AE ar SAE sar SUSARSafety reporting requirements for inds and BA BE studiesich guideline for clinical safety data management: definitions and standards for expedited reportingSUSAR Definition | Law Insider
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SUSAR means a suspected unexpected serious adverse reaction resulting from any Clinical Trial or administration of a Product. ... SUSAR means a suspected ... SUSARdefinitionFilter&SearchDefinition:SUSARContractTypeJurisdictionCountryIncludeKeywordsExcludeKeywordsAdditionalfiltersareavailableinsearchOpenSearchRelatedDefinitionsSARNQSOISOStockOptionStockReloadOptionReloadOptionCompanySARtheawardNumberofOptionSharesOptionHolderPerformanceStockAwardOptionAwardRestrictedAwardIncentiveOptionIncentiveShareOptionParentStockOptionNonstatutoryStockOptionNSOContractAwardDateDateofOptionGrantAppreciationRightTandemSARAwardeeNumberofOptionsOptionGrantDateRestrictedShareAwardRemoveAdvertisingOpenSplitViewShareCiteSUSAR meansasuspected,unexpected,seriousadversereaction,inrelationtowhichnotificationtoacompetentauthorityisrequired;Sample1Sample2Sample3Basedon7documents7SaveCopyRemoveAdvertisingSUSAR meansasuspectedunexpectedseriousadversereaction,withoutregardtocausality,thatislife-threatening(i.e.,causesanimmediateriskofdeath)orthatresultsinanyofthefollowingoutcomes:death;in-patienthospitalizationorprolongationofexistinghospitalization;persistentorsignificantdisabilityorincapacity(i.e.,substantialdisruptionoftheabilitytoconductnormallifefunctions);oracongenitalanomalyorbirthdefect.Forclarity,aplannedmedicalorsurgicalprocedureisnot,initself,aSUSAR.Sample1Sample2Sample3Basedon7documents7SaveCopySUSAR meansSuspectedUnexpectedSeriousAdverseReaction.Sample1Sample2Sample3Basedon4documents4SaveCopyMoreDefinitionsofSUSARSUSAR meansasuspectedunexpectedseriousadversereactionresultingfromanyClinicalTrialoradministrationofaCompound,ProductoranyotherImmTACtoahumanbeing;Sample1Sample2Basedon4documents4SaveCopySUSAR meansasuspectedunexpectedseriousadversereactionresultingfromanyClinicalTrialoradministrationofaProduct.Sample1Sample2Basedon2documents2SaveCopySUSAR meansasuspectedunexpectedseriousadversereaction.Sample1Basedon1documents1SaveCopySUSAR meansasuspectedunexpectedseriousadversereaction,withoutregardtocausality,thatislife-threatening(i.e.,causesanimmediateriskofdeath)orthatSpecifictermsinthisExhibithavebeenredactedbecausesuchtermsarebothnotmaterialandwouldlikelycausecompetitiveharmtotheCompanyifpubliclydisclosed.TheseredactedtermshavebeenmarkedinthisExhibitwiththreeasterisks[***].resultsinanyofthefollowingoutcomes:death;in-patienthospitalizationorprolongationofexistinghospitalization;persistentorsignificantdisabilityorincapacity(i.e.,substantialdisruptionoftheabilitytoconductnormallifefunctions);oracongenitalanomalyorbirthdefect.Forclarity,aplannedmedicalorsurgicalprocedureisnot,initself,aSUSAR.1.1.148“Term”hasthemeaningascribedtosuchterminSection14.1.Sample1Basedon1documents1SaveCopyRemoveAdvertisingSUSAR meansasuspected,unexpected,seriousadversereaction,inrelationtowhichSample1Basedon1documents1SaveCopySUSAR meansSuspectedUnexpectedSeriousAdverseReaction;Sample1Basedon1documents1SaveCopySUSAR meansaserious,unexpectedorsuspectedAdverseReaction.Sample1Basedon1documents1SaveCopy
延伸文章資訊
- 1Suspected unexpected serious adverse reaction (SUSAR)
- 2SUSAR: How can they be defined - Endpoint Adjudication
Serious Unexpected Suspected Adverse Reactions (SUSAR): How can they be defined? The recording an...
- 3SUSAR: How can they be defined - Endpoint Adjudication
- 4Suspected unexpected serious adverse reaction (SUSAR)
Definition: Any unfavourable occurrence in a trial participant that is judged to have a major imp...
- 5Adverse Events (SAEs, SUSARs, SADEs, etc.)
An SAE that occurs during research with a medicinal product may be a SAR or a SUSAR. SUSAR is sho...
