Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.14.
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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 | |
|---|---|
| Module | Module 5 â Unit 5.1.1 |
| Scope | G |
| Document part | 2.1.14. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Seriousness criteria, Definition, Expedited reporting, Serious adverse event |
Content
2.1.14. Hospitalization (or prolongation of hospitalization): NCI defines hospitalization for expedited AE reporting purposes as an inpatient hospital stay equal to or greater than 24 hours. Hospitalization is used as an indicator of the seriousness of the AE and should ONLY be used for situations where the AE truly fits this definition and NOT for hospitalizations associated with less serious events. (e.g., a hospital visit where a patient is admitted for observation or minor treatment such as hydration and released in less than 24 hours). Furthermore, hospitalization for pharmacokinetic sampling is not an AE, and therefore is not to be reported either as a routine AE or in an expedited report.
