Data & Quality
Adverse Event (AE)
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant administered a pharmaceutical product, regardless of whether it is considered related to the product.
AEs are categorized by seriousness (Serious AE: death, life-threatening, hospitalization, persistent disability, congenital anomaly, or important medical event) and by relationship to study drug (related, possibly related, unrelated). Serious Adverse Events trigger expedited safety reporting under ICH E2A.
Suspected Unexpected Serious Adverse Reactions (SUSARs) must be reported to regulators within 7 days (fatal/life-threatening) or 15 days (other serious unexpected). MedDRA is the standard adverse-event terminology dictionary.
Related terms
Serious Adverse Event (SAE)
A Serious Adverse Event (SAE) is any adverse event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, is a congenital anomaly, or is an important medical event per investigator judgment.
Pharmacovigilance
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems, across both clinical trial and post-marketing settings.
Data Monitoring Committee (DMC)
A Data Monitoring Committee (DMC), also called a Data and Safety Monitoring Board (DSMB), is an independent group of experts that periodically reviews accumulating trial data to safeguard participant safety, study integrity, and scientific validity.
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