Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 4.3: 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=4.3 | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
|tags=TAG-00252-Exp-hle ++ TAG-00253-Rep-att ++ TAG-00046-Ser-sSc ++ TAG-00011-Inv-tud | |||
|tags_display=[[Glossary:TAG-00252-Exp-hle|Expedited reporting]], [[Glossary:TAG-00253-Rep-att|Reporting timeline]], [[Glossary:TAG-00046-Ser-sSc|Serious adverse event]], [[Glossary:TAG-00011-Inv-tud|Investigational drug (IMP)]] | |||
|comment=Expedited AE (SAE) reporting timelines | |||
|content=4.3 Expedited AE (i.e., SAE) Reporting Timelines | |||
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4.3 Expedited AE (i.e., SAE) Reporting Timelines | |||
Appendices 1 and 2 detail the expedited reporting requirements for AEs that occur on trials utilizing an agent under an NCI IND/IDE or CIP Studies Using Commercial Imaging Agent(s). The report type/timelines are defined below: | Appendices 1 and 2 detail the expedited reporting requirements for AEs that occur on trials utilizing an agent under an NCI IND/IDE or CIP Studies Using Commercial Imaging Agent(s). The report type/timelines are defined below: | ||
| Line 53: | Line 23: | ||
• 15 Calendar Day | • 15 Calendar Day | ||
o A complete expedited report on the SAE must be submitted within 15 calendar days of the investigator learning of the event. | o A complete expedited report on the SAE must be submitted within 15 calendar days of the investigator learning of the event. | ||
}} | |||
Latest revision as of 13:50, 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 | 4.3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Expedited reporting, Reporting timeline, Serious adverse event, Investigational drug (IMP) |
Content
4.3 Expedited AE (i.e., SAE) Reporting Timelines
Appendices 1 and 2 detail the expedited reporting requirements for AEs that occur on trials utilizing an agent under an NCI IND/IDE or CIP Studies Using Commercial Imaging Agent(s). The report type/timelines are defined below:
• 24-Hour; 5 Calendar Day o The SAE must initially be reported via CTEP-AERS within 24 hours of learning of the event, followed by a complete expedited report within 5 calendar days of the initial 24-hour report. This is a 2-step process.
• 24-Hour; 10 Calendar Day o The SAE must initially be reported via CTEP-AERS within 24 hours of learning of the event. A complete expedited report on the SAE must be submitted within 10 calendar days of the investigator learning of the event.
• 15 Calendar Day o A complete expedited report on the SAE must be submitted within 15 calendar days of the investigator learning of the event.
