Table 2.

Trial and Regulatory Reporting of Expected and Unexpected Adverse Events

Pre IND Studies
Adverse events	Trial Reporting/Actions	Regulatory Reporting
Expected1	Record within Protocol CRFs Notify DSMB or IACUC if serious	Upon study completion, if agent moves to IND submission then all trial data should be provided with accompanying study narrative.
Unexpected2	Record within Protocol CRFs Notify DSMB and IACUC Notify investigators, modify consent form if serious	Upon study completion, if agent moves to IND submission then all trial data should be provided with accompanying study narrative
Post IND Studies
Adverse events	Trial Reporting/Actions	Regulatory Reporting
Expected	Record within Protocol CRFs Notify DSMB or IACUC if serious	Upon study completion all trial data should be provided with accompanying study narrative
Unexpected	Record within Protocol CRFs Notify DSMB and IACUC Notify investigators, modify consent form if serious	If serious, 15-day report of events to the study sponsor, (IND file and IRB) Upon study completion all trial data should be provided with accompanying study narrative

¹Expected adverse events: may be drug-related (predicted by the mechanism of action of the drug or its evaluation in purpose-bred animals or other species), disease-related (predicted by the literature or experiential evidence in the veterinary oncology space), and/or study-related (i.e. associated with participation in the study; for example sedated procedures within the study).

²Unexpected adverse events: all other adverse events that occur in the conduct of a study. It is important to note that expected adverse events may be defined as unexpected based on unexpected severity, pattern of response to supportive measures, or duration of the event.