Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.28

Document information
Reference	USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024
Validity area	USA
Scope(s)	G
Document name	NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs
Version / Revision	30-Aug-2024
Status	Current
Document type	Other
Language(s)	EN
Description	National Cancer Institute GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 5 — Unit 5.1.1
Scope	G
Document part	2.1.28
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Serious adverse event, Definition, Seriousness criteria, FDA

Content

2.1.28. Serious Adverse Event (SAE): Any adverse drug event (experience) occurring at any dose that results in ANY of the following outcomes: 1. Death. 2. A life-threatening adverse drug experience. 3. Inpatient hospitalization or prolongation of existing hospitalization (for >24 hours). 4. A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions 5. A congenital anomaly/birth defect. 6. Important Medical Events (IME) that may not result in death, be life threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. (FDA, 21 CFR 312.32; ICH E2A and ICH E6)

NOTE: SAE and expedited AE are used interchangeably in this document.