Adverse Events (SAEs, SUSARs, SADEs, etc.)

An SAE that occurs during research with a medicinal product may be a SAR or a SUSAR. SUSAR is short for Suspected Unexpected Serious Adverse Reaction. Sometimes ... Skiptocontent Home Submission WMOapplicable NonWMOresearch ApprovalBoardofDirectorsUMCG Biobankand/ordatabank Documents Topics AdverseEvents(SAEs,SUSARs,SADEs,etc.) Contact&Info CompositionMETcUMCG METcUMCGmeetings METcUMCGFee Morepracticalinformation FAQ News AvailabilityMETcOfficeduringholidays&28September2022 ToolboxUMCG:updatechecklistwithSiteSuitabilityForm WhatistheimpactoftheGDPRontheinformedconsentletter? Menu Home Submission WMOapplicable NonWMOresearch ApprovalBoardofDirectorsUMCG Biobankand/ordatabank Documents Topics AdverseEvents(SAEs,SUSARs,SADEs,etc.) Contact&Info CompositionMETcUMCG METcUMCGmeetings METcUMCGFee Morepracticalinformation FAQ News AvailabilityMETcOfficeduringholidays&28September2022 ToolboxUMCG:updatechecklistwithSiteSuitabilityForm WhatistheimpactoftheGDPRontheinformedconsentletter? Search Close AdverseEvents(SAEs,SUSARs,SADEs,etc.) Duringtheclinicaltrialaparticipantmayexperienceso-calledAdverseEvents.Theresearchprotocolshoulddescribehowtodealwiththesetypesofevents. AllSeriousAdverseEvents(SAEs),SeriousAdverseReactionsorSuspectedUnsuspectedSeriousAdverseReactions(SUSARs)mustbereportedtothereviewingMREC.Exceptionsthereofcanbedescribedintheclinicaltrialprotocol. Thereportsmaybecomprisedinaquarterly,semi-annualofannualline-listing.Theline-listingmentioneventsforwhichnoimmediatereporting isrequired.  SeriousAdverseEvent SAE(SeriousAdverseEvent)isanyuntowardmedicaloccurrenceinapatientortrialparticipant,whichdoesnothaveacausalrelationshipwiththetreatment,and: isfatal,and/or islife-threateningforthesubject,and/or makeshospitaladmissionoranextensionoftheadmissionnecessary,and/or causespersistentorsignificantinvalidityorworkdisability,and/or manifestsitselfinacongenitalabnormalityormalformation,and/or could,accordingtothepersonthatcarriesouttheresearch,havedevelopedtoaseriousundesiredmedicalevent,butwashoweverpreventedduetoprematureinterference. SUSAR AnSAEthatoccursduringresearchwithamedicinalproductmaybeaSARoraSUSAR.SUSAR isshortforSuspectedUnexpectedSeriousAdverseReaction.SometimesalsoSARisused.SARstandsfor SeriousAdverseReaction. AnSAEthatoccursduringresearchwithamedicinalproductisaSARifthereisacertaindegreeofprobabilitythattheSAEisaharmfulandundesiredreactiontotheinvestigationalmedicinalproduct,regardlessoftheadministereddose.IftheSARisunexpecteditiscalledaSUSAR.Inthiscase‘unexpected’meansthatthenatureandseverityoftheSARdonotmatchwiththereferencesafetyinformation(RSI)asincludedintheSPCtextorInvestigator’sBrochure. SUSARshavetobereportedtothereviewingMRECfromthemomentthedossierissubmitted.ThiscanbeforeignSUSARsorSUSARsfromthesamemedicinalproductthatoccurredinadifferentstudybythesamesponsorifthisinformationmayhaveconsequencesforthesafetyoftheresearchsubjectsinthestudythatissubmittedforreview. SADE AnSAEthatoccursduringresearchwithamedicaldevicemaybeaSADE.SADEistheabbreviationforSeriousAdverseDeviceEffect. Whenandwheremustaneventbereported? AfatalSAEand/orlife-threateningfortheparticipantmustbereportedtothereviewingMRECandtheCCMOwithin7daysafterthesponsorhasbeenmadeaware. SAEsthatfallwithintheothercategoriesmustbereported within15days. Howmustitbereported? Investigatorinitiatedresearch SAEscanbereportedviatheportalinToetsingOnline. TheMRECwillbenotifiedofanewreport.ThenotificationwillbereviewedandsavedinToetsingOnline.Theapplicantreceivesacopyofthereviewviaemail. Sponsoredclinicaltrial Incaseofasponsorisacommercialprofit-seekingparty,SAEscanbesubmittedforreviewviaemail,CD-ROMorUSBdrive. Flowcharts. TheCCMOhassomeflowcharts(inDutch)whichgiveforeachtypeofresearchanoverviewofthereportingprocedurewithamoredetailedexplanation,aswellastheexceptionsthatapply. Printorexporttopdf ManageCookieConsent Wijgebruikencookiesomonzewebsiteenonzeserviceteoptimaliseren. Functionelecookies Functionelecookies Alwaysactive Thetechnicalstorageoraccessisstrictlynecessaryforthelegitimatepurposeofenablingtheuseofaspecificserviceexplicitlyrequestedbythesubscriberoruser,orforthesolepurposeofcarryingoutthetransmissionofacommunicationoveranelectroniccommunicationsnetwork. 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