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  • 1.  Reporting non-compliance and Adverse Events

    CAYUSE CHAMPION
    Posted 08-13-2021 14:34
    Does anyone have any good (or even not so good) templates for non-compliance reports and/or for adverse event reports to share?

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    Angela Bain, CIP, CIM
    Director, IRB Office
    Kennesaw State University
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  • 2.  RE: Reporting non-compliance and Adverse Events

    CAYUSE CHAMPION
    Posted 08-17-2021 09:53
    Hi Angela,
    We are a Social/Behavioral IRB so our incident report template will be different than a clinical/medical IRB. Glad to share if you are still interested. Just message me your email address.
    Hila

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    Hila Berger
    Director Research Compliance & Regulatory Programs
    Montclair State University
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  • 3.  RE: Reporting non-compliance and Adverse Events

    CAYUSE CHAMPION
    Posted 08-17-2021 10:03
    Since this happens so infrequently and because we are very small, we actually have the individual report directly to the Chair when an event happens and the person would then do an interview with the Chair to get the details on the situation.

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    Kris A. Monahan, Ph.D.
    Director Sponsored Projects and Research Compliance
    Providence College
    Providence, RI
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  • 4.  RE: Reporting non-compliance and Adverse Events

    TEAM CAYUSE
    Posted 08-17-2021 10:11

    This is a great topic, so I'm going to tag some folks who might want to follow along or contribute: @Darcy Hammar, @Carey Nadeau, @Corey Brooks, @Annette King, @Amany S. Dahir, @Becky Welch, @April Gravitt, @Domenica Pappas, @Sherrie Hixon, @Sharla Miles, @Nina Yolen, @Audrey Wineglass Foster, @Amy Krenzer, @Michael Leary, @Maureen Wawsczyk, @Beverly Kemp, @Kathleen Furr, @Kareem Gad, @Michael Spires, @Andrea Buford, @Louise Griffin, @Shannon Augustine, @Dawn Leusner, @Marnie Shaffer, @Steve Sutcliffe, @Wun Chiou, @Jennie Kulczyk, @Dana Lawrence, @Weldon George, @Melissa Beck, @Rachel Agner, @Melissa McGee, @Jenn Dier, @Jessica Prim

    ​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​

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    Simon Helton
    He/him
    Community Manager
    Cayuse
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  • 5.  RE: Reporting non-compliance and Adverse Events

    CAYUSE CHAMPION
    Posted 08-17-2021 10:20
    Hi Angela,

    This is a really good question to see what others are doing at their institutions.

    This happens so infrequently at Lamar (knock on wood) and we are mostly a social/behavioral university, that we actually have the individual report the event to our office and we contact the IRB Chair for review of the event and ultimate decision.


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    Beverly Kemp
    eRA Research Coordinator
    Lamar University
    Beaumont 77710
    409-880-7670
    brkemp@lamar.edu
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  • 6.  RE: Reporting non-compliance and Adverse Events

    Posted 08-17-2021 10:35
    Hi Angela,

    Like the others, we are mainly an SBER IRB and do not receive incident reports often. Below, is our template for the Incident Report. Our process is: (1) The analyst receives the incident report and routes it to the IRB Chair and Research Compliance Officer; (2) The IRB Chair and Research Compliance Officer review the incident report and corresponding corrective action plan; (3) The Research Compliance Officer notifies the Institutional Official; (4) If the corrective action plan is acceptable, we send correspondence to the PI "noting" the submission (signed by the IRB Chair, Research Compliance Officer, and Institutional Official).

    Template:

    Event Report
    Type of Event
    Check all that apply.

    --
    Provide a description of the events or incidents indicated above.
    Do not include information that might identify a subject.

    Text box provided

    --
    Corrective Action Plan
    Describe how you plan to address the events or incidents reported. This should include any potential changes to the study protocol and any plans to or not to re-consent subjects.

    Note: The IRB may require additional corrective actions.


    Text box provided

    --
    Any changes to the study must be submitted and approved prior to implementation. Complete and submit a Modification Request application.


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    April Gravitt, M.S.
    IRB Administrator
    Office of Research Compliance
    Eastern Michigan University
    Ypsilanti, MI
    anelso43@emich.edu
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  • 7.  RE: Reporting non-compliance and Adverse Events

    CAYUSE CHAMPION
    Posted 08-18-2021 06:26
    Thank you all for sharing. It is really great to see what other institutions are doing.  I am working on re-formatting and re-writing our policies, procedures, SOPs, worksheets, checklists, and Cayuse forms, so I will very likely be reaching out on other topics as well. I appreciate Cayuse giving us this platform to share.  It feels a lot more cozy than posting on PRIMR's site. Such a great resource.

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    Angela Bain, CIP, CIM
    Director, IRB Office
    Kennesaw State University
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