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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 4.3: Difference between revisions

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Revision as of 17:29, 15 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)
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.

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