Adverse Events, Deviations & Unanticipated Problems

Guidance for Event Reporting

If the decision tree leads to prompt reporting to NJH HRPP Office, please complete the Promptly Reportable Event form and submit to NJH HRPP Office within 7 working days.

If the decision tree leads to only the completion of the Adverse Events and/or Deviation logs to be submitted to NJH HRPP at the time of continuing review, please submit the following:

  • If the IRB of Record is an External IRB, 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 on NJH HRPP webpage

  • Protocol Deviation Tracking log - a log is provided by Sponsor or Consortium is acceptable. If one is not available, please use version provided on NJH HRPP webpage

For further assistance, please call the NJH HRPP office or refer to the NJH HRPP SOP Section 18-21.

 

Reporting Deadlines

Deadlines

  • Within 1 business day

    • Subjects exhibiting signs of high-risk behavior that can potentially cause harm to oneself or others. (The IRB Chairperson must be notified via phone or email within 1 business day. A written report must be submitted to the HRPP office within 3 business days.)

  • Within 7 business days

    • Reportable Event Submission Form must be submitted to the HRPP office within 7 business days of discovery.

 

Forms

Adverse Event Tracking Log (updated 20 Nov 2018)
Event Reporting Guidance (updated 20 Nov 2018)
NJH Reportable Event Submission Form (updated 20 Nov 2018)
Protocol Deviation Tracking Log (updated 20 Nov 2018)