Angela,
I appreciate your response.
We are an office of 2. The IRB analyst essentially was doing the normal post-approval monitoring in flagging the closure report for an IRB member. We needed "scientific" eyes on it and guidance on whether to request the Data Safety Monitoring file, etc.
It's rare that we need IRB member eyes on a Closure, but when we do, we wanted to see if we hadn't thought of something we could do/route in Cayuse.
Regards,
Darcy
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Darcy Hammar
Director, HRPP
Rocky Mountain University of Health Professions
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Original Message:
Sent: 08-09-2022 10:42
From: Angela Bain
Subject: Human Ethics - Closures with issues/share with IRB member
I do not have a solution that incorporates cayuse but it sounds like something a post approval monitor would handle. Perhaps your coordinator who handles closures could also hold the title of post approval monitor. This was something that I did at my former institution. I took over all of the closures, continuing reviews, and modifications as post approval monitor and would handle all of the situations like this with educational moments and even bring to the attention of the committee if necessary as part of the process.
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Angela Bain, CIP, CIM
Director, IRB Office
Kennesaw State University
Original Message:
Sent: 08-03-2022 08:49
From: Darcy Hammar
Subject: Human Ethics - Closures with issues/share with IRB member
Hi all,
I'm wondering what you do when you'd really like a member of the IRB to review the closure and provide feedback on a response to the PI.
An example of this is when the PI has over-enrolled or notes there were Adverse Events that were not reported. We most often see these issues with graduating students and an Incident Report is not timely or useful in what is essentially is now an educational moment.
Since you can't route a Closure Report, what do you do? Are there any "in Cayuse" solutions we haven't thought of?
Regards,
Darcy
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Darcy Hammar
Director, HRPP
Rocky Mountain University of Health Professions
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