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Vanderbilt University Institutional Review Board

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					IRB #:
Date of IRB Expiration:
Principal Investigator:
Study Title:
                                         Vanderbilt University Institutional Review Board
                                  Behavioral and Social Sciences
                        Application for Continuing Review or Study Closure

STATUS OF THE RESEARCH
Check the ONE choice that best describes the current state of this research study:
       No participants have been enrolled to date.
          Recruitment and/or enrollment of new participants or review of records continue.
          Study is no longer enrolling, but participants are still involved in research-related activities.
         Study is no longer enrolling and participants have completed research-related activities. The study remains
         active only for long-term follow-up. IRB fees do not apply.
          Study enrollment is permanently closed, participants have completed all research-related activities, and
         long-term follow-up has been completed. The remaining research activities are limited only to data analysis
         that may require contact with information to which you would not normally have access (e.g., medical
         records, academic records, etc.). IRB fees do not apply.
         Close the study. Enrollment and follow-up are complete and no further contact with participants or
         information to which you would not normally have access is anticipated. Please provide/attach a final
         study report, including final enrollment numbers, the reason for closure, and any related
         publications. IRB fees do not apply.

1. VU ENROLLMENT NUMBERS

         A.            Maximum number of participants previously approved by the VU IRB to be consented by this PI for
              the life of the study. *Note: The totals in columns 3 and 5 of the table below should not exceed this number.

         B.   Please provide ALL information requested in the table below. If the study has been active for only one year,
              columns five and six DO NOT apply.
              *Note: These numbers should reflect participants enrolled by the VU Principal Investigator and/or additional
              personnel involved in the study.

                1                     2                  3                     4                        5               6
        Category/Group        Number Directly         Number               Number of                * Number        * Number of
         (e.g., parents,          Solicited          Consented            Withdrawals               Consented        Withdrawals
       children, teachers,     (applies only to      Within the            Within the            Since Beginning   Since Beginning
             adults)           survey studies)        Last IRB              Last IRB                the Study         the Study
                                                   Approval Period       Approval Period
                                        N/A

                                        N/A


                                        N/A


                                        N/A

    Insert additional rows if needed.


           TOTALS
       Enter totals from
        columns above                   N/A




Behavioral and Social Sciences Application for Continuing Review or Study Closure (Form #1129)                             1 of 3
Form Revision Date: February 21, 2011
Form Replaces Version Dated: November 22, 2010
IRB #:
Date of IRB Expiration:
Principal Investigator:
Study Title:

2. SUMMARY OF PROGRESS WITHIN THE LAST IRB APPROVAL PERIOD
   Please answer the following questions. If any questions do not apply to your study, please check “No.”

    A.      Yes     No     i. Within the last approval period, was the study open to enrollment?
                              If “Yes”, answer 2.A.ii. If “No”, continue to 2.B.

                           ii.       Yes No Within the last approval period, were participants enrolled in the study?
                                 If “No”, provide a summary describing the reason(s) for no enrollment.

    B.      Yes     No     Within the last approval period, have there been any participants who withdrew (including PI
                           initiated withdrawals), dropped out, or were lost to follow-up?
                           If “Yes”, attach a narrative summary describing the reasons for the withdrawals.

    C.      Yes     No     Within the last approval period, have you had any problems recruiting participants?
                           If “Yes”, attach a narrative summary describing the problems recruiting subjects.

    D.      Yes     No     Within the last approval period, have there been any participant complaints regarding the
                           research?
                           If “Yes”, attach a narrative summary describing the complaints.

    E.      Yes     No     Within the last approval period, has any literature relevant to the research been published that
                           might change the understanding of the risks and/or benefits of the study?
                           If “Yes”, attach copies of the publications and a narrative summary.

    F.      Yes     No     Within the last approval period, have there been any interim findings, including manuscripts,
                           abstracts, and publications?
                           If “Yes”, attach copies of publications and/or citations and a narrative summary.

    G.      Yes     No     Within the last approval period, have there been any progress reports on the research, such
                           as those submitted to funding agencies?
                           If “Yes”, attach copies of the progress reports and a narrative summary.

    H.      Yes      No    Within the last approval period, have there been any progress reports from participating non-
                           VU sites?
                           If “Yes”, attach copies of the reports and a narrative summary.

    I.      Yes     No     Since the most recent IRB continuing review approval* have there been any other information
                           relevant to this research discovered, especially information about the risks and benefits
                           associated with the research that may affect the participant’s willingness to continue
                           participation?
                           If “Yes”, attach copies of the information and a narrative summary.

    J.      Yes     No     Within the last approval period, have any unanticipated problems involving risks to participants or
                           others occurred at VU and/or non-VU sites?
                           If “Yes”, attach a narrative summary describing the unanticipated problems involving risks to
                           participants or others, including the number of events.

    K.      Yes     No     Within the last approval period, have all unanticipated problems involving risk to participants or
                           others that require prompt reporting to the IRB been reported?
                           If “No”, provide the IRB with the required reports within 5 business days.

    L.      Yes     No       Within the last approval period, has the adverse event profile experienced by participants
                             differed from that expected? (“Adverse event” means any untoward or undesired outcome of
                             the research, including both serious and non-serious events, expected and unexpected events,
                             and events related and unrelated to the research.)
Behavioral and Social Sciences Application for Continuing Review or Study Closure (Form #1129)                  2 of 3
Form Revision Date: February 21, 2011
Form Replaces Version Dated: November 22, 2010
IRB #:
Date of IRB Expiration:
Principal Investigator:
Study Title:
                                If “Yes”, attach a narrative summary describing how the adverse event profile differs from
                                expected.

     M.         Yes      No     Is an Independent Safety Monitor or Data Safety Monitoring Board (DSMB) assigned to
                                periodically review data from this study for risks to participants?
                                If “Yes”, how often does the monitor or board perform a review?

                                    Yes No Within the last approval period, has the Independent Safety Monitor or Data
                                Safety Monitoring Board (DSMB) provided any reports of its reviews?
                                If “Yes”, attach the report(s) and a narrative summary.

3.   INFORMED CONSENT DOCUMENT INFORMATION
                Yes      No     Did the IRB require use of a written informed consent document for this study?
           If “Yes”, submit a copy of the currently approved informed consent document AND a clean copy of the
           identical informed consent document for approval and date stamping for use during the next approval period.
           (Note: If the study is closed to enrollment, do not attach consent forms).



4. BUDGETARY AUTHORIZATION

          Yes         No   Is this continuing review for an Industry-Supported study? (If so, it is expected that the sponsor
                           will pay the IRB continuing review fee of $750.) If “No,” skip to item 5.

     For VU/VUMC:
        Please charge my account as follows:
         Center Number:                 Account Number:

     For VSRH, IEI or other non-Vanderbilt sites, payment is required as specified in the signed MOU:
        I have attached a check payable to the “VU IRB” in the amount of $750.

          Check requested—I will forward to the IRB when received.


5. INVESTIGATOR’S CONFLICT OF INTEREST (COI) STATEMENT

          Yes         No Has a new conflict of interest developed for the Principal Investigator or key study personnel?
                         Assessment should include anyone listed as Principal Investigator or other research personnel on
                         the IRB application. Please note that the thresholds of ownership described below apply to the
                         aggregate ownership of an individual investigator, his/her spouse, domestic partner and
                         dependent children (e.g., if an investigator, his/her spouse, domestic partner and dependent
                         children own together $10,000 or 5% worth of equities in the sponsor, it should be reported
                         below). Do not consider the combined ownership of all investigators.

                           If “Yes”, has this COI been reviewed by the VU Conflict of Interest Committee?     Yes      No




Behavioral and Social Sciences Application for Continuing Review or Study Closure (Form #1129)                      3 of 3
Form Revision Date: February 21, 2011
Form Replaces Version Dated: November 22, 2010

				
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