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Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.21.: Difference between revisions

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|comment=Definition of life-threatening adverse event (NCI)
|content=2.1.21. Life-Threatening Adverse Event: Any SAE that places the subject, in the view of either the investigator or the sponsor (NCI), at immediate risk of death from the AE as it occurred. It does NOT include an SAE that, had it occurred in a more severe form, might have caused death. (FDA 21 CFR 312.32, ICH E2A)
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{{:Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024}}
{| class="wikitable gplx-infobox"
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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Module
| Module 5 β€” Unit 5.1.1
|-
! Scope
| G
|-
! Document part
| 2.1.21.
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[Glossary:TAG-00046-Ser-sSc|Serious adverse event]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00069-Imm-rhe|Urgent safety measure]], [[Glossary:TAG-00258-Ser-nfΓΌ|Seriousness criteria]]
|-
! Comment
| Definition of life-threatening adverse event (NCI)
|}
== Content ==
2.1.21. Life-Threatening Adverse Event: Any SAE that places the subject, in the view of either the investigator or the sponsor (NCI), at immediate risk of death from the AE as it occurred. It does NOT include an SAE that, had it occurred in a more severe form, might have caused death. (FDA 21 CFR 312.32, ICH E2A)

Revision as of 12:56, 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 2.1.21.
Language EN
Original entry by Florian Adragna
Contributors
Tags Serious adverse event, Definition, Urgent safety measure, Seriousness criteria

Content

2.1.21. Life-Threatening Adverse Event: Any SAE that places the subject, in the view of either the investigator or the sponsor (NCI), at immediate risk of death from the AE as it occurred. It does NOT include an SAE that, had it occurred in a more severe form, might have caused death. (FDA 21 CFR 312.32, ICH E2A)

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