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
From GxPlex
Gxplex admin (talk | contribs) m 1 revision imported |
imported>GxPlexBot Import from GxPlex Excel |
||
| Line 4: | Line 4: | ||
|RefDocPart=Appendix 1 | |RefDocPart=Appendix 1 | ||
|RefLanguage=EN | |RefLanguage=EN | ||
| | |RefTags=TAG-00252-Exp-hle ++ TAG-00253-Rep-att ++ TAG-00011-Inv-tud ++ TAG-00340-Req-nfo | ||
| | |RefModule=5 | ||
| | |RefUnit=5.2.4 | ||
}} | }} | ||
| Line 14: | Line 14: | ||
|- | |- | ||
! colspan="2" class="gplx-infobox-header" | Reference Details | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Module | |||
| Module 5 — Unit 5.2.4 | |||
|- | |- | ||
! Scope | ! Scope | ||
| Line 30: | Line 33: | ||
| | | | ||
|- | |- | ||
! Tags | ! Tags | ||
| | | [[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 | ! Comment | ||
Revision as of 17:29, 15 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 |
| Comment | Expedited reporting requirements for IND/IDE agents |
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.
