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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 5.3.1: Difference between revisions

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|comment=Persistent adverse events: definition and handling
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|content=5.3.1 Persistent AE
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== Content ==
5.3.1 Persistent AE


A persistent AE (e.g., chronic) is one that extends continuously, without resolution between treatment cycles/courses.
A persistent AE (e.g., chronic) is one that extends continuously, without resolution between treatment cycles/courses.
Line 53: Line 20:
Instructions for EXPEDITED reporting:
Instructions for EXPEDITED reporting:
β€’ If the AE meets Expedited reporting requirements (See Appendices 1 and 2), it should be reported only once unless the grade becomes more severe in the same (submit an amendment to the original expedited report) or a subsequent course (submit a new expedited report associated with the subsequent course).
β€’ If the AE meets Expedited reporting requirements (See Appendices 1 and 2), it should be reported only once unless the grade becomes more severe in the same (submit an amendment to the original expedited report) or a subsequent course (submit a new expedited report associated with the subsequent course).
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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 β€” Unit 5.2.4
Scope G
Document part 5.3.1
Language EN
Original entry by Florian Adragna
Contributors
Tags Adverse event, Definition, Expedited reporting, Requirements

Content

5.3.1 Persistent AE

A persistent AE (e.g., chronic) is one that extends continuously, without resolution between treatment cycles/courses. Instructions for ROUTINE reporting: β€’ For legacy studies utilizing CDUS Complete monitoring, the AE must be reported only once unless the grade becomes more severe in a subsequent course. If the grade becomes more severe in a subsequent course, the AE must be reported again with the new grade. β€’ For Rave studies utilizing DMU Light or DMU Complete, the persistent (ongoing) AE will be copied forward each cycle until an end date is recorded. If the grade becomes more severe on a subsequent course, the original AE must have an end date entered on the original course and the higher-grade AE entered as a new AE in Rave on the subsequent course. NCI will receive these AEs with each DMU data submission. There may be some variation depending on a study’s Rave configuration. β€’ For non-Rave studies utilizing DMU Light or DMU Complete, the AE must be reported only once unless the grade becomes more severe in a subsequent course. If the grade becomes more severe, the AE must be reported again with the new grade in the subsequent course.

Instructions for EXPEDITED reporting: β€’ If the AE meets Expedited reporting requirements (See Appendices 1 and 2), it should be reported only once unless the grade becomes more severe in the same (submit an amendment to the original expedited report) or a subsequent course (submit a new expedited report associated with the subsequent course).

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