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
COMIRB:
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.
