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Reportable Events - Noncompliance and Unanticipated Problems

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Guidance for Event Reporting for BRANY IRB

BRANY forms

Guidance for Event Reporting for External IRBs of Record

For studies under the oversight of an external IRB (other than BRANY), the PI must comply with that IRB’s requirements for submitting reportable events.

Note: Timelines of frequently used external IRB’s:

Western IRB (WIRB):
Within 5 working days after site becomes aware
Advarra IRB:
Within 10 working days after site becomes aware
Within 5 working days after site becomes aware

In addition, investigators approved through external IRBs must report locally occurring unanticipated problems, complaints, and any serious and/or continuing noncompliance to the HRPP Office via the IRB electronic management system or email concurrent with submission of the report to the external IRB. Copies of the report submitted to the external IRB are generally acceptable, but additional information may be requested on an as needed basis.


External IRB Forms

Adverse Event Tracking Log (updated 20 Nov 2018)
Event Reporting Guidance (updated 17 June 2020)
Interim Event Report Form (updated 26 Feb 2020)
BRANY Minor Deviation Log (updated 24 June 2020)