Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.28: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 | ||
| | |module=5 | ||
| | |unit=5.1.1 | ||
| | |scope=G | ||
| | |doc_part=2.1.28 | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
Β | |tags=TAG-00046-Ser-sSc ++ TAG-00244-Def-ini ++ TAG-00258-Ser-nfΓΌ ++ TAG-00320-Foo-eri | ||
|tags_display=[[Glossary:TAG-00046-Ser-sSc|Serious adverse event]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00258-Ser-nfΓΌ|Seriousness criteria]], [[Glossary:TAG-00320-Foo-eri|FDA]] | |||
Β | |comment=Definition of serious adverse event (NCI) | ||
|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: | |||
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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. | 1. Death. | ||
2. A life-threatening adverse drug experience. | 2. A life-threatening adverse drug experience. | ||
| Line 50: | Line 20: | ||
NOTE: SAE and expedited AE are used interchangeably in this document. | NOTE: SAE and expedited AE are used interchangeably in this document. | ||
}} | |||
Latest revision as of 13:50, 16 July 2026
| 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 β 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.
