Until now, we have discussed what safety reporting is and how it works. But today, we will answer another important question related to this topic:
What does a serious health threat mean?
In other words, how do you know if something constitutes a serious health threat? The purpose of safety reporting is to aid in avoiding these types of events but to understand that, it is important to understand how a serious health threat is defined.
As outlined by the ISO14155 standard, a serious health threat is any adverse event or device deficiency that signals an indication of an imminent risk of death or even a serious deterioration of health. It requires immediate action to be taken, by either the sponsor or the investigator.
The use of safety reporting in clinical investigations, helps avoid and prevent such threats.
Terms and definitions such as these are regularly updated to ensure that the understanding is always clear. The full definition can be found in the ISO14155 standard.