Clinical trials can result in several complications related to the medical conditions of the participants involved in a clinical trial. During a clinical trial, these kinds of situations or events might happen. It is important to have a proper segmentation of events so that a quick and effective management plan can be implemented immediately. There are different reporting processes that need to be followed in different events. Two most common events in a clinical trial are Adverse Events (SE) and Serious Adverse Events (SAE).
Adverse Event (AE):
- Adverse Events refers to any situation where the candidates participating in a clinical trial shows some adverse medical symptoms. These symptoms may be revealed in the laboratory test reports or physically examination of the participants. This term is strictly applicable for the individuals who have been involved or associated with the research for any length of time, short or long.
Serious Adverse Event (SAE):
A Serious Adverse Event (SAE) is actually a special case of an adverse event where adverse outcomes are severe. It includes following events:
- Death of any of the participants associated with a clinical trial
- An event which can lead to life-threatening complications or put the life of participants at risk as a result of participation in a clinical trial.
- Events that result in such a condition where the participants may require immediate hospitalization or increase the duration of hospitalization.
- Any events that lead to a permanent or temporary physical disability in the body of the participants. Any sort of incapacity is also regarded as SAE.
- Any events that lead to any type of congenital abnormalities. It also includes any cases of birth defects resulting from the clinical trials.
- Any events where an investigator or team of investigators finds feel that it can lead to significant hazards.
A clinical trial always carries the risk of undesired outcomes that can even be life-threatening in some cases. Thus, the awareness about the classification of events into Adverse Events and Serious Adverse Events can be extremely helpful in minimizing damage and saving lives of the participants.