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  • 1.  Modification Submission Examples

    Posted 08-31-2022 14:35

    Hi! I am the administrator for a small healthcare college IRB that mainly reviews student projects. I am working on some submission templates that have not gotten much attention, and our modification submission is quite sad. Would anyone be willing to share an example of a modification submission you use? Even screenshots are helpful. Our current template asks one question and doesn't really provide any guidance. I need some creative motivation, I think. Thanks so much!

     

    Brenda C. Barnes, Ph.D., MLS(ASCP)SBB she/her/hers
    Director, Medical Laboratory Science Program
    Director, Ed.D. Health Professions Education Program
    Professor
    Administrator, Allen College Institutional Review Board

    Allen College – UnityPoint Health
    1825 Logan Ave.
    Waterloo, IA  50703
    (319) 226-2082 office
    (319) 226-2508 fax

     

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  • 2.  RE: Modification Submission Examples

    STAR CONTRIBUTOR
    Posted 09-01-2022 05:37
    Brenda,

    We just updated ours to include a bit more information about how Cayuse creates a copy of the last approved, etc.  We also have questions about making changes vs providing post-approval documents that couldn't be obtained until IRB approval.  Maybe it will help.

    I've attached the annotated copy we make available as a reference to investigators as well as the eemplate file if you want to play with it in your training environment. (We are on the Platform.)

    Regards,
    Darcy

    ------------------------------
    Darcy Hammar
    Director, HRPP
    Rocky Mountain University of Health Professions
    ------------------------------

    Original Message


  • 3.  RE: Modification Submission Examples

    Posted 09-01-2022 06:50
      |   view attached
    Brenda,

    Attached is the modification that we use. We ask about who initiated the amendment (PI vs Sponsor), what the changes are, justification for needing to make them, any changes to risk determination, and if the change is in response to an incident.

    ------------------------------
    Whitney McAllister
    Director, Human Research Protection Program
    Wright State University
    ------------------------------

    Attachment(s)

    etemplate
    Modification Submission_Revision1.etemplate   7 KB 1 version
    Original Message


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