Thank you for reaching out.
Our team has been in conversation with iMedris/Cayuse on this issue for over a year, including a meeting with management all the way up to the Cayuse CEO, without resolution.
And as of today (12/22/2022), once again my open IT ticket is closed without resolution. Here is the information we were provided:
Request: A way to retract and withdraw submissions that have been sent back for corrections or responses to the Study/KSP team and are left unattended with no response and PI or KSP are no longer available to send back to the Board.
Issue: If a response submission has been opened or started by the KSP member and is never returned to the board, the system will not allow the board to unlock, retract and change the study status or outcome since this process may cause data integrity issues.
Solution offered: Have any remaining KSP's submit the pending response back to the board in order to have the board process it correctly, provide the correct outcome and provide the status of "withdrawn".
Issue: There will be times that the remaining ksp's will not be available to send the pending response back to the board.
Solution offered: As an iRIS administrator send the pending response back to the board and in the signature comments line mention and describe that the submission is being administratively submitted due to non availability by the KSP in order to have the submission withdrawn.
Issue: We cannot follow the instructions provided by iRIS IT for staff to submit back the response because to submit back the submission the changes requested form requires a response. Validation errors prevent submitting back the submission without a response.
Next Steps: Since there is no functionality currently in the system that will accommodate the requested, an evaluation of this item will need to be made in order to determine if an an enhancement can be considered that will offer our customer a acceptable solution.
This ticket will be set a "Solved" for now. However, it will be evaluated by our CSM and management team. We will reopen this ticket only if it is determined that the change requested will take place. We apologize for any inconvenience and Thank you for your patience.
Having submissions that were sent back to the study team for changes and the study team just never responds because they abandoned the submission or have left the university is a situation that EVERY IRB will experience. I am writing to the community to find out how they deal with this situation given there is no functionality in iRIS to manage.
I would be happy to schedule any meeting with anyone within Cayuse that can assist in evaluating this issue.
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Rebecca A Ballard
Director, Research Compliance
Texas A&M University-Corpus Christi
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Original Message:
Sent: 12-20-2022 10:38
From: Simon Helton
Subject: iRIS Process to Withdraw a Submission when study team has not provided a response
Hi Rebecca,
I'm sorry this has been such a frustrating experience and appreciate you reaching out here to connect with other customers to see how their processes work!
I spoke with the relevant teams and learned your Customer Success Manager and our Support team are actively working to provide options for solutions to the concerns you raised here and in the other discussion threads.
If you'd like to schedule a follow up meeting or have any additional questions, please let me or your CSM know and we can absolutely do that.
Thank you!
Simon
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Simon Helton
He/him
Community Manager
Cayuse
Original Message:
Sent: 12-16-2022 10:46
From: Rebecca A Ballard
Subject: iRIS Process to Withdraw a Submission when study team has not provided a response
We have been struggling with this issue in iRIS since implementation in 2021 and cannot get any answers from their support team. Can someone, anyone, please tell me how in the iRIS IRB module they withdraw a submission when the study team does not respond after a set time.
Background: A submission is reviewed and sent back to the study team with the changes requested. A follow-up due date is set in the outcome tab. The submission is moved to Pending Response tab in the submission widget and study team receives Response Pending Notification as expected. Time has past and the study team has not provided a response after multiple reminders. We need to withdraw the submission from consideration. We follow the instructions provided to us by iRIS shown in the attached PowerPoint to administratively withdraw the submission.
Here's the problem: After the protocol status is updated to withdrawn, the system still treats the submission as pending. The submission withdrawn still displays in the submissions widget under Pending Reponse tab. The stipulations for the withdrawn submission still shows in the stipulations tracking as open stipulations.
We have struggled with iMedris/Cayuse IT to get an answer. Would anyone be willing to share their method for withdrawing a submission after you sent back changes and not study team response has been received after the allotted time?
Thanks!
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Rebecca A Ballard
Director, Research Compliance
Texas A&M University-Corpus Christi
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