Data & Quality
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.
SAEs must be reported to the sponsor within 24 hours of site awareness; the sponsor then determines reportability to regulators. Unexpected SAEs that are at least possibly related to the investigational product (SUSARs) require expedited regulatory reporting.
SAE narratives prepared for the CSR follow ICH E3 conventions: chronological, factual, with relevant medical history, concomitant medications, lab values, and outcome.
Related terms
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.
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.
Clinical Study Report (CSR)
A Clinical Study Report (CSR) is the comprehensive scientific document, structured per ICH E3, that describes the conduct, methods, and results of a completed clinical trial and is submitted to regulatory authorities to support marketing applications.
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