Reportable Events - Noncompliance and Unanticipated Problems

Guidance for Event Reporting for BRANY IRB

Information-Sheet-for-Researchers-Reportable-Events
Information-Sheet-for-Researchers-Unanticipated-Problems
Minor-deviation-log-20139201
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
COMIRB:                                  Within 5 working days after site becomes aware
 
If you are unsure of a particular IRB’s requirements, contact either the NJH HRPP Office or the external IRB’s HRPP Office for details.  

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.

If the event does not meet the reportable events criteria (e.g., adverse events not meeting the level of a UP, etc.), please record on the Adverse Events and/or Deviation logs to be submitted to NJH HRPP Office at IRB@NJHealth.org the time of continuing review, along with:

Provide the most recent DSMB/DMC report (as outlined in the protocol) if one is available.

  • Adverse Event Tracking log – a log is provided by Sponsor or Consortium is acceptable. If one is not available, please use version provided below
  • Protocol Deviation Tracking log - a log is provided by Sponsor or Consortium is acceptable. If one is not available, please use version provided below
  • Delegation of Authority log

 

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)