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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 5.2: Difference between revisions

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|tags_display=[[Glossary:TAG-00045-Adv-hte|Adverse event]], [[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00252-Exp-hle|Expedited reporting]], [[Glossary:TAG-00033-Pro-oto|Protocol]]
 
|comment=Pre-treatment adverse events
{| class="wikitable gplx-infobox"
|content=5.2 Pre-Treatment AEs
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 5 — Unit 5.1.1
|-
! Scope
| G
|-
! Document part
| 5.2
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[Glossary:TAG-00045-Adv-hte|Adverse event]], [[Glossary:TAG-00029-Inf-rte|Informed consent]], [[Glossary:TAG-00252-Exp-hle|Expedited reporting]], [[Glossary:TAG-00033-Pro-oto|Protocol]]
|-
! Comment
| Pre-treatment adverse events
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== Content ==
5.2 Pre-Treatment AEs
A pre-treatment adverse event is an adverse event that occurs after a participant has signed an informed consent, but before intervention has begun.  
A pre-treatment adverse event is an adverse event that occurs after a participant has signed an informed consent, but before intervention has begun.  
Refer to the protocol document to determine routine and/or expedited reporting requirements.
Refer to the protocol document to determine routine and/or expedited reporting requirements.
}}

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 — Unit 5.1.1
Scope G
Document part 5.2
Language EN
Original entry by Florian Adragna
Contributors
Tags Adverse event, Informed consent, Expedited reporting, Protocol

Content

5.2 Pre-Treatment AEs A pre-treatment adverse event is an adverse event that occurs after a participant has signed an informed consent, but before intervention has begun. Refer to the protocol document to determine routine and/or expedited reporting requirements.

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