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Reporting of Serious Adverse Events (SAEs)

A serious adverse event (SAE) is an untoward medical occurrence at any dose that:

• involves a fatal reaction, or
• involves a life-threatening reaction, or
• results in hospitalisation, or prolongs hospitalisation, or
• results in persistent or significant disability or incapacity, or
• results in a congenital abnormality.

Where the application is for a study with a data monitoring committee

SAEs must be individually reported by the principal investigator to the ethics committee that approved the study where they:

• are unexpected because they are not outlined in the investigator’s brochure, and
• are not defined study end-points (e.g. death or hospitalisation), and
• occur in patients located in NZ, and
• if the study involves blinding, result in a decision to break the study code.

There is no requirement for the individual reporting to ethics committees of SAEs that do not meet all of these criteria.

SAEs should be individually reported within the time-frames for expedited reporting set out in ICH guidelines (i.e., as soon as possible but within 7-15 days).

SAE reports must:

• be attached to the Notification/Receipt of Serious Adverse Events form (PDF, 13 KB), and
• be signed by the principal investigator, and
• include a comment on whether the principal investigator considers that there are any ethical issues relating to this study continuing due to this adverse event.

Regular line-by-line reports from the data monitoring committee may also be required, the timing of which will be at the ethics committee’s discretion and will be communicated clearly in the letter of approval.

Where the application is for a study without a data monitoring committee

With regard to the nature of the study, the ethics committee may require that the principal investigator:

• report all SAEs within the timeframes above to the committee, or
• set up a data monitoring committee as a condition of ethical approval.

Page last updated: 11 January 2010