ No ☐ N/A☐
3.
Is all follow-up complete?
Yes ☐ No ☐ N/A ☐
4.
Is the analysis of all identifiable data complete?
Yes ☐ No ☐
5.
Yes ☐ N/A ☐
Will identifiable data be destroyed/maintained according to the protocol plan?
Yes☐ No ☐ N/A☐
5a) Will de-identified data be used for any other purpose?
Yes ☐ No ☐ N/A ☐
Please note, additional use of the data may require a new study, please contact the IRB to discuss.
6. Submit any Data Safety Monitoring Board/Committee reports that were not previously reported to the IRB.
Attached ☐ N/A ☐
7. Have any publications been submitted as a result of this study?
Yes ☐ No ☐
If yes, give citation(s):
8. Is this an industry sponsored study? If so, sponsor closure letter must be attached.
Yes ☐ No ☐
9. Are there any outstanding requests from the IRB to be resolved before closing the study?
Yes ☐ No ☐
10. Are there any audits/study assessments scheduled or pending (e.g. HRPP Compliance, University Audit,
YCCI Office of Quality Assurance and Training, Office of Research Compliance and Education, etc.)?
Yes ☐ No ☐
If Yes, explain: Click here to enter text.
11. Have all FDA requirements been met (if applicable)?
Yes ☐ No ☐ N/A ☐
REMINDER: If the PI is the holder of the IND/IDE, ensure that all FDA documents are in order.
IRB Staff Initials Click here to enter text.
Date: Click here to enter text.
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