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  • 1.  FDA Inspection/Survey with HE

    This message was posted by a user wishing to remain anonymous
    Posted 16 days ago
    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

    Posted 13 days ago

    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.

    MK Karafonda
    Sr Product Manager

  • 3.  RE: FDA Inspection/Survey with HE

    Posted 10 days ago

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

    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

  • 4.  RE: FDA Inspection/Survey with HE

    Posted 9 days ago

    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!



    Dawn Leusner
    IRB Manager
    Educational Testing Service
    Princeton, NJ 08541

  • 5.  RE: FDA Inspection/Survey with HE

    Posted 8 days ago
    Edited by Simon Helton 7 days ago

    Hi Daniel,

    Adding on to Dawn's comments just to let you know where Flags are and how to use them:
    In reports, you can choose Flags to add them in.

    Happy to chat about this anytime, just choose a convenient time here:



    Matty Gilreath
    Senior Customer Success Manager

  • 6.  RE: FDA Inspection/Survey with HE

    Posted 7 days ago

    Hi Matty,  

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

    Shannon Marquess
    Senior Research Compliance Coordinator
    University of Texas at San Antonio

  • 7.  RE: FDA Inspection/Survey with HE

    Posted 7 days ago

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

    Simon Helton
    Community Manager

  • 8.  RE: FDA Inspection/Survey with HE

    Posted 15 hours ago
    Edited by Amanda Hong 15 hours ago

    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.

    Amanda Hong
    IRB Coordinator
    Mount Sinai Hospital