Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 Appendix 1
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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 5.2.4 |
| Scope | G |
| Document part | Appendix 1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Expedited reporting, Reporting timeline, Investigational drug (IMP), Requirements |
Content
Appendix 1: Expedited Reporting Requirements for NCI IND/IDE Agents
Phase 0 Studies: Expedited Reporting Requirements for Adverse Events that Occur on Studies under an IND/IDE within 30 Days of the Last Administration of the Investigational Agent/Intervention1, 2 [...] ALL SAEs that meet the above criteria MUST be immediately reported to the NCI via CTEP-AERS within the timeframes detailed in the table below. Grade 1-2 Timeframes - 24-Hour notification, 10 calendar days Grade 3-5 Timeframes - 24-Hour notification, 5 calendar days [...] Phase 1 and Early Phase 2 Studies: Expedited Reporting Requirements for Adverse Events that Occur on Studies under an IND/IDE within 30 Days of the Last Administration of the Investigational Agent/Intervention 1, 2 [...] ALL SAEs that meet the above criteria MUST be immediately reported to the NCI via CTEP-AERS within the timeframes detailed in the table below. Grade 1-2 Timeframes - 24-Hour notification, 10 calendar days Grade 3-5 Timeframes - 24-Hour notification, 5 calendar days [...] Late Phase 2 and Phase 3 Studies: Expedited Reporting Requirements for Adverse Events that Occur on Studies under an IND/IDE within 30 Days of the Last Administration of the Investigational Agent/Intervention1, 2 [...] ALL SAEs that meet the above criteria MUST be immediately reported to the NCI via CTEP-AERS within the timeframes detailed in the table below. Grade 1-2 Timeframes - 24-Hour notification, 10 calendar days Grade 3-5 Timeframes - 24-Hour notification, 5 calendar days [...] 1SAEs that occur more than 30 days after the last administration of investigational agent/intervention and have an attribution of possible, probable, or definite require reporting as follows: Expedited 24-Hour notifications are required for all SAEs followed by a complete report ⢠Within 5 calendar days for Grade 4-5 SAEs ⢠Within 10 calendar days for Grade 1-3 SAEs
2For studies using nuclear medicine or molecular imaging IND agents (NM, SPECT, or PET), the SAE reporting period is limited to 10 radioactive half-lives, rounded UP to the nearest whole day, after the agent/intervention was last administered. Footnote â1â above applies after this reporting period.
