Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.32 - 2.1.34

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 5.1.4
Scope	G
Document part	2.1.32 - 2.1.34
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	SUSAR, Definition, FDA, Sponsor
Comment	Definition of SUSAR (NCI)

Content

2.1.32. Suspected Unexpected Serious Adverse Reaction (SUSAR): An adverse event that occurs in a clinical trial participant, which is assessed by the sponsor as being unexpected, unexpected, serious (See 21 CFR 312.32), and for which there is a reasonable possibility that the drug caused the adverse event (calls for 7-day or 15-day reporting to the FDA based on whether it is fatal/life-threatening or non-fatal/non-life-threatening).

2.1.33. Unexpected Adverse Event: An adverse event that is not listed in the investigator brochure or is not listed at the specificity or severity that has been observed or is not consistent with the risk information described in the Investigator Brochure, CAEPR, SPEER, and/or CRL.

2.1.34. Unanticipated Adverse Device Event (UADE): “Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects” (21 CFR 812.3[s]). UADEs must be reported by the clinical investigator to the sponsor and the reviewing Institutional review Board (IRB), as described below: • For device studies, investigators are required to submit a report of a UADE to the sponsor [NCI] and the reviewing IRB as soon as possible, but in no event later than 10 working days after the investigator first learns of the event (21 CFR 812.150(a)(1)). • Sponsors [NCI] must immediately conduct an evaluation of a UADE and must report the results of the evaluation to FDA, all reviewing IRBs, and participating investigators within 10 working days after the sponsor first receives notice of the effect (21 CFR 812.46(b), 812.150(b)(1)).

NOTE: The IDE regulations, therefore, require sponsors to submit reports to IRBs in a manner consistent with the recommendations made above for the reporting of unanticipated problems under the IND regulations.