Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.3: 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=1.3 | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
Β | |tags=TAG-00246-Inv-hte ++ TAG-00019-Pri-PrΓΌ ++ TAG-00045-Adv-hte ++ TAG-00259-AEs-ten ++ TAG-00066-Cau-enh | ||
|tags_display=[[Glossary:TAG-00246-Inv-hte|Investigator responsibilities]], [[Glossary:TAG-00019-Pri-PrΓΌ|Principal investigator]], [[Glossary:TAG-00045-Adv-hte|Adverse event]], [[Glossary:TAG-00259-AEs-ten|AE severity]], [[Glossary:TAG-00066-Cau-enh|Causality]] | |||
Β | |comment=Clinical investigator responsibility for AE reporting | ||
|content=1.3 Investigator Responsibility | |||
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1.3 Investigator Responsibility | |||
β’ Clinical investigators and ultimately the protocol Principal Investigator (PI) have the primary responsibility for AE identification, documentation, grading, and assignment of attribution to the investigational agent/intervention prior to reporting to relevant NCI staff for review. | β’ Clinical investigators and ultimately the protocol Principal Investigator (PI) have the primary responsibility for AE identification, documentation, grading, and assignment of attribution to the investigational agent/intervention prior to reporting to relevant NCI staff for review. | ||
β’ It is the responsibility of the investigators to supply the medical documentation needed to support the expedited AE reports in a timely manner. Failure to provide the requested information may result in the suspension of the investigator. | β’ It is the responsibility of the investigators to supply the medical documentation needed to support the expedited AE reports in a timely manner. Failure to provide the requested information may result in the suspension of the investigator. | ||
β’ Investigators MUST immediately report to the sponsor any AE that is serious (see section 2.1.22 for definition of SAE) (21 CFR 312.64b, 21 CFR 812). This can be accomplished following the expedited reporting guidelines herein. | β’ Investigators MUST immediately report to the sponsor any AE that is serious (see section 2.1.22 for definition of SAE) (21 CFR 312.64b, 21 CFR 812). This can be accomplished following the expedited reporting guidelines herein. | ||
}} | |||
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 β Unit 5.2.4 |
| Scope | G |
| Document part | 1.3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigator responsibilities, Principal investigator, Adverse event, AE severity, Causality |
Content
1.3 Investigator Responsibility β’ Clinical investigators and ultimately the protocol Principal Investigator (PI) have the primary responsibility for AE identification, documentation, grading, and assignment of attribution to the investigational agent/intervention prior to reporting to relevant NCI staff for review. β’ It is the responsibility of the investigators to supply the medical documentation needed to support the expedited AE reports in a timely manner. Failure to provide the requested information may result in the suspension of the investigator. β’ Investigators MUST immediately report to the sponsor any AE that is serious (see section 2.1.22 for definition of SAE) (21 CFR 312.64b, 21 CFR 812). This can be accomplished following the expedited reporting guidelines herein.
