Adverse Events, Deviations & 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

NJH HRPP 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 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 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:

  • 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

 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. An Interim/Event Report Form must be submitted to the HRPP office within 3 business days.)

  • Within 7 business days

    • An Interim/Event Report Form must be submitted to the HRPP office within 7 business days of discovery.

 

External IRB Forms

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