What does AESIS mean in VACCINE
AESIs (Adverse Events of Special Interest) are a type of adverse event that is of particular concern due to its potential severity or impact on patient health. They are defined as events that are associated with a higher risk of death, disability, or other serious outcomes.
AESIs meaning in Vaccine in Medical
AESIs mostly used in an acronym Vaccine in Category Medical that means Adverse Events of Special Interest
Shorthand: AESIs,
Full Form: Adverse Events of Special Interest
For more information of "Adverse Events of Special Interest", see the section below.
What does AESIs Stand for?
AESIs stands for Adverse Events of Special Interest.
Meaning of AESIs in MEDICAL
In a medical context, AESIs are events that are considered to be more serious than typical adverse events. They include events that can result in death, life-threatening conditions, hospitalization, persistent or significant disability, or congenital anomalies.
Essential Questions and Answers on Adverse Events of Special Interest in "MEDICAL»VACCINE"
What are Adverse Events of Special Interest (AESIs)?
AESIs are specific adverse events that are of particular concern to clinical trial researchers and regulatory authorities. They are events that are potentially serious, unexpected, or related to the study intervention.
Why are AESIs monitored closely?
AESIs are monitored closely to ensure the safety of study participants. By identifying and tracking these events, researchers can assess the risk and benefits of the intervention and make any necessary adjustments to the study design or protocol.
What are some examples of AESIs?
Examples of AESIs include:
- Serious adverse events
- Unexpected adverse events
- Dose-limiting toxicities
- Safety signals
- Adverse events that require hospitalization or medical intervention
How are AESIs identified?
AESIs are identified through a variety of methods, including:
- Patient interviews and physical examinations
- Laboratory tests and imaging studies
- Medical record reviews
- Safety reporting systems
What happens when an AESI occurs?
When an AESI occurs, the clinical trial team will investigate the event to determine its severity, causality, and potential impact on the study. The investigator may also notify the study sponsor, regulatory authorities, and/or ethics committee.
How can AESIs be mitigated?
AESIs can be mitigated through various measures, such as:
- Careful patient selection and screening
- Appropriate dosing and administration of the intervention
- Close monitoring of participants
- Prompt reporting and investigation of adverse events
- Implementation of risk management plans
Where can I find more information about AESIs?
You can find more information about AESIs from the following resources:
- International Conference on Harmonisation (ICH) website: https://www.ich.org/
- Food and Drug Administration (FDA) website: https://www.fda.gov/
- European Medicines Agency (EMA) website: https://www.ema.europa.eu/
Final Words: AESIs are important to track and monitor because they can provide valuable information about the safety and effectiveness of medical products and treatments. By identifying and reporting AESIs, healthcare professionals can help to improve patient safety and public health.