Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.2

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)