Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.3

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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
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
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Reference Details
Scope	G
Document part	1.3
Language	EN
Original entry by	Florian Adragna
Contributors
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Tags (original language)
Tags (FR)
Comment	Clinical investigator responsibility for AE reporting

Content

1.3 Investigator Responsibility • 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. • 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. • 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.