Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 4.3

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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	4.3
Language	EN
Original entry by	Florian Adragna
Contributors
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Tags (FR)
Comment	Expedited AE (SAE) reporting timelines

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.