Risk Management

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IRB - 45 CFR 46.118 determinations

  • 1.  IRB - 45 CFR 46.118 determinations

    CAYUSE CHAMPION
    Posted 02-19-2021 08:09
    Hi,

    Has anyone used Cayuse to manage 118 determinations for "Applications and proposals lacking definite plans for involvement of human subjects" ?

    Do you have a letter template and issue it after a PI has started an initial application, or do you manage them outside of Cayuse?  Or do you do something else?

    Thanks,

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    Matt Zembrzuski
    Research Compliance Manager
    American University
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  • 2.  RE: IRB - 45 CFR 46.118 determinations

    TEAM CAYUSE
    Posted 03-03-2021 16:52
    Hi Matt, thank you for your inquiry.
    Just wanted to point out that 118 determinations has been suggested as an enhancement in the Product Idea section. You can find it here. Feel free to vote on it and/or add any comments. Our product team will review the ideas early April.
    If you'd like me to connect you with customers who have found work-around for now, please let me know. thanks

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    Colette Akiki
    Sr. Customer Advocacy Manager
    Cayuse
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  • 3.  RE: IRB - 45 CFR 46.118 determinations

    CAYUSE CHAMPION
    Posted 03-04-2021 09:55
    Oh good,  I chimed in there as well.  Thanks for the tip, @Colette Akiki!


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    Matt Zembrzuski
    Research Compliance Manager
    American University
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  • 4.  RE: IRB - 45 CFR 46.118 determinations

    TEAM CAYUSE
    Posted 03-04-2021 13:02
    Perfect, thanks for your contribution Matt.

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    Colette Akiki
    Sr. Customer Advocacy Manager
    Cayuse
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