Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.4

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 5.3.6
Scope	G
Document part	1.4
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	DSUR, Sponsor responsibilities, Investigational drug (IMP), Medical device, FDA

Content

1.4 Sponsor Responsibility • It is the responsibility of the sponsor to submit an IND/IDE for clinical trials conducted with investigational agents/interventions subject to FDA 21 CFR 312 and 21 CFR 812, and to ensure that FDA and all participating investigators are promptly informed of significant new AEs or risks with respect to the drug/device (21 CFR 312.50, 21 CFR 812). • It is the responsibility of the sponsor to determine attribution for SAEs with respect to the drug/device. • The sponsor shall notify the FDA and all participating investigators in a written IND Safety Report, as specified in FDA 21 CFR 312.32 (or 21 CFR 812 for an IDE), of:

   Any suspected adverse reaction that is both serious and unexpected.
   Any findings from laboratory animal or in vitro testing that suggest a significant risk for human subjects, including reports of mutagenicity, teratogenicity, or carcinogenicity.
   Any findings from epidemiological studies, pooled analysis of multiple studies, or clinical studies, whether or not conducted under an IND/IDE and whether or not conducted by the sponsor, that suggest a significant risk in humans exposed to the investigational agent.
   Any clinically important increase in the rate of a serious suspected adverse reaction over the rate stated in the protocol or Investigator’s Brochure (IB).

In the Annual Report to the IND/IDE, the sponsor shall submit a summary of the previous year’s clinical investigations, including most frequent and most serious AEs, IND and IDE safety reports, subjects who died (with the cause of death), and subjects who dropped out in association with an AE, whether or not thought to be drug/device related (see 21 CFR 312.33 or 21 CFR 812 for more details).