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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 2.1.1.: Difference between revisions

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|content=2.1.1. Adverse Event (AE or Adverse Experience): Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product (attribution of ‘unrelated’, ‘unlikely’, ‘possible’, ‘probable’, or ‘definite’). (The International Council for Harmonization [ICH] E2A, E6)
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{{:Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024}}
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! Document part
| 2.1.1.
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| EN
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! Original entry by
| Florian Adragna
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| Definition of adverse event (NCI)
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== Content ==
2.1.1. Adverse Event (AE or Adverse Experience): Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product (attribution of ‘unrelated’, ‘unlikely’, ‘possible’, ‘probable’, or ‘definite’). (The International Council for Harmonization [ICH] E2A, E6)

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 5.1.1
Scope G
Document part 2.1.1.
Language EN
Original entry by Florian Adragna
Contributors
Tags Adverse event, Definition, Medicinal product

Content

2.1.1. Adverse Event (AE or Adverse Experience): Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Therefore, an AE can be ANY unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product (attribution of ‘unrelated’, ‘unlikely’, ‘possible’, ‘probable’, or ‘definite’). (The International Council for Harmonization [ICH] E2A, E6)

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