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 Suspected Unexpected Serious Adverse Reaction.
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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.

  • 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.

  • All investigators will receive a safety letter notifying them of relevant SUSAR reports associated with any study IMP.

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

  • Participating investigators and IEC/IRB will receive a blinded SUSAR summary, unless otherwise specified.

  • The focus of Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting will be on those events that, based on a single case, are highly likely to be related to the study medication.

  • All investigators will receive a safety letter notifying them of relevant SUSAR reports associated with any study drug.

  • As a general rule, treatment codes should be broken/unblinded by the sponsor before reporting a SUSAR.

  • In the European Union (EU), an event meeting these criteria is termed a Suspected, Unexpected Serious Adverse Reaction (SUSAR).


More Definitions of SUSAR

SUSAR means a suspected unexpected serious adverse reaction resulting from any Clinical Trial or administration of a Compound, Product or any other ImmTAC to a human being;
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SUSAR means a suspected unexpected serious adverse reaction.
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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 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. 1.1.146 “Term” has the meaning ascribed to such term in Section 13.1.
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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.

  • NQSO means any Option that is not an ISO.

  • 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.

  • Stock Reload Option means any option granted under Section 6.3, below, as a result of the payment of the exercise price of a Stock Option and/or the withholding tax related thereto in the form of Stock owned by the Holder or the withholding of Stock by the Company.

  • Reload Option means any Option granted under Section 6(a)(iv) of the Plan.

  • Company SAR means any stock appreciation right linked to the price of Company Common Stock and granted under any Company Stock Plan.

  • the award , except in sub-paragraph (2), means—

  • Number of Option Shares means shares of Stock, as adjusted from time to time pursuant to Section 9.

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

  • Performance Stock Award means a Stock Award granted under the terms and conditions of Section 6(c)(i).

  • Restricted Award means any Award granted pursuant to Section 7.2(a).

  • Incentive Option means an Option which by its terms is to be treated as an “incentive stock option” within the meaning of Section 422 of the Code.

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

  • Parent Stock Option means any option to purchase Parent Common Stock granted under any Parent Stock Plan.

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

  • NSO means a stock option not described in sections 422 or 423 of the Code.

  • 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.

  • Date of Option Grant means the effective date of grant of the Option as set forth in the Notice.

  • 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.

  • Initial Authorised Participant means BNP Paribas Arbitrage S.N.C. and any successor thereto.

  • Tandem SAR means an SAR that is granted in connection with a related Option pursuant to Article 7 herein, the exercise of which shall require forfeiture of the right to purchase a Share under the related Option (and when a Share is purchased under the Option, the Tandem SAR shall similarly be canceled).

  • Awardee means the holder of an outstanding Award.

  • Number of Options For each Component, as provided in Annex A to this Confirmation.6 Option Entitlement: One Share Per Option Strike Price: USD [_____] Cap Price: USD [_____]; provided that in no event shall the Cap Price be reduced to an amount less than the Strike Price in connection with any adjustment by the Calculation Agent under this Confirmation.

  • Option Grant Date means, as to any Stock Option, the latest of:

  • Restricted Share Award means an award of Restricted Shares.

Most Referenced Clauses

Most Referenced Definitions