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The importance of recognising AEs and SAEs (2)

To protect research subjects through prompt remedial actions

This applies to all kinds of research, whether or not risky interventions are undertaken. ‘Adversity’ may also be interpreted in a broader sense to include both medical and non-medical events (such as social or financial harm).

The fact that ‘something bad’ has occurred to someone when they are a subject in your study means that there is a possibility, however tiny, that they could have been in a better position had they not participated in your study, or if you had conducted your study in a different manner.


For example, although a ruptured appendix is very unlikely to have been caused by answering a 15-minute-long questionnaire, a subject might have received medical treatment fifteen minutes earlier if (s)he had not agreed to spend that time answering your questionnaire; or if you had not been so eager to complete the questionnaire, so much so that you failed to realise that (s)he was unwell.       

 

The recognition that an adverse event has happened does not only allow you to take immediate steps to minimise its severity. It also prompts you to consider whether any aspects of your study might have directly or indirectly contributed to it. If yes, corrective actions can be taken to reduce the chances or severity of any recurrence.