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

  • See the SCI Data Safety and Monitoring Plan (DSMP).• SAEs per 21CFR§312.32 will be reported by the IND-holder, Dr. Nam Bui, to the IND under which this study is being conducted within 7 days (for a life-threatening or fatal event) or15 days (for other SAEs) of the IND-holder’s determination that the SAE meets the criteria for an IND safety report, ie, the event was serious, unexpected, and at least possibly-related to the study drug [a serious, unexpected, suspected adverse reaction (SUSAR)].


More Definitions of SUSAR

SUSAR or “SUSARS” means Suspected Unexpected Serious Adverse Reaction(s).
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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
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Related to SUSAR

  • SAR means a stock appreciation right granted under the Plan.

  • ISO means an employee incentive stock option described in Section 422(b) of the Code.

  • Stock Option means a contractual right granted to an Eligible Person under Section 6 hereof to purchase shares of Common Stock at such time and price, and subject to such conditions, as are set forth in the Plan and the applicable Award Agreement.

  • Option Holder means a Person or Entity who holds an unexercised and unexpired Option or, where applicable, the Personal Representative of such person.

  • Incentive Share Option means an Option that is intended to meet the requirements of Section 422 of the Code or any successor provision thereto.

  • Nonstatutory Stock Option means an Option not intended to qualify as an Incentive Stock Option.

  • Contract Award Date means the date of the Contract award notice, which may take the form of a purchase order, signed Contract or Notice of Award, issued by the Authority.

  • Appreciation Right means a right granted pursuant to Section 5 of this Plan, and shall include both Tandem Appreciation Rights and Free-Standing Appreciation Rights.