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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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== Document Information ==
{{:Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024}}
{{:Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024}}


== Reference Details ==
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! scope="row" style="width:200px;" | Scope
! colspan="2" class="gplx-infobox-header" | Reference Details
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| G
| G
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|-
! scope="row" style="width:200px;" | Document part
! Document part
| 5.2
| 5.2
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|-
! scope="row" style="width:200px;" | Language
! Language
| EN
| EN
|-
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! scope="row" style="width:200px;" | Original entry by
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| Florian Adragna
| Florian Adragna
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|-
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! scope="row" style="width:200px;" | Tags (EN)
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! scope="row" style="width:200px;" | Tags (FR)
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! scope="row" | Comment
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| Pre-treatment adverse events
| Pre-treatment adverse events
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== Text ==
== Content ==
5.2 Pre-Treatment AEs
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 14:27, 29 June 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
Scope G
Document part 5.2
Language EN
Original entry by Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment Pre-treatment adverse events

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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