OHRE Education Session: Promptly Reportable Information Overview

As of October 1, 2021, the Office for 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:

1. Overview of Definitions – revised definitions
2. Updates to the NSI Form in IRBIS
3. Format changes to the SOP