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  • 1.  Legacy Study - Human Ethics

    CAYUSE CHAMPION
    Posted 10-27-2022 06:41
    Hello All,
    New to Human Ethics. Was wondering if someone would be open to sharing how they templated their legacy study submission? Believe should be a short version of an initial submission, but don't want any backlash from our PIs/Coordinators for redoing an application again. Be greatly appreciated.

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    Amanda Hong
    IRB Coordinator
    Mount Sinai Hospital
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  • 2.  RE: Legacy Study - Human Ethics

    STAR CONTRIBUTOR
    Posted 10-27-2022 11:34
      |   view attached
    Amanda,

    We probably did too little, but we focused on what items were most likely to be Modified changed before closure.  (We are 95% student, one-and-done projects.)

    We had Sections for
    • Study Personnel
    • Recruitment
    • Subjects
    • Informed Consent
    • Design and Methods
    • Legacy Documents

    The legacy documents were in a Google drive as we had come from a document management system.  We only had about 60 legacy studies to move and I was given internal support to download all the documents from the old system.  I think it took my "temp" a day to create folders, download, organize, etc.

    I have attached the template efile.  I'm also happy to meet if that would  be helpful.

    Regards,
    Darcy

    ------------------------------
    Darcy Hammar
    Director, HRPP
    Rocky Mountain University of Health Professions
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    Attachment(s)

    etemplate
    Legacy Submission v2.0_Revision4.etemplate   14 KB 1 version
    Original Message


  • 3.  RE: Legacy Study - Human Ethics

    CAYUSE CHAMPION
    Posted 10-28-2022 05:49

    Hi Darcy,

     

    Appreciate the feedback. Was thinking the same with Sections. What does it look like when they submit a Modification?

    Thanks!

     

    Best,

    Amanda H.

     




    Original Message


  • 4.  RE: Legacy Study - Human Ethics

    STAR CONTRIBUTOR
    Posted 10-31-2022 11:19
    Any Modification copies the previous Initial Submission.

    This drove how we decided what Sections/fields our Legacy Submission should have.  We based the legacy on what items were most likely to be changed before closure - subject numbers, inclusion/exclusion and recruitment are where we see the most changes for student projects, but we also wanted a methods summary in the Legacy Submission for reference/context when the typical changes were asked.

    I hope this makes sense and I have answered your question.

    Regards,
    Darcy

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


  • 5.  RE: Legacy Study - Human Ethics

    Posted 10-28-2022 05:31
    Hi Amanda,
    We also took a minimalist approach. We created attachment fields and uploaded each component from the original protocol separately. The attachment fields were:
    - Initial Application/Protocol
    - Consent Forms
    - Assent Forms
    - Study Instruments
    - Recruitment Materials
    - Debriefing Documents
    -Training Certificates
    - Other (this is where we uploaded award letters, CR, modifications, and correspondence)

    IRB admin and staff worked on this. We had about 100 legacy files to upload. Naming conventions were key.

    Best of luck! It is so worth it.

    ------------------------------
    Cara Martin-Tetreault
    Director of Sponsored Research/Compliance
    Bowdoin College
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    Original Message


  • 6.  RE: Legacy Study - Human Ethics

    CAYUSE CHAMPION
    Posted 10-31-2022 07:09
    Hi Amanda,

    We just had one form for the legacy files. Prior to implementing Cayuse, we had our researchers to save pdf files of their applications from the previous system. So our legacy files have one page and we have them to upload a pdf of the entire application which included all documents, their CITI training completion reports, and their previous letter (approval, exemption, Non-HS) from the IRB.

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    Alicia Scott
    IRB Director
    The Chicago School of Professional Psychology
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    Original Message


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