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  • 1.  QA and Reviews

    Posted 01-11-2023 08:45

    Hello to everyone.

    I am a new user and still exploring Cayuse IRB features. I am the HRPP Director and have direct responsibility for all aspects of the IRB, including serving as a designated reviewer. My question is this:
    If in the course of doing some IRB QA you discover that an error was made in a review, what do you do to correct this? I am curious if there is a way to add or edit a review (when the letter has been sent, when the item has been assigned to the board).  I did not see an obvious way to do this.
    Thanks for your help!



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    Gabrielle Rebillard
    HRPP Director
    WellSpan Health
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  • 2.  RE: QA and Reviews

    This message was posted by a user wishing to remain anonymous
    Posted 01-12-2023 06:48
    This message was posted by a user wishing to remain anonymous

    Thanks for bringing up this issue.   We have been unable to identify a mechanism for correcting human errors.  In the past when we discovered an IRB Coordinator error in a letter or a review, Cayuse's response has been to have the study team create a new submission.  However, that approach seems illogical as it would just create a new review, not provide a chance to correct, with documentation, an existing review.  Our previous system allowed us to create a new version of determination letters with an audit trail.  We could post comments about why the letter was changed after it was issued.  The most common reason for these changes was related to expiration dates in the letters.


  • 3.  RE: QA and Reviews

    Posted 01-12-2023 07:13
    Thank you very much for this candid response. This is one of MANY issues I am finding that interfere operations, compliance standards, and ,frankly, common sense. Like everyone, I will have to find a workaround.

    ------------------------------
    Gabrielle Rebillard
    HRPP Director
    WellSpan Health
    ------------------------------



  • 4.  RE: QA and Reviews

    CAYUSE CHAMPION
    Posted 01-12-2023 07:20
    Hi Gabrielle,

    At my institution, we utilize the notes part of the review. Or you can change information in the review by editing it yourself.

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    Alicia Scott
    IRB Director
    The Chicago School of Professional Psychology
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  • 5.  RE: QA and Reviews

    Posted 01-12-2023 07:29
    Thanks for this idea. How do go about changing "information in the review by editing it yourself"? I could not see a way to do this.

    ------------------------------
    Gabrielle Rebillard
    HRPP Director
    WellSpan Health
    ------------------------------



  • 6.  RE: QA and Reviews

    CAYUSE CHAMPION
    Posted 01-12-2023 07:34
    I have different methods, but it depends on where the comments are made. If they make a comment in one of the prompts, I just restrict their comment and don't make it visible to the PI. If changes are needed, then I revise the comment and leave it unrestricted. If they make inaccurate comments in their checklist, I just revise it as appropriate. If there are incorrect comments in the Findings, you can click on the Decision from the Study Details page to revise their comments.

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    Alicia Scott
    IRB Director
    The Chicago School of Professional Psychology
    ------------------------------



  • 7.  RE: QA and Reviews

    Posted 01-12-2023 07:47
    I cannot figure out where/how you can edit anything once the review is done and letter is sent. You cannot reopen the review, add notes, send another letter from the same submission. Perhaps we set up our IRB module differently but this seems to be a system limitation.

    ------------------------------
    Gabrielle Rebillard
    HRPP Director
    WellSpan Health
    ------------------------------



  • 8.  RE: QA and Reviews

    CAYUSE CHAMPION
    Posted 01-12-2023 07:51
    I have not had to send a revised review once the study is approved. But we have sent the wrong letter before. We just had the PIs submit a modification to make any ongoing changes needed. This is a limitation for us as well.

    ------------------------------
    Alicia Scott
    IRB Director
    The Chicago School of Professional Psychology
    ------------------------------