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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| 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 | |
|---|---|
| Scope | G |
| Document part | 5.3.1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Persistent adverse events: definition and handling |
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: • 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. • 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. • 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: • 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).
