SUSAR definition

SUSAR means a suspected unexpected serious adverse reaction, without regard to causality, that is life-threatening (i.e., causes an immediate risk of death) or that results in any of the following outcomes: death; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity (i.e., substantial disruption of the ability to conduct normal life functions); or a congenital anomaly or birth defect. For clarity, a planned medical or surgical procedure is not, in itself, a SUSAR.
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SUSAR means a suspected, unexpected, serious adverse reaction, in relation to which notification to a competent authority is required;
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Examples of SUSAR in a sentence

  • No.)EudraCT No. Site No.Patient No. Country AgeSexSuspect Medication # = SUSAR DrugRoute RegimenTreatment Start/Stop or DurationMedical HistorySUSARReported Term Preferred Term (Onset Date)Drug-Event Relationship: Reporter Causality Company Causality Ref.

  • The investigator should notify the IRB or IEC of SUSAR reports as soon as is practical, where this is required by local regulatory agencies, and in accordance with the local institutional policy.

  • However, in these cases the temperature range over which there is evidence for quantum critical scaling is quite small as in the data in Fig.

  • A SUSAR (Suspected, Unexpected Serious Adverse Reaction) is a subset of SAEs and will be reported to the appropriate regulatory authorities and investigators following local and global guidelines and requirements.

  • If the event is related to the investigational product and is both serious and unexpected, it is classified as a SUSAR.


More Definitions of SUSAR

SUSAR means a suspected unexpected serious adverse reaction.
Sample 1
SUSAR means a suspected unexpected serious adverse reaction, without regard to causality, that is life-threatening (i.e., causes an immediate risk of death) or that Specific terms in this Exhibit have been redacted because such terms are both not material and would likely cause competitive harm to the Company if publicly disclosed. These redacted terms have been marked in this Exhibit with three asterisks [***]. results in any of the following outcomes: death; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity (i.e., substantial disruption of the ability to conduct normal life functions); or a congenital anomaly or birth defect. For clarity, a planned medical or surgical procedure is not, in itself, a SUSAR. 1.1.148 “Term” has the meaning ascribed to such term in Section 14.1.
Sample 1
SUSAR means a suspected unexpected serious adverse reaction, without regard tocausality, that is life-threatening (i.e., causes an immediate risk of death) or that results in any of the following outcomes: death; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity (i.e., substantial disruption of the ability to conduct normal life functions); or a congenital anomaly or birth defect. For clarity, a planned medical or surgical procedure is not, in itself, a SUSAR.
Sample 1
SUSAR means a suspected, unexpected, serious adverse reaction, in relation to which
Sample 1
SUSAR means a suspected unexpected serious adverse reaction, without regard to causality, that is life-threatening (i.e., causes an immediate risk of death) or that Specific terms in this Exhibit have been redacted because such terms are both not material and would likely cause competitive harm to the Company if publicly disclosed. These redacted terms have been marked in this Exhibit with three asterisks [***]. results in any of the following outcomes: death; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity (i.e., substantial disruption of the ability to conduct normal life functions); or a congenital anomaly or birth defect. For clarity, a planned medical or surgical procedure is not, in itself, a SUSAR. 1.1.148 “Term” has the meaning ascribed to such term in Section 14.1.
Sample 1