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Serious Adverse Event (SAE) Guidelines

What is a Serious Adverse Event

A serious adverse event is any untoward medical occurrence involving a study participant which:

  • is life threatening

  • requires in patient hospitalisation or prolongation of existing hospitalisation

  • results in persistent or signficiant disability or incapacity

  • requires intervention to prevent permanent impairment or damage

  • results in death

All serious adverse events must be reported in writing to the IMR Institutional Review Board within one week of any study staff member becoming aware of the event.

Steps to Follow

  1. Identify the event and report to Principal Investigator.

  2. Complete the Serious Adverse Event Report. (RTF document 48kB) Please note that this report must also be sent to the Director PNG IMR, Principal Investigator(s) and any other appropriate parties within 24 hours of notification.

  3. Submit the Serious Adverse Event Report electronically to imrirb@pngimr.org.pg or alternatively by post to:

      IMR Institutional Review Board
      Papua New Guinea Institute of Medical Research
      PO Box 60
      Goroka, EHP 441
      Papua New Guinea

IMR Institutional Review Board


Dr William Pomat
IRB Secretary


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