Adverse Events, Deviations & Unanticipated Problems

Guidance for Event Reporting

NJH HRPP/IRB does not accept reports of adverse events and IND Safety Reports that do not meet the definition of an unanticipated problem involving risks to subjects or others (UPIRTSO).

NJH HRPP/IRB does not require reporting a Protocol Deviation unless it involves risk to subjects or compromises data integrity.

If investigators are uncertain but believe that an event or issue might meet the definition of an UPIRTSO or Reportable Protocol Deviation, a report should be submitted along with an analysis by the sponsor or investigator.

Please refer to Event Reporting Guidance and Decision Tree documents to help determine if an event needs to be reported.

If event meets UPIRTSO or Reportable Protocol Deviation please do one of the following:

  • If the protocol has been approved by NJH IRB, please complete the Interim/Event Report form on IRBManager within 7 working days.
  • If the protocol was approved by another IRB of Record, please use Interim/Event Report form below and submit to NJH HRPP Office at IRB@NJHealth.org within 7 working days.

If the event does not meet the promptly reporting criteria, 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.

Please submit the following at continuing review for all IRBs of Record:

  • 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

For non-NJH IRBs, please also provide:

  • Delegation of Authority log

 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 10 March 2020)
Decision Tree Event Reporting (updated 10 March 2020)
Interim Event Report Form (updated 26 Feb 2020)
Protocol Deviation Tracking Log (updated 20 Nov 2018)