Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 Appendix 1: Difference between revisions
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| | |has_document=Document:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 | ||
| | |module=5 | ||
| | |unit=5.2.4 | ||
| | |scope=G | ||
| | |doc_part=Appendix 1 | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
|tags=TAG-00252-Exp-hle ++ TAG-00253-Rep-att ++ TAG-00011-Inv-tud ++ TAG-00340-Req-nfo | |||
|tags_display=[[Glossary:TAG-00252-Exp-hle|Expedited reporting]], [[Glossary:TAG-00253-Rep-att|Reporting timeline]], [[Glossary:TAG-00011-Inv-tud|Investigational drug (IMP)]], [[Glossary:TAG-00340-Req-nfo|Requirements]] | |||
|comment=Expedited reporting requirements for IND/IDE agents | |||
|content=Appendix 1: Expedited Reporting Requirements for NCI IND/IDE Agents | |||
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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 | 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 | ||
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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 “1” above applies after this reporting period. | 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 “1” above applies after this reporting period. | ||
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Revision as of 12:56, 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 5.2.4 |
| 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 “1” above applies after this reporting period.
