Closure Forms of Project Management - DOC by vqj18367

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									                                                                             Human Subject Protection Program
                                                                             Foundation Research Office
                                                                             Carle Foundation Hospital
Carle Foundation Hospital                                                    611 West Park Street
Institutional Review Board                                                   Broadway Research Center (BWRC)
FWA 00002292                                                                 Urbana, IL 61801
                                                                             Tel: 217-326-4509 Fax: 217-383-3993
                                                                             Email: irb@carle.com
Project Closure                                                              Web: www.carleconnect.com/irb.shtml
Version 1                                                       1/23/08


1. IDENTIFICATION
 IRB No:
 PI Last Name:                                               First Name:
 Project Title:
 Total Subjects who Signed the Consent Form:
 Where will study documents be retained, and under whose control?

2. STUDY CLOSURE IS REQUESTED
Check all reasons that apply for requesting Study Closure
      Research was not funded and/or was never initiated. Skip to part 8 below.
      The research was initiated but no subjects were enrolled in this study. There are no consent forms that
      require storage. Skip to part 8 below.
      Research has been completed. There will be no further data collection (including long term follow-up) or
      data analysis. All study documents have been secured.
      The PI is terminating this research prior to meeting approved goals/objectives. Explain:
      The sponsor is terminating the research. Explain:
      For completed sponsor supported clinical trials, study closure is for THIS site only:
      a. All subjects at your site have finished their final visits and any follow-up activities (such as phone calls,
          post-card contacts, or long-term follow up required by the protocol) are completed
      b. The sponsor or the sponsor representative has indicated the study is closed at your site (Attached is the
          sponsor close-out report dated:          )


3. UNANTICIPATED PROBLEMS INVOLVING RISK TO SUBJECT or OTHERS/ SERIOUS ADVERSE EVENTS
Were there any unanticipated problems or serious adverse events at your site that have not been previously
reported to the Carle IRB?
              No          Yes (If Yes, please attach the information)

4. COMPLAINTS
Were there any complaints about the study that have not been previously reported to the Carle IRB?
              No          Yes (If Yes, please attach the information)


5. FINANCIAL REPORT. Skip this section if the budget requirement was waived by the Carle Foundation
Research Office.

    Report the budgeted and total amount spent amounts during the life of the study:
     Budget Items                                      Budgeted                             Actually Spent
     PERSONNEL
     CONSULTANT/ CONTRACTUAL COSTS
     EQUIPMENT
     SUPPLIES
     TRAVEL
     PATIENT CARE COST


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      OTHER EXPENSES
      OVERHEAD/ INDIRECT
      TOTAL COSTS
      OTHER FUNDING


6. HIPAA DISCLOSURE TRACKING FORMS
    Have all HIPAA disclosure tracking forms been sent to Tricia Truscott at Carle Health Information Management
    (HIM)?
                   No          Yes        Not Applicable (no tracking forms were required for this study)
              If “no”, state when the tracking forms will be sent to HIM:

7. COMMENTS ABOUT THE STUDY



8. INVESTIGATOR ASSURANCE

    By submitting this Study Closure report, I certify that the information provided in the report is complete
    and correct and I agree to the following:

    1.      I am familiar with the Carle IRB Guidelines. I will adhere to the policies and procedures explained therein, as well as
            other policies and procedures established by the Carle IRB.

    2.      I am aware of the legal, regulatory, and ethical requirements to protect human subjects, including without limitation,
            protection of their personal privacy and the privacy of all information identifying and/or relating to them, and agree to
            comply with all such human subject protections.

    3.      I am aware of the applicable Carle policies and contract provisions associated with this research that require me and
            other individuals working on this project to keep all research related activities and information confidential. This
            information may only be shared with those who have a business reason to know it. I have informed all individuals who
            will work on this research project of the confidentiality requirements and will inform all new individuals of the same.

    4.      If I wish to make changes to the protocol or any other study documents, I will submit the changes to Carle IRB for
            approval prior to initiating the changes.

    5.      If any unanticipated problems involving human subjects occur, I will immediately notify the Human Subjects Protection
            Program at Carle at 217/383-4366.

    6.      If a research participant becomes incarcerated during the course of this study, I will immediately contact the Carle
            Human Subject Protection Program (HSPP). Approval will be obtained before the research can continue with that
            participant.

    7.      Presentations and publications resulting from this research shall acknowledge Carle appropriately.




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