SOP-MS-06-F-01-附件1-臨床試驗(yàn)總結(jié)報(bào)告核查清單

SOP-MS-06Version1.0/2021.6.1 Confidential Page:PAGE1ofNUMPAGES6臨床試驗(yàn)總結(jié)報(bào)告核查清單

ClinicalStudyReportQCChecklist方案號(hào)ProtocolNo.:總結(jié)報(bào)告版本日期CSRVersion/Date研究題目StudyTitle:起草人Draftedby:內(nèi)容

Items審核團(tuán)隊(duì)Reviewteam*是否符合要求？Whethermeettherequirements?PMSADM是Yes不適用/否，請(qǐng)備注NA/No,providecomments版本

Version版本號(hào)和日期

Versionanddate(Version_/date)X首頁(yè)

TitlePage.研究題目

StudytitleX方案編號(hào)ProtocolnumberX試驗(yàn)起始/完成日期Dateofenrollment/completedX申辦方信息SponsorinformationX主要研究者和研究中心PrincipalinvestigatorandstudysiteX統(tǒng)計(jì)學(xué)負(fù)責(zé)人和統(tǒng)計(jì)單位StatisticianandstatisticalsiteX報(bào)告日期ReportdateX原始資料保存地點(diǎn)SourcedatastorageX摘要SynopsisX研究藥物名稱NameofstudydrugX文獻(xiàn)發(fā)表PublicationX研究主要目的Primaryobjective(s)X研究次要目的Secondaryobjective(s)X研究方法MethodologyX受試者人數(shù)（原計(jì)劃和參與分析的）Numbersofpatients(plannedandanalyzed)X病例選擇（入選標(biāo)準(zhǔn)、排除標(biāo)準(zhǔn)）Selectionofsubjects(inclusioncriteria,exclusioncriteria)X研究藥物信息（劑量，批號(hào)，用法用量）Studydrug(s)information(dose,batchnumber,modeofadministration)X主要療效終點(diǎn)PrimaryefficacyendpointX次要療效終點(diǎn)Secondaryefficacyendpoint(s)X安全性分析SafetyevaluationX統(tǒng)計(jì)方法StatisticalmethodsX研究概況StudysummaryX研究結(jié)論StudyconclusionX報(bào)告日期DateofreportX基本資料

BasicInformation機(jī)構(gòu)審核委員或倫理委員會(huì)InstitutionalreviewboardorethicscommitteeX研究的倫理EthicalconductofthestudyX知情同意InformedconsentX研究中心和研究者名單StudysitesandinvestigatorlistX監(jiān)查單位MonitoringunitX數(shù)據(jù)管理單位DatamanagementunitX統(tǒng)計(jì)分析單位StatisticalanalysisunitX申辦單位SponsorX縮略語(yǔ)和術(shù)語(yǔ)定義Abbreviationsanddefinitionofterms縮略語(yǔ)表和術(shù)語(yǔ)定義ListofabbreviationsanddefinitionoftermsX前言Introduction研究藥物的開(kāi)發(fā)及與之相關(guān)的試驗(yàn)重要特征Developingofthestudydrug(s)andrelatedcriticalfeaturesofthestudyX制定方案中的指導(dǎo)原則AnyguidelinesforthedevelopmentoftheprotocolX申辦者與管理機(jī)構(gòu)之間的有關(guān)試驗(yàn)的協(xié)議或會(huì)議Anyotheragreements/meetingsbetweenthesponsorandregulatoryauthoritiesX試驗(yàn)?zāi)康腟tudyObjectives主要目的Primaryobjective(s)X次要目的Secondaryobjective(s)X試驗(yàn)管理Studymanagement研究人員結(jié)構(gòu)和GCP實(shí)施StudystructureandGCPconductionX試驗(yàn)設(shè)計(jì)StudyDesign與終版方案保持一致BeconsistentwiththefinalprotocolX試驗(yàn)總體設(shè)計(jì)StudyoveralldesignX研究流程圖StudyflowchartX試驗(yàn)設(shè)計(jì)討論DiscussionofstudydesignX研究對(duì)象的選擇SelectionofstudypopulationX研究藥物信息Studydrug(s)informationX隨機(jī)分組方法RandomizedgroupingmethodX盲法和緊急揭盲BlindingandunveilofblindingX既往和目前伴隨治療PriorandconcomitanttherapyX治療依從性TreatmentcomplianceX主要療效終點(diǎn)PrimaryefficacyendpointX次要療效終點(diǎn)Secondaryefficacyendpoint(s)X安全性終點(diǎn)SafetyendpointsX數(shù)據(jù)質(zhì)量保證DataqualityassuranceX統(tǒng)計(jì)方法（與終版統(tǒng)計(jì)分析計(jì)劃一致）Statisticalmethods(beinlinewiththefinialSAP)X樣本量確定DeterminationofsamplesizeX試驗(yàn)進(jìn)行中方案或統(tǒng)計(jì)分析計(jì)劃的修改ChangesintheconductofthestudyorplannedanalysesX期中分析InterimAnalysesX結(jié)果Results受試者描述Descriptionofsubjects方案違背Protocoldeviation數(shù)據(jù)集分析Datasetsanalyzed人口學(xué)資料Demographicinformation生命體征和體格檢查L(zhǎng)ifesignsandphysicalexamination其他基線特征Otherbaselinecharacteristics依從性Compliance試驗(yàn)期間合并用藥Concomitantmedicationduringthestudy主要療效分析Primaryefficacyanalysis次要療效分析Secondaryefficacyanalysis療效小結(jié)Efficacyconclusions安全分析集Safetyanalysissets藥物暴露量Extentofexposure不良事件分析Adverseeventsanalysis不良反應(yīng)分析Adversereactionsanalysis重要不良事件分析Importantadverseeventsanalysis嚴(yán)重不良事件

Seriousadverseevents病例數(shù)NumberofsubjectsX基本信息（CRF號(hào)，年齡等）Basicinformation(CRFnumber,age,etc)X事件描述DescriptionofeventsX與研究藥物的關(guān)系RelationshiptothestudydrugX與安全性相關(guān)的實(shí)驗(yàn)室檢查Clinicallaboratoryevaluationrelatedtosafety生命體征Vitalsigns體格檢查Physicalfindings與安全性有關(guān)的其他觀察數(shù)據(jù)Otherobservationsrelatedtosafety安全性小結(jié)Safetyconclusions討論Discussion結(jié)論Overallconclusions相關(guān)的圖表需與終版SAR/TFL一致Relatedtables,chartsanddiagramsshouldbeconsistentwiththefinalSAR/TFL.研究結(jié)論需與終版SAR一致TheresultsshouldbeinlinewiththefinalSAR.其他Others參考文獻(xiàn)ReferencelistX附件AppendicesX總結(jié)報(bào)告簽署頁(yè)ReportsignaturepagesX頁(yè)眉和頁(yè)腳PageheaderandfooterX排版TypesettingX*Note:ReviewteamshouldincludemanagerofScientificAffairsDepartment,MedicalWriter(MW),projectmanager(PM),statistician(SA)anddatamanager(DM).ManagerofScientificAffairsDepar