Clinical Trail Procedure （英文版）临床评估控制程序.docx

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1、QUA1ITYMANAGEMENTSYSTEMPROCEDUREC1inica1Trai1ProcedureContentsSNTextPage1.0Purpose22.0Scope23.0FormsandAttachments24.0References25.0AbbreviationsandDenitions26.0Responsibi1ities27.0SafetyPrecautions38.0C1inica1Sites39.0TestingRequirements410.0DocumentationMaintenance411.0Fina1Report41.0PurposeThepur

2、poseofthisSOPistodefinetheprocedureforconductingc1inica1tria1sthatinvo1vestheparticipationofhumansubjects.2.0ScopeThisprocedureisapp1icab1etoa11personne1invo1vedinc1inica1tria1sconductedat1YSUNBiotech(Hangzhou)Co.,1TD.3.0FormsandAttachmentsAttachment 1 C1inica1StudyProtoco1-Samp1eAttachment 2 Specim

3、enProcurementOut1ine-Samp1e4.0ReferencesBSEN540:1993C1inica1InvestigationofMedica1DevicesforHumanSubjectsBSEN13612:2(X)2PerformanceEva1uationofInVitroDiagnosticMedica1DevicesENISO14155-1:2003C1inica1InvestigationofMedica1DevicesforHumanSubjectsQP()8()DesignContro1ProcedureQR220Vigi1anceProcedure5.0A

4、bbreviationsandDefinitionsCSC1inica1StudyCTSEuropeanUnionsCommonTechnica1SpecificationsMDRMedica1DeviceReportGCPGoodC1inica1PracticeIVDIn-VitroDiagnosticR&DResearch&Deve1opmentInt,1RAInternationa1Regu1atoryAffairsP1/CRCProject1eaderZC1inica1ResearchCoordinatorQAQua1ityAssurance6.0Responsibi1ities6.1

5、 InitiatoroftheDocumentInfIRArepresentativeisresponsib1eforinitiatingchangestothisprocedure.6.2 Approva1ofChangestotheProcedureTheQua1ityAssuranceManagersha11approvethisprocedure.6.3 NotificationofChangestothisProcedureAfterapprova1,theDocumentContro1Coordinatorsha11notifya11areamanagementwhenthedoc

6、umenthasbeenre1eased.6.4 ExecutionTheInfIRA,R&D,Marketingrepresentativeordesigneeisresponsib1efortheexecutionofthisdocument.6.4.1 Areamanagementisresponsib1eforprovidingadequatetrainingbasedonthetrainingmatrix.6.4.2 TheP1/CRCisresponsib1etoensurethattria1sareconductedanddataaregenerated,recorded,and

7、reportedincomp1iancewiththeprotoco1andapp1icab1eregu1atoryrequirements.6.4.3 TheP1/CRCisresponsib1eforsecuringagreementfrominvo1vedpartiestoensureaccesstoa11tria1re1atedsites,sourcedata,andreportsforthepurposeofmonitoringandauditingby1YSUNbioandregu1atoryauthorities.6.4.4 TheP1/CRCisresponsib1eforap

8、p1yingqua1itycontro1ateachstageofthec1inica1tria1toensurethata11recordsanddataarere1iab1eandhavebeenprocessedcorrect1y.6.4.5 TheP1/CRCisresponsib1etosubmitifapp1icab1eanyrequiredapp1icationstotheappropriateauthoritiesforreview,acceptanceand/orpermissiontobeginac1inica1tria1.Anynotification/submissio

9、nshou1dbedatedandcontainsufficientinformationtoidentifytheprotoco1andapprova1oftheinformedconsentform.6.4.6 TheP1/CRCmonitorsthestatusofthec1inica1studytoensuretheteamisprogressingtowardthecomp1etionoftheactivity.6.4.7 TheP1/CRCisresponsib1eforprioritizingandschedu1ingtheactivitiesneededtoreduceore1

10、iminatethepotentia1adverseevents.6.4.8 TheP1/CRCisresponsib1eforensuringthata11approvedc1inica1studyforms,protoco1s,areaccurate1ycomp1eted.(SeeAttachments).6.7QA6.7.1 QAisresponsib1eformaintainingthec1inica1studyrecords.7.1 SafetyPrecautions1YSUNis1iab1etoa11theparticipantsonbodyinjuriescausedbythec

11、1inica1study.Therearenoothersafetyprecautionsassociatedwiththisprocedure.7.2 C1inica1Sites8.1 C1inica1sitesarese1ectedbythec1inica1studyteam.8.2 C1inica1sitesmustmeeta11regu1atoryrequirements.8.3 Whendeterminingthe1ocationofwherethec1inica1tria1swi11beconducted,theethnicityofthepopu1ationmustbeconsi

12、deredtoensurethepopu1ationsamp1ingisequiva1enttothepopu1ationswheretheproductwi11bedistributed.Itmustbedeterminedifthepopu1ationse1ectedisrepresentativeoftheuserpopu1ation.C1inica1studysitesshou1dbese1ectedbasedonpopu1ationthetestisintendedforanda1sotosatisfyCTSrequirementsforCEmarkedproducts.9.0Tes

13、tingRequirements9.1 Thetestingrequirementsforeachprojectmayvarydependingontheproduct/productc1assification.9.2 Thec1inica1dataobtainedfromthec1inica1tria1wi11beana1yzedthroughappropriatestatistica1ana1ysissoftware.10.0DocumentationofCommunicationI().1Oncethestudyhasconc1uded,theprotoco1sandotherasso

14、ciatedrecordswi11besubmittedtoDocumentCenterformaintenance.Recordswi11bemaintainedforat1east2yearsfromwhenthec1inica1tria1hasbeencomp1eted,terminatedorfromthedatethatmarketapprova1hasbeenobtained.11.0Fina1ReportI11AFina1reportsha11begenerateda1theconc1usionofthestudy.11.2 TheFina1Reportsha11summarizethedataandstateconc1usionsfromthestudy.11.3 Theconc1usionsha11specifica11ystateiftheproductis“safandeffectivefbrtheintendeduses.文件修改履历DocumentHistorySummary修改后版本或页码修改号UpdatedVersionOrPageRevision更改单编号DCRRef更改概述SummaryofChanges生效日期EffectiveDa1e