Kris,
I think you would need to enter it as a new initial study, but that would change your previous approval and expiration dates. Would it make sense to submit an additional legacy template with just this record?
The best answer probably depends on the state of your legacy study data. Is is contained in a word document that can easily be edited with changes tracked? A pdf file? How detailed is your modification request form?
We went online in 2015, so the process may be different now, but fo our modifications soon after implementation, we created an option at the very beginning to determine if it was a legacy study or not. At the time, legacy studies were simply headers, and as needed a PDF of the approved study was uploaded. Modifications would require an explanation of the proposed changes, and markups to the original document. In some cases changes were substantial enough that we had the PI submit a new initial submission. Eventually all of the legacy studies closed and all modifications applied to studies started in Cayuse, the the latest modification displayed the approved protocol in its current state.
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Matt Zembrzuski
Research Compliance Manager
American University
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Original Message:
Sent: 02-08-2023 13:05
From: Kris Monahan
Subject: Human Ethics Implementation
I just went live and have someone who wants to modify a proposal which we didn't upload with legacy data. is there a way to enter a study on the back end so the researcher can then just modify it?
Kris
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Kris A. Monahan, Ph.D.
Director Sponsored Projects and Research Compliance
Providence College
Providence, RI
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