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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| | |has_document=Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 | ||
| | |module=5 | ||
| | |unit=5.1.3 | ||
| | |scope=G | ||
| | |doc_part=2.1.2 | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
|tags=TAG-00066-Cau-enh ++ TAG-00244-Def-ini ++ TAG-00045-Adv-hte ++ TAG-00018-Inv-die | |||
|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 | |||
|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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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 | ||
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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)
