New Guidance Announcement: Incident Assessment Tool

Dear Northwestern Research Community,

The IRB Office is pleased to announce the new Incident Assessment Tool (IAT).  The IAT will help reduce the burden on the research community by assisting the Principal Investigator in determining if an incident meets the IRB reporting criteria, how to document the incident (including a root cause analysis and robust Corrective and Preventive Action (CAPA) plan), and what information the IRB expects to see within a robust Reportable New Information (RNI) submission.  

During the initial launch of the IAT, we are requesting researchers complete a brief online survey to share their opinion of the Incident Assessment Tool.  Your participation in this 2-minute survey will help the IRB Office improve our guidance and services to the research community.  The Incident Assessment Tool and survey may be found on the IRB Office Reportable New Information (RNI) page.  

We appreciate and value your feedback!

Thank you,

Northwestern IRB Office