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.

SUSAR means a suspected, unexpected, serious adverse reaction, in relation to which notification to a competent authority is required;

Examples of SUSAR in a sentence

• Institution will retain SUSAR reports consistent with Section 11.3 of this Agreement.

• Such obligation shall not apply where the SUSAR is specific to a particular Licensed Product and which does not have utility or is not relevant to Licensed Products more generally.

• Instituce uchová hlášení SUSAR v souladu s článkem 11.3 této Smlouvy.

• If (a) any suspected unexpected serious adverse reactions (SUSAR) or any reportable serious adverse events (SAEs) may, in Genmab’s reasonable opinion, have a material impact on the Development of a Product or (b) a public announcement has to be made with respect to a SUSAR or SAE related to a Product, then in each case Genmab shall promptly notify CureVac in writing.

• Zadavatel zaručuje, že zavedl účinný systém pro centralizované sledování a oznamování zkoušejícím na zúčastněných pracovištích klinických hodnocení a příslušným regulačním orgánům o všech nálezech, které by mohly nepříznivě ovlivnit bezpečnost pacientů účastnících se Studie, mimo jiné včetně všech zaznamenaných SUSAR jakýmkoli pacientem, který se účastní Studie na jakémkoli pracovišti.

• Promptly following the disclosure of a SUSAR to UHN, at UHN’s request, Avro shall provide all patient data with respect to such SUSAR and other information that is reasonably requested by UHN to UHN, in each case for patient care purposes or to enable UHN to comply with any applicable laws, rules or regulations, and Avro shall discuss and answer all reasonable questions from UHN relating thereto.

• In the event of a discrepancy in the assessment of the reportability of a SUSAR or SADR, the more conservative approach should be taken and the case shall be reported in the Territories of both parties as needed.

• If a public announcement has to be made with respect to any SUSAR or SAE related to a Product, Genmab shall, to the extent reasonably possible and provided that this can be done without risk of non-compliance with Applicable Law (including securities laws and stock exchange rules), notify CureVac thereof at least [*****] prior to making such public announcement to give CureVac an opportunity to comment.

• The Lead Trial Site confirms that if the Principal Investigator has assessed and determined that the adverse event is categorised as a SUSAR, the Principal Investigator will call an urgent Clinical Trial meeting (“Exceptional Investigator Team Meeting”).

• Inštitúcia bude uchovávať správy o SUSAR v súlade s časťou 11.3 tejto zmluvy.

More Definitions of SUSAR

SUSAR means a suspected unexpected serious adverse reaction resulting from any Clinical Trial or administration of a Product.

SUSAR means Suspected Unexpected Serious Adverse Reaction;

SUSAR means a suspected unexpected serious adverse reaction, without regard to

SUSAR means a suspected, unexpected, serious adverse reaction, in relation to which