Hi Angela,
Like the others, we are mainly an SBER IRB and do not receive incident reports often. Below, is our template for the Incident Report. Our process is: (1) The analyst receives the incident report and routes it to the IRB Chair and Research Compliance Officer; (2) The IRB Chair and Research Compliance Officer review the incident report and corresponding corrective action plan; (3) The Research Compliance Officer notifies the Institutional Official; (4) If the corrective action plan is acceptable, we send correspondence to the PI "noting" the submission (signed by the IRB Chair, Research Compliance Officer, and Institutional Official).
Template:
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April Gravitt, M.S.
IRB Administrator
Office of Research Compliance
Eastern Michigan University
Ypsilanti, MI
anelso43@emich.edu------------------------------
Original Message:
Sent: 08-13-2021 14:34
From: Angela Bain
Subject: Reporting non-compliance and Adverse Events
Does anyone have any good (or even not so good) templates for non-compliance reports and/or for adverse event reports to share?
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Angela Bain, CIP, CIM
Director, IRB Office
Kennesaw State University
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