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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 2.1.2: Difference between revisions

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|tags_display=[[Glossary:TAG-00066-Cau-enh|Causality]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00045-Adv-hte|Adverse event]], [[Glossary:TAG-00018-Inv-die|Investigator]]
 
|comment=Definition and categories of attribution assessment
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|content=2.1.2. Attribution: An assessment of the relationship between the AE and the medical intervention. After naming and grading the event, the clinical investigator must assign an attribution to the AE using the following attribution categories:
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== Content ==
2.1.2. Attribution: An assessment of the relationship between the AE and the medical intervention. After naming and grading the event, the clinical investigator must assign an attribution to the AE using the following attribution categories:


Unrelated to investigational agent/intervention1
Unrelated to investigational agent/intervention1
Line 61: Line 28:


1NOTE: AEs listed as ‘possibly, probably, or definitely’ related to the investigational agent/intervention in CTEP-AERS are considered to have a suspected ‘reasonable causal relationship’ to the investigational agent/intervention. (ICH E2A)
1NOTE: AEs listed as ‘possibly, probably, or definitely’ related to the investigational agent/intervention in CTEP-AERS are considered to have a suspected ‘reasonable causal relationship’ to the investigational agent/intervention. (ICH E2A)
}}

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 — Unit 5.1.3
Scope G
Document part 2.1.2
Language EN
Original entry by Florian Adragna
Contributors
Tags Causality, Definition, Adverse event, Investigator

Content

2.1.2. Attribution: An assessment of the relationship between the AE and the medical intervention. After naming and grading the event, the clinical investigator must assign an attribution to the AE using the following attribution categories:

Unrelated to investigational agent/intervention1 

  Unrelated
     The AE is clearly NOT related to the intervention
  Unlikely
     The AE is doubtfully related to the intervention

Related to investigational agent/intervention1 

  Possible
     The AE may be related to the intervention
  Probable
     The AE is likely related to the intervention
  Definite
     The AE is clearly related to the intervention

1NOTE: AEs listed as ‘possibly, probably, or definitely’ related to the investigational agent/intervention in CTEP-AERS are considered to have a suspected ‘reasonable causal relationship’ to the investigational agent/intervention. (ICH E2A)

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