Event Details
Event Title OHRE Education Session: Promptly Reportable Information Overview
Location Zoom
Sponsor NC TraCS (Translational and Clinical Sciences) Institute: NIH CTSA at UNC-CH
Date/Time 09/30/2021 12:00 PM - 1:00 PM
For more information, contact the event administrator: Hannah Kim kim21h@live.unc.edu
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As of October 1, 2021, the Office of Human Research Ethics (OHRE) is releasing an updated SOP #1401. SOP #1401 was previously entitled “New Safety Information” and will now be titled “Promptly Reportable Information”. The SOP has been revised to increase readability by revising the formatting, updating definitions, and amending tables. Also as part of this release we will be offering a new IRBIS form and annotated instructions and examples. The OHRE strongly encourages study personnel to attend this session as it relates to reporting requirements. 

Key Discussion Topics:

Overview of Definitions – revised definitions
Updates to the NSI Form in IRBIS
Format changes to the SOP
UNC - Chapel Hill