New Zealand Health and Disability Ethics Committees


 
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Reporting of Serious Adverse Events (SAEs)


Researchers are required to report Serious Adverse Events (SAEs) that occur during a research project to the ethics committee that gave ethical approval to the project. SAEs happening in New Zealand should be reported as soon as possible on the Notification/Receipt of Adverse Event Form.

Protocol waivers should be reported annually as part of the annual report on the research project.

Serious adverse events will only be accepted if they:
  1. are attached to the Notification/Receipt of Adverse Events form
  2. are signed by the principal investigator
  3. include a comment on whether he/she considers there are any ethical issues relating to this study continuing due to this adverse event.

The Principal Investigator is required to inform the Committee as soon as possible of the following:
  • any related study in another country that has stopped due to serious or unexpected adverse events
  • withdrawal of investigational product for continued development
  • withdrawal from the market for any reason
  • all serious adverse events occurring during the study in New Zealand which result in the investigator or sponsor breaking the blinding code at the time of the SAE or which result in hospitalisation or death
  • all serious adverse events occurring during the study worldwide which are considered related to the study medicine. Where there is a data safety monitoring board in place, serious adverse events occurring outside New Zealand may be reported quarterly.

All SAE reports must be signed by the Principal Investigator and include a comment on whether he/she considers there are any ethical issues relating to this study continuing due to this adverse event.

If the adverse event is local and does not have the sponsor’s report attached, an opinion on whether the event is thought to be related to the study should be given along with any other pertinent information. The comments box on the adverse event report form can be extended if necessary of a separate letter attached.

If the study is a multi-region study, then the form should be signed by the Principal Investigator for New Zealand and forwarded to the Multi-region Ethics Committee only. The Committee will assume that the principal investigator, by signing the form, has undertaken to ensure that other investigators and study staff are made aware of the event.

The adverse event report form will be signed by the Chairperson or Deputy Chairperson and returned as the Committee's confirmation of receipt.

Page last updated: 21 December 2007