IRB Date Stamp—Office Use Only

							IRB Review - Office Use Only                  IRB Date Stamp - Office Use Only          IRB Accession Number


                                                                                        Office Use Only
                                                                                        IRB Project Number:


Northwestern University – Office for the Protection of Research Subjects
Project Termination/Closure Form (Also use for studies that were never initiated)
Instructions: Please refer to the Termination Guidelines on when to terminate a project.
http://www.northwestern.edu/research/OPRS/irb/handbook/guidance/termination guidelines.doc The Principal
Investigator must sign this termination report. If this project involves the Robert H. Lurie Cancer Center, please give a
copy of this report to the Clinical Research Director. If this project is conducted at RIC, please give a copy of this report
to the Research Office.
Forward this submission to OPRS, Rubloff, 7th Floor, 750 N. Lake Shore Drive, Chicago, IL 60611 or
Hogan, G100-6th Floor, 2205 Tech Drive, Evanston, IL 60208
Handwritten forms will not be accepted.
1. Date of Preparation:                                Date project is to be Terminated:
2. Principal Investigator Name:
Phone:                  Fax:                           E-Mail :
3. Submission Prepared By:
Phone                   Fax                            E-Mail:
4. Project Title:

5. Project Status:1
Determined by Investigator (Check appropriate box (s) describing project status)
    1.     Project is completed—No Further Contact with Human Subjects is planned: no subjects are, or will be, treated
    or followed; all data are gathered and analyzed; and there are no further sponsor reports or publications to submit to
    the IRB.
    2.     Project terminated by the investigator: Reason:
    3.     Project terminated by the sponsor. If by the sponsor, please attach documentation.
    4.     Project Never Initiated--No human subjects were recruited. Work will not be done at this time.
    5.     OPRS Initiated Closure
    6.     Other: Give Reason(s):

     6. Expiration Status
     6.1 Has IRB approval for this project expired?           No       Yes, If yes, please complete Section 6.2 below. If the
     study has not expired, please skip to Section 7.

     6.2 Was any research activity conducted after the project’s approval expired?   Yes, complete 1 and 2    No , go to Section 7
          1. Provide a description and summary of all research that has been conducted since the project expired,
             including subject recruitment, data collection, data analysis, and any other research-related activities.

          2. Was approval granted by the IRB Chair for the continuation of study procedures?
               Yes: Provide a copy of any paperwork (e.g., emails from the Chair) supporting this approval.
               No: Complete a Prompt Reporting Form as this is considered to constitute promptly reportable non-
                    compliance.



7. Project Summary: Attach a summary of your research findings written in lay language. Also include available
research analysis, reprints, overview of recent literature, and findings, good or bad, that should be disclosed to subjects. If
the project was never initiated explain why.

1
    All pending issues must be resolved prior to closure of the project.
Termination Report Form: VERSION 8/19/08                                                       Page 1 of 3
8. Enrolled Subjects:2
A. Total number of subjects/sample/charts approved for enrollment/to be studied in this project:
B. Total number of subjects/samples/charts enrolled/studied to date:
C. Have any subjects withdrawn from the study?:         No             Yes, Please explain on a separate sheet the reasons
for withdrawal—give the subject initials, date enrolled, reason for withdrawal, and any other additional information.
Reasons for withdrawal might include but not be limited to, lost to follow-up, moved from this area, serious adverse
events, and non-compliance on the part of the subject.
D. Is there a fully executed consent form in the study file for each subject reported in 6B?     Yes     No, Please explain
on a separate sheet.
E. Were more subjects enrolled than were IRB approved?            No      Yes, Please explain on a separate sheet.

9. Prompt Reporting Form/Death Summary:
9.1 Prompt Reports - Have there been any UPIRSOs or PRNCs reported to the IRB since the last continuing review or
initial review (whichever is more recent)?
    Yes – Complete the Prompt Reporting Form Summary for Continuing Review Form and submit with this report.
     No - All research-related problems and adverse events have occurred at the expected frequency and level of severity
as anticipated in the research protocol, the informed consent document, and/or any investigator brochure.

9.2 Deaths - Have there been any deaths of NU research subjects since the last continuing review or initial review
(whichever is most recent) which were not previously reported as UPIRSOs (i.e., anticipated deaths like death due to
disease progression)?
    Yes - Complete the Death Summary for Continuing Review Form review.
    No

10. External Audits: Has this project been audited by the FDA, DHHS, a sponsor or other external independent auditor?
        No
        Yes, provide a copy of all correspondence related to any audits and any applicable audit reports.


11. Investigator/Faculty Advisor Assurance:
Investigator’s Assurance:
I certify that the information provided in this application is complete and accurate.


_____________________________                   _______________________________                    _______________
Principal Investigator’s Name                   Principal Investigator’s Signature                     Date



12. VA Endorsement:


______________________________________________________________________________________
VA ACOS Research and Development Name and Signature (if applicable)            Date


            Please return completed form to: The Office for the Protection of Research Subjects (OPRS)
         E-Mail: irb@northwestern.edu               Website: http://www.northwestern.edu/research/OPRS


                                                     Chicago Campus

2
 Enrolled subjects are those who signed consent forms and are participating in (or completed) the study. (Participating =
e.g., filling out questionnaires, answering questions, taking drugs, having surgery, being called on the telephone, having
data collected.) Enrollment is a finite number usually dictated by the sponsor or by statistical methods.
Termination Report Form: VERSION 8/19/08                                                 Page 2 of 3
                             Rubloff, 7th Floor, 750 N. Lake Shore Drive, Chicago, IL 60611
                                    Telephone: (312) 503-9338 Fax: (312) 503-0555

                                                          Or

                                                 Evanston Campus
                              Hogan, G100-6th Floor, 2205 Tech Drive, Evanston, IL 60208
                                   Telephone: (847) 467-1723 Fax: (847) 467-3112




Termination Report Form: VERSION 8/19/08                                            Page 3 of 3