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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Original Message:
Sent: 12-19-2022 06:18
From: Rebecca A Ballard
Subject: iRIS: Able to submit CR, Amendment forms before study Approved
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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