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  • 1.  Human Ethics - Continued Review Process

    Posted 08-09-2022 04:35
    Hi everyone,

    We have been using Cayuse for about 8 months now and are having a hard time figuring out a process for continued reviews in the system. We are trying to keep the review type consistent for the protocol including any modifications and continued reviews but some of the continued reviews that are submitted, protocols that were once full board, do not need to be reviewed as full board based on the specific submission.

    I came across another thread asking Cayuse about having a review type for the overall study at the study level and then the option to be able to manually change it based on the submission, mods and CRs. This would be a great idea but I do not think that it ever came into fruition.

    Are others having difficulty with this process and if not, how are you currently managing continued reviews in Cayuse?

    Thank you in advance for any feedback or guidance!

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    Emily Murphy
    Research Compliance Manager
    Bowdoin College
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  • 2.  RE: Human Ethics - Continued Review Process

    Posted 08-10-2022 06:02
    Emily,

    When we have a full board renewal/continuing review that qualifies for expedited review, we use the full expedited review toggle in the review level assignment screen. This allows to for processing of the full board submission using the expedited process. The same applies for full board modifications that qualify for expedited review.

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    Whitney McAllister
    Director, Human Research Protection Program
    Wright State University
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  • 3.  RE: Human Ethics - Continued Review Process

    Posted 08-10-2022 07:49
    Hi Whitney, thank you for clarifying as I was thinking this is how we will handle renewals/mods as well.

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    Emily Murphy
    Research Compliance Manager
    Bowdoin College
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  • 4.  RE: Human Ethics - Continued Review Process

    RISING STAR CONTRIBUTOR
    Posted 08-10-2022 06:04
    Emily, is the problem that a study is listed as "Full" but you had a continuing review reviewed under expedited procedures because the interaction with subjects has ended, or are you referring to something else?  We have not really had any issues with continuing review, as the analyst can assign the review as expedited or full board review. The "check in date" has been problematic because it only occurs once and we would prefer to send the reminder on an annual basis (remember to report any incidents,  file a modification submission if there are proposed changes, file a closure submission if the work is complete....)

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    Matt Zembrzuski
    Research Compliance Manager
    American University
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  • 5.  RE: Human Ethics - Continued Review Process

    Posted 08-10-2022 07:47
    Hi Matt, it is the first concern that you mentioned. I was just worried about consistency but I think I now have a better understanding of what others are doing. And yes, the check-in date is problematic for us too. Thanks for your response!

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    Emily Murphy
    Research Compliance Manager
    Bowdoin College
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  • 6.  RE: Human Ethics - Continued Review Process

    Posted 08-10-2022 08:00
    According to the implementation team, Cayuse can send out periodic check-in's more than once. The date specified during the review process is the date the first reminder goes out. Then all additional reminders go out per the time period setting in Application settings under notifications and messages, frequency of admin check-in reminders.

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    Whitney McAllister
    Director, Human Research Protection Program
    Wright State University
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  • 7.  RE: Human Ethics - Continued Review Process

    Posted 08-10-2022 07:24
    Hi Emily,

    I'm piggybacking off of Matt a little bit here.  With a continuing review submission the assigned analyst chooses the type of review the submission goes through.  I'm the analyst for our institution and the way the type of review is chosen for studies is from that study's previous continuing review, or initial review if it hasn't gone through a continuing review yet (for example, an initial study is reviewed by two of our board members and after presented at our meeting it is voted for annual full-board review.  I make note of this in the internal notes section of the approval in Cayuse and when the study is up for review the following year I automatically assign it as full-board).  The majority of our continuing reviews are full-board, but some go through expedited review if the study is closed to enrollment and analyzing data or conducting chart reviews.  For modifications, any changes to the ICF automatically are full-board.  Almost all others go through the expedited review process (i.e. administrative changes or those not affecting subjects).

    I hope this helps answer your question!

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    Rayna Potkonjak
    IRB Coordinator
    Logan Health
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  • 8.  RE: Human Ethics - Continued Review Process

    Posted 08-10-2022 07:51
    Hi Rayna, yes this is helpful. Thank you!

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    Emily Murphy
    Research Compliance Manager
    Bowdoin College
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