Expert Answers » Clinical Trials
Clinical Trials Glossary Definition (English)
SAE Defined
The following is in context to Clinical Trials, because it's common for a single word to have multiple meanings you will find additional research links near the bottom of the page.
"As defined by ICH Guideline E2A and federal regulations at Federal Register 62, Oct. 7, 1997, an Adverse Event becomes a SAE when it results in any one of the following outcomes:
* Death;
* Life-threatening event;
* Inpatient hospitalization or prolongation of existing hospitalization;
* Persistent or significant disability/incapacity;
* A congenital anomaly/birth defect; or
* An important medical event that may not result in death, be life threatening or require hospitalization though, based upon appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent one of the previously identified outcomes."
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Additional SAE Definition Starting Points
The following links are listed in alphabetical order. Please note we cannot guarantee SAE definitions are contextually accurate to Clinical Trials at third party websites.
