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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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|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]]
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== 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€’ 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.
}}

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 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.

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