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  • 1.  iRIS: Able to submit CR, Amendment forms before study Approved

    Posted 12-19-2022 06:19

    It has been a year since we went "live" in the iRIS IRB Module. We continue to struggle getting answers from development and iMedris (now Cayuse) management on what seems like simple, routine IRB business processes.

    If anyone has a solution or can confirm their system does or does not work in the same what that would be helpful.

    Desired business process: Study teams cannot amend or submit a continuing review, annual check-in, or study closure until the initial protocol is approved. All child submission forms to a protocol (amendment, CR, study closure) should not be accessible to study teams to complete until the overall protocol status after the initial submission review is complete is set to Approved. This is a standard feature in other systems I have used at other institutions. 


    Current iRIS process: Study teams can access and submit amendment forms, continuing review forms, and study closures before the initial submission process is completed (protocol status is in draft, pending response state). We have a lot of student, first-time users submitting. Every once and while they get confused and submit an amendment in to respond to changes requested on an initial submission,  rather than completing the changes request process. This would be cured if the business process above was available. 

    iRIS response: The system is functioning as expected. iRIS only restricts submission forms with the attached application data value.

    The current state of our system is not in line with what we were promised during the RFP process and implementation. And does not align with other systems in the IRB module workspace. 

    Questions: Does your system restrict study teams from submitting child forms (amendment, CR, RE) until the initial review process is completed and approved? If yes, how did you get iRIS to function this way?



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    Rebecca A Ballard
    Director, Research Compliance
    Texas A&M University-Corpus Christi
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  • 2.  RE: iRIS: Able to submit CR, Amendment forms before study Approved

    Posted 12-20-2022 05:05
    In our system, other submission forms are not locked down and it hasn't posed much of a problem for us other than an occassional submission of an inappropriate form before initial approval.  I am not sure I understand your comment "iRIS only restricts submission forms with the attached application data value" though.  If you want to email me privately off this site, that is fine.  I understand your frustrations though as we have been with the system a long time and don't really like "the system performs as designed.....".

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    Barbara Legate
    Senior Business Systems Analyst
    University of Texas Health Science Center
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  • 3.  RE: iRIS: Able to submit CR, Amendment forms before study Approved

    Posted 12-20-2022 05:45

    Thanks for confirming we are not the only one with this issue. That helps. True. It does not happen too often and we've done extensive training on the system to reduce the error. It just baffles me to even invite this as a problem when every other system I've been in (even the really cheap, outdated software systems) has this functionality. 

    I don't understand the comment either. That is the response we get back from iRIS support IT. I can't get a good explanation in plain English why this functionality is not present.

    Thanks again for taking the time to respond.



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    Rebecca A Ballard
    Director, Research Compliance
    Texas A&M University-Corpus Christi
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  • 4.  RE: iRIS: Able to submit CR, Amendment forms before study Approved

    Posted 02-22-2023 06:15

    It took me about 8 months to get a straight answer from iRIS, but here is what I learned about how to get this functionality:

    You have to add the application data value into your child submission forms. But I didn't want the application to show to the study team in submissions like annual check-ins, continuing review, reportable events, etc. If it shows they could create a new version from within a continue review application. We wanted to cleanly separate amendments from other forms.

    Steps:
    System form designer, open your child submission form.
    Add a question. Question text = IRB application.

    Add data value: Data type = Attach a protocol application.

    Save.

    That attaches the protocol data value to get the greyed out boxes.

    Now set visibility rules if you want to hide from the study team in the form.

    In system form designer, section show visibility, add show visibility to create a new rule.

    Rule: 

    Review board selection Equal Value [select your committee name]

    OR

    Add second rule 'Review board selection Does Not Equal Value [select your committee name]

    Including both options ensures the validation rule will never be true and the application field will not show in the application form. 



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    Rebecca A Ballard
    Director, Research Compliance
    Texas A&M University-Corpus Christi
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