1500 central labratory procedures eurofins en3 mandyen1430中央实验室程序.pptx

KHB-1802

SyneosHealth/ChendguKanghongBiotechnologyChinaMandyYu

EurofinsLabLocationsLancaster,PA.Breda,NetherlandsBangalore,India.Singapore.Shanghai,China

AgendaImportantinformationMaterialsandsuppliesSampleCollectionandProcessingShippingReportingSiteSupport

MaterialsandSupplies

InitialSupplyINVESTIGATORLABORATORYMANUALFlowChartSampleprocessingandhandlinginstructionsStartbatchLabkits(visit-specific)AncillarySuppliesEgAirwaybills,frozenshippers)INVESTIGATORLABORATORYMANUALLabManualGeneralInstructionLMStudySpecificLMCourierPackingShippinginstructionsResupplyformFetchSiteUserGuide

KitandAdditionalSuPpliesKitsIncludedintheStudyKitA–Usefor:-Visit1(Screening)-Visit26-EarlyTermination-UnscheduledsafetyvisitBulkMaterialsUrineCupsPregnancyTestsOtherMaterialsandDocumentationPackingmaterials(kitboxisambientshipper)InvestigatorLaboratoryManual–GeneralInstructionsStudySpecificSampleProcessingFlowchartCourierInstructions-TNTRe-supplyformsPleasenoteKitBandCwillnotbeapplicabletothisregion.Pleaseignorementionofthisinlabmanualandflowchart.

InitialsupplySiteInformation(SCO)10BusinessdaysShippingTimedependsonlocationPleasetakeintoaccountpublicholidaysEconomycourierserviceisdefault.Expresscourierserviceavailableatextracost.

ResupplyResupplyForm5BusinessdaysPleasetakeintoaccountpublicholidaysShippingTimedependsonlocationEconomycourierserviceisdefault.Expresscourierserviceavailableatextracost.

KitResupplyUseoldestkitsfirstMonitortheinventorylevelandnotetheexpirydates.Feeof150$/€forurgentordersShippingtimedependsonlocation/customsclearance/proformainvoiceapproval.

SampleCollectionandProcessing

Visitschedule

Visitschedule(cont’d)

Visitschedule(cont’d)1.≤14dayspriortofirstdoseofstudymedication.2.±7days3.PKandImmunogenicitytesting