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iRIS: Training group: Investigator IRB Training Required not being set for users during amendment/personnel change

  • 1.  iRIS: Training group: Investigator IRB Training Required not being set for users during amendment/personnel change

    Posted 12-19-2022 06:33

    We continue to struggle one-year post "go-live" with receiving answers from iMedris (now Cayuse) for the iRIS IRB module for what seems like standard IRB business processes.

    We have our iRIS system connected to CITI. When a study personnel is added to the application during initial submission the training group is added to the user. That validates the user's training in CITI/Training Profile for the user against the courses set in the training group. For the initial submission process, this works all fine.

    But we also check training for personnel change amendments where a new study staff is added.

    Expected functionality: The Investigator training group is added to new personnel when added as study personnel is performed through the amendment process.

    Current functionality: When you add new study personnel via an amendment the training group is not added to the user to allow for the automation of training checks during the personnel change amendment process.

    iRIS response: System working as expected. Per our conversation this functionality only works with Initial Review Submission forms and it does not work with KSP amendments that uses the additional ksp data value.

    This is not inline with normal business processes and other IRB products out in the market I have experience with from other institutions. 

    Question: Does your IRIS system assign the training group during the amendment, add study personnel process? If yes, how did you accomplish this? 



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