What Is An Adverse Event or AE?

Any unfriendly and negative aspect that came into existence about the product under examination is said to be an adverse event. These can be any side effects of that product, and mostly CRAs have to deal with these events.

Situations like when a person is not feeling well and feeling dizziness, poor vision, blurriness and is losing control of his senses, such cases are also known as an adverse event, but these do not have any warning results. On the contrary, conditions which could be dangerous and life-threatening and can result in the death of a person are described as severe adverse events which can end up with some severe and hazardous results.

These adverse events should be kept in mind and monitored adequately to reduce them as much as possible because if food and drug administration department visits for audit, they will check for any adverse aspects present at your site and in your trial, which can be a problem.

In some companies, minor adverse events are not given proper attention because these are not a big deal to them and results in less report of such events. Having good project investigators is advantageous because they keep everything under consideration because these minor adverse events can transform into severe and threatening adverse events in the future. This can be harmful to the life of the patients by the usage of any improperly investigated product.

These things make these adverse events essential to be kept in mind and under consideration to overcome such unfortunate situations.

 

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