General Discussions

 View Only

IRIS: Stipulation outcome remain editable after rounds

  • 1.  IRIS: Stipulation outcome remain editable after rounds

    Posted 12-19-2022 06:41

    We continue to experience difficulty with iRIS (now Cayse) one year post going live on what seems like routine, normal IRB business processes in our IRB module.

    Stipulation review process: Stipulations are sent back to the study team to resolve. Once the submission is returned with their edits, IRB staff marks the updated status (Approved, Not Met) under the Submissions Detail/Stipulation History. This process works fine.

    The issue comes up when a submission has stipulations that are Not Met and is sent back to the study team to resolve in multiple rounds.

    Expected functionality:  When a submission goes through multiple rounds the analyst should not be able to edit the status or date of the stipulation in the previous round. Prior rounds should be read only and only the current round of stipulations under review are editable to indicate an updated status based on the last revisions sent in.

    Current functionality: Analyst can edit the stipulation status for all rounds at any time.

    We have a lot of student or first-time submitters. It is not unusual for a submission to go back for multiple rounds. Because stipulations are often unmet in previous rounds they are listed in each round. It is easy to lose where you are on the screen and inadvertently update the status on the same stipulation in the previous round and not the current round. Editing the outcome of the stipulations in previous rounds for me creates a huge audit issue because you able to modify what occurred in the past. My experience with other IRB software systems at previous institutions is that data from prior rounds becomes read-only to reviewers so you cannot edit what occurred in previous rounds.

    iRIS response: Current/expected system functionality. 

    Question: Can you edit prior stipulation outcomes in your IRIS IRB module? If no, what setting did you use to make prior stipulations read only? 

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