8药物临床期间SAE严重不良事件报告表-中英文对照版

严重不良事件报告表（SAE）新药临床研究批准文号：编号：报告类型□首次报告□随访报告□总结报告报告时间：年月日医疗机构及专业名称电话申报单位名称电话试验用药品名称中文名称：英文名称：药品注册分类及剂型分类：□中药□化学药□治疗用生物制品□预防用生物制品□其它注册分类：剂型:临床研究分类□Ⅰ期□Ⅱ期□Ⅲ期□Ⅳ期□生物等效性试验□临床验证临床试验适应症：非小细胞肺癌受试者基本情况姓名拼音缩写:出生日期:性别:□男□女身高(cm)：体重(Kg)：合并疾病及治疗：□有□无1.疾病：__________治疗药物：__________用法用量：_______________2.疾病：__________治疗药物：__________用法用量：_______________3.疾病：__________治疗药物：__________用法用量：_______________SAE的医学术语(诊断)SAE情况□死亡______年___月___日□导致住院□延长住院时间□伤残□功能障碍□导致先天畸形□危及生命□其它SAE发生时间：_______年___月___日研究者获知SAE时间：_______年___月___日对试验用药采取的措施□继续用药□减小剂量□药物暂停后又恢复□停用药物SAE转归□症状消失（后遗症□有□无）□症状持续SAE与试验药的关系□肯定有关□可能有关□可能无关□肯定无关□无法判定SAE报道情况国内：□有□无□不详；国外：□有□无□不详SAE发生及处理的详细情况：报告单位名称：报告人职务/职称：报告人签名：SeriousAdverseEventReport(SAE)ApprovalNumberofthenewdrugclinicalresearch：No.：TheReportType□TheFirst-timeReport□TheFollow-upReport□TheSummaryReportReportDate：NameofMedicalInstitutionandProfessionTel:NameoftheApplicationUnitTel:NameOftheExperimentalDrugChineseName:EnglishName:DrugsRegistryClassificationandDosageForm□ChineseMedicine□ChemicalMedicine□BiologicalProductsForTreatment□BiologicalProductsForProphylaxis□Other:__________RegistryClassification:__________DosageForm:__________ClassificationoftheclinicalResearch□StageⅠ□StageⅡ□StageⅢ□StageⅣ□Bioequivalencetest□ClinicalverificationIndicationsoftheClinicalResearch:__________InformationoftheSubjectsNameInitials(Pinyin):DateofBirth:Sex:□M□FHeight(cm)：Weight(Kg)：Anycomorbiditieswithtreatment：□Yes□No1.Disease：__________DrugTreatment：__________DosageandUsage：_______________2.Disease：__________DrugTreatment：__________DosageandUsage：_______________3.Disease：__________DrugTreatment：__________DosageandUsage：_______________MedicaltermsoftheSAE(Diagnosis)OutcomeoftheSAE□DeathDate:__________□hospitalization-initialorprolonged□disability□incapacity□congenitalanomaly□life-threatening□OtherOccurrenceDateoftheSAE:_______WhendotheResearcherfindouttheSAE:__________CorrespondingStepstoSAE□noactionrequired□reducedose□restoreaftersymptomspause□terminateorsuspendthedrugresearchReturnofSAE□DisappearanceofSymptoms（Sequelae□Yes□No）□PersistenceofSymptomsRelationshipofSAEtoResearch□definite(clearlyrelatedtotheresearch)□probable(likelyrelatedtotheresearch)□unlikely(doubtfullyrelatedtotheresearch)□unrelated(clearlynotrelatedtotheresearch)□UnabletojudgeReportedcasedofsimilarSAEDomestic:□Yes□No□UnknownForeign:□Yes□No□UnknownDetailedDescriptionoftheoccurrenceandtreatmentoftheSAE:ReportInstitution:PositionTitleoftheReporter:Reporter’sSignature: