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  • 1.  FDA Inspection/Survey with HE

    This message was posted by a user wishing to remain anonymous
    Posted 05-23-2023 14:38
    This message was posted by a user wishing to remain anonymous

    Has anyone gone through or experienced a FDA Inspection/Survey? How did you showcase Cayuse HE to the inspector, narrowed which studies were FDA studies, etc? Did you download everything on a flashdrive drive for them? Provided them a Cayuse account?



  • 2.  RE: FDA Inspection/Survey with HE

    TEAM CAYUSE
    Posted 05-26-2023 07:04

    Having asked my colleagues, the recommendations center around giving the auditor specifically what they ask for via printed materials or PDFs on a flash drive, rather than giving blanket access.  This keeps the focus solely on the requested information.  If you're using flags, flagged FDA studies can be identified via reporting.



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    MK Karafonda
    Sr Product Manager
    Cayuse
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  • 3.  RE: FDA Inspection/Survey with HE

    Posted 05-29-2023 20:33


    Can you explain how flags work? I would love to implement those, but have never seen them in Cayuse HE.



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    Daniel R. Kirienko, Ph.D.
    Preferred pronouns: he, him, his
    IRB Compliance Lead
    Office of Research Integrity
    Rice University| 350 Allen Center | 6100 Main Street, MS 16 | Houston, TX 77005
    Tel: 713.348.3586
    dk32@rice.edu
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  • 4.  RE: FDA Inspection/Survey with HE

    RISING STAR CONTRIBUTOR
    Posted 05-30-2023 13:43

    Hi, Daniel!

    For every HE form submitted for review, we use Flags to note important details about the project. For example, is it federally-funded? If so, are we the IRB of Record? Does the research include children or other defined "vulnerable" populations where additional regulations may be apply.  Flags have also been helpful to call out any projects that may be on "HOLD".  We are a SBER-only institution so identifying if research is taking place in schools, whether there's a "Waiver of Consent" and the level of risk i.e., Minimal or Greater than Minimal Risk.  Finally, we do research abroad so flagging a project as "International" helps to quickly realize when GDPR or other harmonization is required.  While some flags may never apply to our specific research, they are useful!

    Cheers,

    Dawn



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    Dawn Leusner
    IRB Manager
    Educational Testing Service
    Princeton, NJ 08541
    irb@ets.org
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  • 5.  RE: FDA Inspection/Survey with HE

    TEAM CAYUSE
    Posted 05-31-2023 09:58
    Edited by Simon Helton 06-01-2023 07:16

    Hi Daniel,

    Adding on to Dawn's comments just to let you know where Flags are and how to use them:
    https://support.cayuse.com/hc/en-us/articles/360012759533-Using-Flags
    In reports, you can choose Flags to add them in.

    Happy to chat about this anytime, just choose a convenient time here: https://calendly.com/matty-cayuse.

    Thanks,

    Matty



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    Matty Gilreath
    Senior Customer Success Manager
    Cayuse
    matty.gilreath@cayuse.com
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  • 6.  RE: FDA Inspection/Survey with HE

    Posted 06-01-2023 06:22

    Hi Matty,  

    Can you repost the link for flags? It seems to be broken.  Thanks!



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    Shannon Marquess
    Senior Research Compliance Coordinator
    University of Texas at San Antonio
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  • 7.  RE: FDA Inspection/Survey with HE

    TEAM CAYUSE
    Posted 06-01-2023 07:18

    The link should work now,@Shannon Marquess. Thanks for reporting!



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    Simon Helton
    He/him
    Community Manager
    Cayuse
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  • 8.  RE: FDA Inspection/Survey with HE

    CAYUSE CHAMPION
    Posted 06-08-2023 09:39
    Edited by Amanda Hong 06-08-2023 09:39

    When printing materials or saving as a PDF, is there a way to print submissions with the comments? As FDA will be needing to review correspondences.



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    Amanda Hong
    IRB Coordinator
    Mount Sinai Hospital
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