SUSAR: How can they be defined - Endpoint Adjudication

Serious Unexpected Suspected Adverse Reactions (SUSAR): How can they be defined? The recording and reporting of SUSARs is a cornerstone of the ... Home / EndpointAdjudicationBlog / AdjudicatingSUSAR ByEthical 27Apr,2021 SeriousUnexpectedSuspectedAdverseReactions(SUSAR):Howcantheybedefined? TherecordingandreportingofSUSARsisacornerstoneoftheglobalcontinuoussafetymonitoringsystemwhichprotectssubjectsparticipatinginclinicaltrialsfromunknownoryetundocumentedriskspotentiallylinkedtonewinvestigationaldrugs.SUSARsmustbereportedwithinaveryshorttimeperiodandbeasaccuratelydescribedaspossible.Mostimportantly,thesponsormustmakeanearlydeterminationwhetherthesuspectedadversereactionispotentiallyrelatedtothestudydrugandifitcanbeconsideredexpectedornot.Anindependentadjudicationcommitteemaybethebestwaytoperformthisassessment. Theevaluationofthesafetyofaninvestigationalormarketedmedicinalproductisanevolvingprocess.Availabledatadependonthestageofdevelopment: Allavailablesafetyinformationonapprovedproductsisreflectedinproductlabelling(anddescribedinthePackageInsert).  Up-to-datesafetyinformationontheproductsunderinvestigationisfoundintheInvestigator’sBrochure(IB).ThisincludesinformationgatheredduringInvitrotestingandNonclinicalpharmacology/toxicologystudiesandanyClinicalsafetyandpharmacokineticdatathatmaybeavailablefromearlierclinicalstudies(IBsareregularlyreviewedandupdatedbysponsors).Inshort,forproductsunderinvestigation,theIBisequivalenttothePackageInsert.  Safetymonitoringrevolvesaroundtheidentification,description,recordingandreportingofAdverseEvents(AE)thatcanbefurthercategorizedinvariousways1: UnexpectedAdverseEvents LaboratoryAbnormalities AdverseEventsofSpecialInterest CommonAdverseEvents RareAdverseEvents SeriousAdverseEvents AdverseReactions InvestigatorsareinthefrontlineofAEreportingandarethefirsttomakeanevaluationofthenature,severity,seriousnessandrelationtothestudydrug.TheyareadvisedtobeconsistentandtousescientificterminologywhenreportingAdverseEventsasfailingtodosomayleadtoconfusion,incorrectorinadequatecodingandultimatelymaycauseasafetysignaltobemissed.  ASeriousAdverseEvent(SAE)isanyAdverseEventthatresultsintheopinionoftheInvestigatororSponsorin: Deathorislife-threatening(immediateriskofdeath) Hospitalizationorprolongationofexistinghospitalization Persistentorsignificantincapacityorsubstantialdisruptionoftheabilitytoconductnormallifefunctions(akadisability) Congenitalanomaly/birthdefect Othermedicallysignificantevent InvestigatorsarerequiredtoreportallSAEstotheSponsorwithin24hoursofbeingmadeawareoftheeventandappropriatechannelsareinplacetoallowthis.Therequirementisclearlydescribedanddocumentedinthetrainingdeliveredtothesitesbythesponsor.  OnceanSAEreportisreceivedbytheSponsor,thereneedstobeadeterminationofwhethertheeventshouldbeconsideredaSUSAR.Ifso,theSponsorhas15calendardaystoreportittotheHealthAuthorities(7daysiftheeventisfatalorlife-threatening).ThisallowsHealthAuthoritiestodetectsafetysignalsearlyonandtakeappropriateactionsuchasorderahaltinthestudyorrequestadditionalinvestigations. TheflowchartbelowdescribesthesequenceofeventsstartingwiththeoccurrenceofanAE.OncetheInvestigatorhasmadethejudgementaboutseriousnessandrelationtothestudydrug,thecaseiscommunicatedtotheSponsor.ItisnowuptotheSponsortodeterminewhethertheeventisaSUSARandtotriggeranexpeditereportingprocess.  Figure1FlowchartofSURARreporting WhatshouldbeconsideredanUnexpectedAdverseEvent?3AnyAdverseEventthatfulfillsthefollowingconditionsshouldbeconsideredasunexpected: NotlistedintheInvestigator’sBrochure(IB)orifIBnotavailableorrequired Notlistedatthespecificityorseverityobserved MentionedinIBasanticipatedduetopharmacokineticpropertiesofthedrugoroccurredwithotherdrugsinthisclass,butnotwiththestudydrug InmostcasesthedeterminationdoesnotpauseaparticularchallengeandtheSponsorcanimmediatelyinitiatethecollectionofadditionalinformationregardingtheAEandpreparetheexpeditereporting.However,itmayhappenthatthecaseiscomplexandneedstobereviewedbyanindependentcommittee(SafetyMonitoringCommitteeorClinicalEventAdjudicationCommittee).Insuchacase,itisimperativethatasystembeinplaceallowingforspeedyreviewanddocumentationoftheCommittee’sopinion.SoftwareplatformssuchasthoseusedforClinicalEndpointAdjudicationcanbeagoodsolutionastheyincorporateallthenecessarymechanisms,arecompliantwithregulationsandofferfeaturessuchasautomatedAuditTrailandRecordRetentioncapabilities.Ifsuchaplatformisalreadyinplace,itistheidealtoolforaSUSARdetermination.Thispossibilityshouldbeconsideredwhentakingthedecisionwhethertosetupornotanelectronicendpointadjudicationsystemforaclinicaltrial.    __________________________________________________________ 1PresentationbyYuliyaYasinskaya,MD,MedicalOfficer,CenterforDrugEvaluationandResearch(CDER) 2ClinicalTrialSafetyReportingrequirements,SMEinfoday20Mar2017.PresentedbySophiaMylona,Clinical&Non-clinicalCompliance,EuropeanMedicinesAgency 321CFR312.32(a) DOWNLOADNOWTHEFREEENDPOINTADJUDICATIONHANDBOOK TheCompleteManual/ReferenceBook(34pages)withallthetopicsrelatedtotheIndependentEndpointAdjudicationCommitteesManagement Archives 2022 2021 2020 2019 2018 2017 2016 2015 2014 Tags BICR Blockchain CDISC CentralEndpointCommitteeCEA CentralEventCommittee-CEC ClinicalEventCommittee-CEC DICOMImaging MedicalImagesAdjudication MedidataRave OracleArgus RealTimeAdjudication eAdjudication®SolutionDescription DOWNLOADNOW RequestaDemooftheeAdjudication®SoftwareSolutionWeareEU-GDPRcompliant:YourDatawillneverbeusedimproperly We’lluseyourpersonaldatatocontactyouandfollowyourrequest. ByclickingthesendbuttonyouagreewithourPrivacyPolicy. NOTE:Wewillcontactyou,regardingthisrequest,totheprovidedemailaddress. EventAdjudication CharterGuidebook FreeDownload DOWNLOAD↓ Previous Next WhyAdjudicateAdverseEventsofSpecialInterest(AESI)? Adverseeventsofspecialinteresthaveemergedovertheyearsasoneofthemostcommonfieldsofstudyoflate-stageclinicaltrials.  READMORE HowEthical’seAdjudication®supportssuccessfulendpointadjudication Let’sreviewthesoftware-integratedsix-stepprocessthatsupportsendpointadjudicationperformance. READMORE ClinicalTrialEndpointAdjudication:RolesandResponsibilities linicalresearchprofessionalsaremanningtheadjudicationsystemsandspecificSOPsgovernthewholeprocess.Herearethemainrolesandtheirrespectiveresponsibilities. READMORE 1 2 3