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    9.1 Study Completion Termination Form

    Uploaded by

    Joniel Getano
    This document is a study completion/termination form submitted to an institutional review board. It provides information about a research study that has been completed or terminated. Key details include: the principal investigator and study title; whether the study was completed or terminated and possible reasons why; the dates and participant numbers at commencement and completion; any adverse events; and a brief summary of results. The form requires signatures from the principal researcher, department head, and institutional review board staff. The review board may request additional actions or information before officially closing the study.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    9.1 Study Completion Termination Form

    Uploaded by

    Joniel Getano
    180 views2 pages
    This document is a study completion/termination form submitted to an institutional review board. It provides information about a research study that has been completed or terminated. Key details include: the principal investigator and study title; whether the study was completed or terminated and possible reasons why; the dates and participant numbers at commencement and completion; any adverse events; and a brief summary of results. The form requires signatures from the principal researcher, department head, and institutional review board staff. The review board may request additional actions or information before officially closing the study.

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    © © All Rights Reserved

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    PDF, TXT or read online from Scribd

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    This document is a study completion/termination form submitted to an institutional review board. It provides information about a research study that has been completed or terminated. Key details include: the principal investigator and study title; whether the study was completed or terminated and possible reasons why; the dates and participant numbers at commencement and completion; any adverse events; and a brief summary of results. The form requires signatures from the principal researcher, department head, and institutional review board staff. The review board may request additional actions or information before officially closing the study.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    180 views2 pages

    9.1 Study Completion Termination Form

    Uploaded by

    Joniel Getano
    This document is a study completion/termination form submitted to an institutional review board. It provides information about a research study that has been completed or terminated. Key details include: the principal investigator and study title; whether the study was completed or terminated and possible reasons why; the dates and participant numbers at commencement and completion; any adverse events; and a brief summary of results. The form requires signatures from the principal researcher, department head, and institutional review board staff. The review board may request additional actions or information before officially closing the study.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    Study Completion/Termination Form Reference

     Number  
    as  assigned  by  the  OLFU-­‐IERC

    Our Lady of Fatima University


    Institutional Ethics Review Committee

    Principal Investigator
    Last Name First Name Middle Name
    College/Department

    __________________________________________________________________________________________________
    Research Title
    __________________________________________________________________________________________________

    1. Indicate the status of protocol. ☐ Completed ☐ Terminated


    2. Check one or more reasons for protocol completion/termination, and provide explanations if necessary.
    ☐ Goals were reached Explanation:
    ☐ Funding was not received _______________________________________________________________
    ☐ Investigators have lost interest _______________________________________________________________
    ☐ Goals were not reached _______________________________________________________________
    ☐ Protocol was closed due to serious deviation/violation _______________________________________________________________
    ☐ Other reasons (﴾please explain)﴿
    _______________________________________________________________

    3. Date of study completion/


    termination: (﴾mm/dd/yyyy)﴿
    4. Total number of participants
    employed at commencement:
    5. Total number of participants at
    completion of study:
    6. Did any serious adverse events occur? ☐ Yes ☐ No If yes, how many?
    a. Were these reported to OLFU-‐IERC? ☐ Yes ☐ No If no, complete a Protocol Deviation/Violation Form.
    7. Provide a brief description of the results.
    _____________________________________________________________________________________________________________________________
    _____________________________________________________________________________________________________________________________
    _____________________________________________________________________________________________________________________________
    8. Have there or will there be any publications using the results? ☐ Yes ☐ No ☐ Planned but no date
    If yes, attach a copy of the publication/s with this form.

    I certify that as of the date below, the Institutional Ethics Review Committee should officially close the protocol.

    SUBMITTED BY NOTED BY RECEIVED BY DATE RECEIVED


    For OLFU-‐IERC use only

    _____________________________ _____________________________ _____________________________


    Signature over printed name Signature over printed name Signature over printed name
    Principal Researcher Unit/Department Head OLFU-‐IERC staff

    Our  Lady  of  Fatima  University    


      Institutional  Ethics  Review  Committee  
    Form 9.1 Page 1 of 2
     
    TYPE OF REVIEW ACTIONS TO BE TAKEN:

    ☐ Full ☐ Please accomplish the following:


    ☐ Expedited ☐ Promptly inform the subjects of the termination/suspension of the study and provide
    assurance to them.
    ETHICS CHAIR ☐ Summarize subject status.
    ☐ Remind co-‐investigators of their continuing study obligations.
    ☐ Outline the results of the study or provide a copy of the study report that includes the
    _____________________________ justification of the premature ending of the trial.
    Signature over printed name
    ☐ Submit needed information.
    Ethics Chair
    ☐ Accomplish needed actions.
    REVIEWED BY
    ☐ Study completion approved.

    _____________________________ Additional actions and recommendations:


    Signature over printed name ________________________________________________________________________________________________
    Lead Reviewer
    ________________________________________________________________________________________________
    DATE REVIEWED ________________________________________________________________________________________________
    ________________________________________________________________________________________________
    ________________________________________________________________________________________________

    Our  Lady  of  Fatima  University    


      Institutional  Ethics  Review  Committee  
    Form 9.1 Page 2 of 2
     

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