Suspected Unexpected Serious Adverse Reaction definition

Suspected Unexpected Serious Adverse Reaction. (or “SUSAR”) means all serious adverse events that are suspected to be related to an investigational medicinal product and that are unexpected.
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Suspected Unexpected Serious Adverse Reaction. (SUSAR) – means an adverse reaction, the nature and severity of which is not consistent with the applicable product information:
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Suspected Unexpected Serious Adverse Reaction or “SUSAR” shall mean any Serious Adverse Event, the nature, severity or frequency of which is not consistent with information in the most current investigator’s brochure, or with respect to a marketed product the most current Summary of Product Characteristics (SPC) or Package Insert.
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Examples of Suspected Unexpected Serious Adverse Reaction in a sentence

  • Provide a comprehensive safety management plan to include a Data Safety Monitoring Board (DSMB) and Medical Monitor (MM) and oversee the routine reporting to the DSMB and MM, as well as all required reporting of Adverse Events (“AEs”), Serious Adverse Events (“SAEs”), and expedited reporting of Suspected Unexpected Serious Adverse Reaction (“SUSAR”) associated with the Study Regimen to the FDA within appropriate regulatory reporting periods per 21CFR312.32.


More Definitions of Suspected Unexpected Serious Adverse Reaction

Suspected Unexpected Serious Adverse Reaction. OR “SUSAR” A Serious ADR that is Unexpected. For regulatory reporting purposes, an event of “Death, Cause Unknown” from the Study shall be processed as a SUSAR.
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Related to Suspected Unexpected Serious Adverse Reaction

  • Serious health condition means an illness, injury, impairment, or physical or mental condition that involves:

  • serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following:

  • Acute toxicity means concurrent and delayed adverse effects that result from an acute exposure and occur within any short observation period, which begins when the exposure begins, may extend beyond the exposure period, and usually does not constitute a substantial portion of the life span of the organism.

  • Final Internal Adverse Benefit Determination means an Adverse Benefit Determination that has been upheld by BCBSTX at the completion of BCBSTX’s internal review/appeal process.

  • Serious illness means an accident, injury, illness, disease, or physical or mental condition that: poses imminent danger of death; requires inpatient care in a hospital, hospice, or residential medical facility; or requires continuing in-home care under the direction of a physician or health care provider. Related current definitions are summarized in (f) below.

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  • Adverse System Impact means a negative effect that compromises the safety or reliability of the electric distribution system or materially affects the quality of electric service provided by the electric distribution company (EDC) to other customers.

  • Adverse impact means any deleterious effect on waters or wetlands, including their quality, quantity, surface area, species composition, aesthetics or usefulness for human or natural uses which are or may potentially be harmful or injurious to human health, welfare, safety or property, to biological productivity, diversity, or stability or which unreasonably interfere with the enjoyment of life or property, including outdoor recreation.