medical-incident-report-form
CE警戒系统控制程序
9.6 CE警戒系统控制程序1目的：对所有报告的事故进行评估，并发布可能有助于防止同类事故的重复发生或减轻事故影响和后果的信息，改善对病人或使用者的安全与健康的保护。
2适用范围：本程序适用于欧洲共同体和欧洲经济区内发生的医疗器械质量事故，这类医疗器械为：带有CE标志的产品；带有CE标志的产品在欧洲国家以外的销售；无CE标志的产品、但这类事故导致带有CE标志产品采取纠正措施。
3职责3.1欧洲授权代表：收到事故报告后应及时与制造商及主管当局联系，及时把客户的抱怨和事故报告传递给制造商，并负责保持产品销售记录。
3.2制造商3.2.1外贸部：负责收集已发生的事故信息及与产品有关的所有信息，同时将信息反馈到各部门，将公司对事故所采取的措施传递给欧洲授权代表。
3.2.2管理者代表：负责确认有效的事故处理文档，以便外贸部及时传递给服务机构、欧洲授权代表。
4工作程序4.1 管理者代表负责对事故报告信息进行分析，会同企管部、品管部调查后，确定需要报告主管当局的事项。
4.2 公司在决定某项事故是否需要报告主管当局时，应考虑如下方面因素：事故的类型；是否与公司生产的任何医疗器械有关；事故是否有或可能有因器械或提供的有关器械的信息的缺陷引起的。
FIELD SAFETY CORRECTIVE ACTION (FSCA)：表示制造商采取的减少由器械引起的死亡或严重健康衰退风险的措施。
这种措施应通过Field safety notice来通知。
（详见附录）FIELD SAFETY NOTICE (FSN)：表示制造商（或其代表）就FIELD SAFETY CORRECTIVE ACTION (FSCA)与顾客或用户的沟通。
4.3管理者代表针对事故符合以下特征之一或组合时，应向主管当局报告。
4.3.1导致死亡。
4.3.2导致健康严重受损。
a)严重威胁生命的疾病或损伤。
b)身体功能的永久性损伤怒火身体组织的永久性损伤。
c)需要医疗或外科手术一避免对人体功能或人体的永久性损伤。
SDI 标准与程序手册第6部分：SDI 表单9版本0123说明书
61.1 Scuba Diver Registration FormUse this form for the following:1. Open Water Scuba Diver2. Junior Open Water Scuba Diver3. Advanced Scuba Diver4. Master Scuba Diver5. Rescue Diver6. Specialty (Remember to specify which specialty)When using the student registration form, fax or scan and email to SDI Headquarters; the student cards will be returned in the mail.Students can also be registered through the members’ section of International Training Inc website.When registering on-line the cards will be returned in the mail unless the facility has an in-store certification card printer. When using the in-store certification card printer, certification cards are printed and issued immediately to the students.1.2 General Liability Release and Express Assumption of Risk FormsUse this form to obtain the general liability release and assumption of risk from the students. Make sure to review the contents before starting on a course or specialty to ensure it has been completed and signed – including the signature of a witness.Each course the student participates in requires a separate waiver release.1. SDI General Liability Release and Express Assumption of Risk – forTeaching2. SDI General Liability Release and Express Assumption of Risk - ForGuided Scuba Tours for Certified Divers3. SDI General Liability Release and Express Assumption of Risk - ForGuided Snorkeling Tours4. SDI General Liability Release And Express Assumption of Risk - ForUnguided and Unsupervised Boat Dives for Certified Divers5. International Training General Liability Release and ExpressAssumption of Risk – For non-SCUBA courses6. International Training Notice To The Minor Child’s Natural Guardian1.3 Notice To The Minor Child’s Natural GuardianUse this form when teaching or supervising minors in the US state of Florida. This release is used in conjunction with the appropriate liability release for the specified activity or course.1.4 Specialty Upgrade Form for Assistant Instructors and InstructorsUse this form to file for specialty upgrades.1.5 Open Water Global Referral FormUse this form to when a student is traveling to another facility for the open water certification. The procedure is covered in Part 2 – SDI Diver Standards Section 6 Open Water Scuba Diver Standards.1.6 Solo Release FormUse this form as the Solo Diver Liability Release.1.7 Accident / Incident Report FormUse this form to file information regarding an accident or incident with SDI Headquarters.1.8 Academic Presentation FormUse this form when preparing for the academic portion of a class. An example of its usage can be found in the academic portion of the Open Water Instructor Manual.1.9 In-Water Presentation FormUse this form when preparing for the confined portion of a class. An example of its usage can be found in the in-water portion of the SDI Open Water Scuba Diver Instructor Manual.1.10 Member Update FormUse this form when renewing if a membership or teaching status has lapsed after 2 years not teaching.1.11 Dive Leader ApplicationUse this form to file for Divemaster, Assistant Instructor, and Open Water Scuba Diver Instructor ratings.1.12 Medical Questionnaire and Physicians Sign Off Use this form to obtain medical information for the students. Make sureto review the contents before starting on a course or specialty. Should the student mark yes to any item on the questionnaire, the Guidelines to the Physician and the Physician’s Sign-off page are included in this form.1.13 SDI JR Open Water Upgrade FormUse this form when an individual who was originally certified as an SDI Open Water Scuba Diver, turns 15 and wishes to upgrade to an SDI Open Water Scuba Diver.1.14 SDI Student Record FolderUse this folder to document, and retain, all training records for an SDI Diver.1.15 Divemaster Course ChecklistUse this form to track progress throughout the DM course1.16 Assistant Instructor Course ChecklistUse this form to track progress throughout the AI course1.17 Instructor Development Course (IDC) Instructor Evaluation Course (IEC) checklistUse this form to track progress throughout an Instructor Development Course (IDC) or Instructor Evaluation Course (IEC)1.18 Unique Specialty/Ops Course Application And GuidelinesUse this form to request for a Unique Specialty Instructor Upgrade1.19 Member AgreementAny new member must submit signed Membership Agreement with leadership level registration documents.。
液体外渗不良事件书写记录范文
液体外渗不良事件书写记录范文英文回答：Fluid Extravasation Incident Report Form.Patient Information:Name:Medical Record Number:Date of Birth:Attending Physician:Incident Information:Date and Time of Incident:Location of Incident:Type of Fluid Involved:Volume of Fluid Extravasated:Duration of Extravasation:Assessment:Visual assessment of affected area: Palpation of affected area:Pain level:Temperature of affected area:Capillary refill time:Management:Immediate actions taken:Medications administered:Dressings applied:Other treatments provided:Follow-Up:Date and time of next follow-up:Expected outcome:Instructions for patient care:Documentation:Photographs of affected area (if available): Copies of relevant medical records:Incident Investigation:Investigation findings:Root cause analysis:Recommended corrective actions:Additional Notes:Definitions: Fluid extravasation is the unintended infiltration of fluid (e.g., IV fluids, medications) into the surrounding tissues.Complications: Fluid extravasation can lead to pain, tissue damage, compartment syndrome, and infection.Prevention: Proper IV insertion and monitoring techniques are essential to prevent fluid extravasation.中文回答：液体外渗不良事件书写记录范文。
临床试验常见英文缩写
临床试验常见英文缩写ADR（Adverse drug reaction）不良反应AE（Adverse event）不良事件SAE（Serious Adverse Event）严重不良事件CRF（Case report form/case record form）病例报告表CRO（Contract research organization）合同研究组织EC（Ethics Committee）伦理委员会GCP（Good clinical practice）药品临床试验管理规范EDC（Electronic data capture）电子数据采集IB（Investigator's Brochure）研究者手册ND (Not Done) 未做NA (Not Applicable) 不适用UK (Unknown) 未知PI（Principal investigator ）主要研究者Sub-I(Sub-investigator) 助理研究者QA(Quality assurance) 质量保证QC(Quality control) 质量控制SDV（Source data verification）原始资料核对SD（Source data）原始数据SD(Source document ) 原始文件SFDA 国家食品药品监督管理局SOP(Standard operating procedure) 标准操作规程IRB 机构审查委员会ICF(Informed Consent Form) 知情同意书TMF（trial master file）研究管理文件夹临床试验常见英文单词A•Active control ,AC 阳性对照，活性对照阳性对照，活性对照•Adverse drug reaction ,ADR 药物不良反应药物不良反应•Adverse event ,AE 不良事件•Approval 批准•Assistant investigator 助理研究者•Audit 稽查•Audit report 稽查报告•Auditor 稽查员B•Bias 偏性，偏倚•Blank control 空白对照•Blinding/masking 盲法，设盲•Block 层C•Case history 病历•Case report form/case record form ,CRF 病例报告表，病例记录表•Clinical study 临床研究•Clinical trial 临床试验•Clinical trial application ,CTA 临床试验申请•Clinical trial exemption ,CTX 临床试验免责•Clinical trial protocol ,CTP 临床试验方案•Clinical trial/study report 临床试验报告•COA(药品检测报告)•Co-investigator 合作研究者•Comparison 对照•Compliance 依从性•Computer-assisted trial design ,CATD 计算机辅助试验设计•Contract research organization ,CRO 合同研究组织•Contract/agreement 协议/合同•Coordinating committee 协调委员会•Coordinating investigator 协调研究者•Cross-over study 交叉研究•Cure 痊愈•CTRB 临床试验文件夹D•Documentation 记录/文件•Dose-reaction relation 剂量—反应关系•Double blinding 双盲•Double dummy technique 双盲双模拟技术E•Electronic data capture ,EDC 电子数据采集系统•Electronic data processing ,EDP 电子数据处理系统•Endpoint criteria/measurement 终点指标•Essential documentation 必需文件•Excellent 显效•Exclusion criteria 排除标准F•Failure 无效，失败•Final report 总结报告•Final point 终点•Forced titration 强制滴定G&H•Global 全球•Generic drug 通用名药•Good clinical practice ,GCP 药物临床试验质量管理规定•Good manufacture practice ,GMP 药品生产质量管理规范•Good non-clinical laboratory practice ,GLP 药物非临床研究质量管理规范•Health economic evaluation ,HEV 健康经济学评价•Hypothesis testing 假设检验I•Improvement 好转•Inclusion criteria 入选标准•Independent ethics committee ,IEE 独立伦理委员会•Information gathering 信息收集•Informed consent form ,ICF 知情同意书•Informed consent ,IC 知情同意•Initial meeting 启动会议•Inspection 视察/检查•Institution inspection 机构检查•Institutional review board ,IBR 机构审查委员会•Intention to treat 意向治疗•Interactive voice response system ,IVRS 互动式语音应答系统•International Conference on Harmonization ,ICH 国际协调会议•Investigational new drug ,IND 新药临床研究•Investigational product 试验药物•Investigator 研究者•Investigator’s brochure ,IB 研究者手册L•Local 局部M&N•Marketing approval/authorization 上市许可证•Matched pair 匹配配对•Monitor 监查员•Monitoring 监查•Monitoring report 监查报告•Multi-center trial 多中心试验•New chemical entity ,NCE 新化学实体•New drug application ,NDA 新药申请•Non-clinical study 非临床研究O•Obedience 依从性•Optional titration 随意滴定•Original medical record 原始医疗记录•Outcome 结果•Outcome assessment 结果指标评价•Outcome measurement 结果指标P•Patient file 病人指标•Patient history 病历•Placebo 安慰剂•Placebo control 安慰剂对照•Preclinical study 临床前研究•Principle investigator ,PI 主要研究者•Product license ,PL 产品许可证•Protocol 试验方案•Protocol amendment 方案补正Q&R•Quality assurance ,QA 质量保证•Quality assurance unit ,QAU 质量保证部门•Quality control ,QC 质量控制•Randomization 随机•Regulatory authorities ,RA 监督管理部门•Replication 可重复•Run in 准备期S•Sample size 样本量，样本大小•Serious adverse event ,SAE 严重不良事件•Serious adverse reaction ,SAR 严重不良反应•Seriousness 严重性•Severity 严重程度•Simple randomization 简单随机•Single blinding 单盲•Site audit 试验机构稽查•Source data ,SD 原始数据•Source data verification ,SDV 原始数据核准•Source document ,SD 原始文件•Sponsor 申办者•Sponsor-investigator 申办研究者•Standard operating procedure ,SOP 标准操作规程•Statistical analysis plan ,SAP 统计分析计划•Study audit 研究稽查•Subgroup 亚组•Sub-investigator 助理研究者•Subject 受试者•Subject diary 受试者日记•Subject enrollment 受试者入选•Subject enrollment log 受试者入选表•Subject identification code ,SIC 受试者识别代码•Subject recruitment 受试者招募•Subject screening log 受试者筛选表•System audit 系统稽查T&U•Trial error 试验误差•Trial master file 试验总档案•Trial objective 试验目的•Trial site 试验场所•Triple blinding 三盲•Unblinding 破盲•Unexpected adverse event ,UAE 预料外不良事件V&W•Variability 变异•Visual analogy scale 直观类比打分法•Vulnerable subject 弱势受试者•Wash-out 清洗期•Well-being 福利，健康EDC 系统常见英文缩写•1.SCR (screening) 筛选•2.DOV (date of visit) 访视第一天•3.ELIG ( ELIGIBILITY ) 入排合格•4.DEM ( DEMOGRAPHY )人口统计学•5.MEDSX (medical history) 既往史•MHX1 : CANCER RELATED CURRENT MEDICAL CONDITIONS 该肿瘤手术史及肿瘤相关症状•MHX2 : NON-CANCER RELATED MEDICAL CONDITIONS•与该肿瘤无关的病史•6.VS /VITALS ( VITAL SIGNS ) 生命体征•7.ECOG/PS 体能评分note：后面具体讲解•8. ECG : 12-LEAD ECG 心电图•9. ECHO ( ECHOCARDIOGRAM ) 超声心动图•10. HAEMA ( LOCAL LABORATORY –HAEMATOLOGY )血常规•11. CHEM ( LOCAL LABORATORY –CLINICAL CHEMISTRY )血生化•12. URIN ( urine ) 尿常规•13. C1 ( Cycle1 ) 第一周期•14. WD : End of Therapy/DISCONTINUATION 结束治疗(停止用药)•15. FU ( Follow-up ) 随访•16.CMED( CONCOMITANT MEDICATIONS ) 伴随药物•17. AE ( NON-SERIOUS ADVERSE EVENTS ) 不良事件•18. SAE ( SERIOUS ADVERSE EVENTS ) 严重不良事件•19. EOS( End of Study ) 结束研究：肿瘤以病人死亡事件为准•20. UNS ( Unscheduled Visit ) 不预期访问•21.ND (Not Done) 未做•22. NA (Not Applicable) 不适用• (Unknown) 未知临床试验常见语句描述一. 临床试验过程描述1）一般描述：1. Subject was diagnosed with XX in September, 2010, and had XX surgery in December, 2010.患者于2010 年9 月确诊XX 疾病，于2010 年12 月行XX 术。
MEDDEVrev附录中英文
附件3 制造商向国家主管当局提交报告格式表ANNEX 3 REPORT FORM FOR MANUFACTURER’S TO THE NATIONAL COMPETENTAUTHORITYManufacturer’s Incident Report制造商事故报告医疗器械警戒系统本人保证就本人所掌握的知识范围,上述信息是正确的。
I affirm that the information given above is correct to the best of my knowledge.签名Signature姓名Name：城市City:日期Date:Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the National Competent Authority that the content of this report is complete or accurate, that the medical device(S) caused or contributed to the alleged death or deterioration the state of the health of any person.本报告的提交本身并不代表制造商和／或其授权代表或国家主管当局对本报告的内容完整或准确的结论，也不代表所列医疗器械的任何错误和／或医疗器械引起或促成了宣称的任何人的死亡或其健康六况的严重损坏。
附录4 欧洲市场安全纠正措施ANNEX 4 EUROPEAN FIELD SAFETY CORRECTIVE ACTION REPORT FORM医疗器械警戒系统(MEDDEV 2.12/1 rev 5)[键入文字]本人保证就本人所掌握的知识范围,上述信息是正确的。
医疗器械警戒系统指南(MEDDEV第8版) 附录3和4_中英文
附件3 制造商向国家主管当局提交报告格式表ANNEX 3 REPORT FORM FOR MANUFACTURER’S TO THE NATIONAL COMPETENTAUTHORITYManufacturer’s Incident Report制造商事故报告医疗器械警戒系统本人保证就本人所掌握的知识范围,上述信息是正确的。
I affirm that the information given above is correct to the best of my knowledge.签名Signature姓名Name：城市City:日期Date:Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the National Competent Authority that the content of this report is complete or accurate, that the medical device(S) caused or contributed to the alleged death or deterioration the state of the health of any person.本报告的提交本身并不代表制造商和／或其授权代表或国家主管当局对本报告的内容完整或准确的结论，也不代表所列医疗器械的任何错误和／或医疗器械引起或促成了宣称的任何人的死亡或其健康六况的严重损坏。
附录4 欧洲市场安全纠正措施ANNEX 4 EUROPEAN FIELD SAFETY CORRECTIVE ACTION REPORT FORM医疗器械警戒系统(MEDDEV 2.12/1 rev 8)本人保证就本人所掌握的知识范围,上述信息是正确的。
临床试验常见英文缩写
临床试验常见英文缩写ADR（Adverse drug reaction）不良反应AE（Adverse event）不良事件SAE（Serious Adverse Event）严重不良事件CRF（Case report form/case record form）病例报告表CRO（Contract research organization）合同研究组织EC（Ethics Committee）伦理委员会GCP（Good clinical practice）药品临床试验管理规范EDC（Electronic data capture）电子数据采集IB（Investigator's Brochure）研究者手册ND (Not Done) 未做NA (Not Applicable) 不适用UK (Unknown) 未知PI（Principal investigator ）主要研究者Sub-I(Sub-investigator) 助理研究者QA(Quality assurance) 质量保证QC(Quality control) 质量控制SDV（Source data verification）原始资料核对SD（Source data）原始数据SD(Source document ) 原始文件SFDA 国家食品药品监督管理局SOP(Standard operating procedure) 标准操作规程IRB 机构审查委员会ICF(Informed Consent Form) 知情同意书TMF（trial master file）研究管理文件夹临床试验常见英文单词A•Active control ,AC 阳性对照，活性对照阳性对照，活性对照•Adverse drug reaction ,ADR 药物不良反应药物不良反应•Adverse event ,AE 不良事件•Approval 批准•Assistant investigator 助理研究者•Audit 稽查•Audit report 稽查报告•Auditor 稽查员B•Bias 偏性，偏倚•Blank control 空白对照•Blinding/masking 盲法，设盲•Block 层C•Case history 病历•Case report form/case record form ,CRF 病例报告表，病例记录表•Clinical study 临床研究•Clinical trial 临床试验•Clinical trial application ,CTA 临床试验申请•Clinical trial exemption ,CTX 临床试验免责•Clinical trial protocol ,CTP 临床试验方案•Clinical trial/study report 临床试验报告•COA(药品检测报告)•Co-investigator 合作研究者•Comparison 对照•Compliance 依从性•Computer-assisted trial design ,CATD 计算机辅助试验设计•Contract research organization ,CRO 合同研究组织•Contract/agreement 协议/合同•Coordinating committee 协调委员会•Coordinating investigator 协调研究者•Cross-over study 交叉研究•Cure 痊愈•CTRB 临床试验文件夹D•Documentation 记录/文件•Dose-reaction relation 剂量—反应关系•Double blinding 双盲•Double dummy technique 双盲双模拟技术E•Electronic data capture ,EDC 电子数据采集系统•Electronic data processing ,EDP 电子数据处理系统•Endpoint criteria/measurement 终点指标•Essential documentation 必需文件•Excellent 显效•Exclusion criteria 排除标准F•Failure 无效，失败•Final report 总结报告•Final point 终点•Forced titration 强制滴定G&H•Global 全球•Generic drug 通用名药•Good clinical practice ,GCP 药物临床试验质量管理规定•Good manufacture practice ,GMP 药品生产质量管理规范•Good non-clinical laboratory practice ,GLP 药物非临床研究质量管理规范•Health economic evaluation ,HEV 健康经济学评价•Hypothesis testing 假设检验I•Improvement 好转•Inclusion criteria 入选标准•Independent ethics committee ,IEE 独立伦理委员会•Information gathering 信息收集•Informed consent form ,ICF 知情同意书•Informed consent ,IC 知情同意•Initial meeting 启动会议•Inspection 视察/检查•Institution inspection 机构检查•Institutional review board ,IBR 机构审查委员会•Intention to treat 意向治疗•Interactive voice response system ,IVRS 互动式语音应答系统•International Conference on Harmonization ,ICH 国际协调会议•Investigational new drug ,IND 新药临床研究•Investigational product 试验药物•Investigator 研究者•Investigator’s brochure ,IB 研究者手册L•Local 局部M&N•Marketing approval/authorization 上市许可证•Matched pair 匹配配对•Monitor 监查员•Monitoring 监查•Monitoring report 监查报告•Multi-center trial 多中心试验•New chemical entity ,NCE 新化学实体•New drug application ,NDA 新药申请•Non-clinical study 非临床研究O•Obedience 依从性•Optional titration 随意滴定•Original medical record 原始医疗记录•Outcome 结果•Outcome assessment 结果指标评价•Outcome measurement 结果指标P•Patient file 病人指标•Patient history 病历•Placebo 安慰剂•Placebo control 安慰剂对照•Preclinical study 临床前研究•Principle investigator ,PI 主要研究者•Product license ,PL 产品许可证•Protocol 试验方案•Protocol amendment 方案补正Q&R•Quality assurance ,QA 质量保证•Quality assurance unit ,QAU 质量保证部门•Quality control ,QC 质量控制•Randomization 随机•Regulatory authorities ,RA 监督管理部门•Replication 可重复•Run in 准备期S•Sample size 样本量，样本大小•Serious adverse event ,SAE 严重不良事件•Serious adverse reaction ,SAR 严重不良反应•Seriousness 严重性•Severity 严重程度•Simple randomization 简单随机•Single blinding 单盲•Site audit 试验机构稽查•Source data ,SD 原始数据•Source data verification ,SDV 原始数据核准•Source document ,SD 原始文件•Sponsor 申办者•Sponsor-investigator 申办研究者•Standard operating procedure ,SOP 标准操作规程•Statistical analysis plan ,SAP 统计分析计划•Study audit 研究稽查•Subgroup 亚组•Sub-investigator 助理研究者•Subject 受试者•Subject diary 受试者日记•Subject enrollment 受试者入选•Subject enrollment log 受试者入选表•Subject identification code ,SIC 受试者识别代码•Subject recruitment 受试者招募•Subject screening log 受试者筛选表•System audit 系统稽查T&U•Trial error 试验误差•Trial master file 试验总档案•Trial objective 试验目的•Trial site 试验场所•Triple blinding 三盲•Unblinding 破盲•Unexpected adverse event ,UAE 预料外不良事件V&W•Variability 变异•Visual analogy scale 直观类比打分法•Vulnerable subject 弱势受试者•Wash-out 清洗期•Well-being 福利，健康EDC 系统常见英文缩写•1.SCR (screening) 筛选•2.DOV (date of visit) 访视第一天•3.ELIG ( ELIGIBILITY ) 入排合格•4.DEM ( DEMOGRAPHY )人口统计学•5.MEDSX (medical history) 既往史•MHX1 : CANCER RELATED CURRENT MEDICAL CONDITIONS 该肿瘤手术史及肿瘤相关症状•MHX2 : NON-CANCER RELATED MEDICAL CONDITIONS•与该肿瘤无关的病史•6.VS /VITALS ( VITAL SIGNS ) 生命体征•7.ECOG/PS 体能评分note：后面具体讲解•8. ECG : 12-LEAD ECG 心电图•9. ECHO ( ECHOCARDIOGRAM ) 超声心动图•10. HAEMA ( LOCAL LABORATORY –HAEMATOLOGY )血常规•11. CHEM ( LOCAL LABORATORY –CLINICAL CHEMISTRY )血生化•12. URIN ( urine ) 尿常规•13. C1 ( Cycle1 ) 第一周期•14. WD : End of Therapy/DISCONTINUATION 结束治疗(停止用药)•15. FU ( Follow-up ) 随访•16.CMED( CONCOMITANT MEDICATIONS ) 伴随药物•17. AE ( NON-SERIOUS ADVERSE EVENTS ) 不良事件•18. SAE ( SERIOUS ADVERSE EVENTS ) 严重不良事件•19. EOS( End of Study ) 结束研究：肿瘤以病人死亡事件为准•20. UNS ( Unscheduled Visit ) 不预期访问•21.ND (Not Done) 未做•22. NA (Not Applicable) 不适用• (Unknown) 未知临床试验常见语句描述一. 临床试验过程描述1）一般描述：1. Subject was diagnosed with XX in September, 2010, and had XX surgery in December, 2010.患者于2010 年9 月确诊XX 疾病，于2010 年12 月行XX 术。
写一篇填写病人信息的报告单英语作文
写一篇填写病人信息的报告单英语作文全文共6篇示例，供读者参考篇1Filling Out the Patient Form at the Doctor's OfficeHi there! My name is Emma and I'm 10 years old. I recently had to go to the doctor for a check-up before starting 5th grade. My mom took me to our family doctor's office and when we got there, the nice lady at the front desk gave my mom a clipboard with some papers on it. She said it was the patient information form that needed to be filled out before I could see the doctor.The form looked pretty long with lots of boxes and lines to write in. I offered to help my mom fill it out since I'm getting better at reading and writing. She smiled and said, "Sure, that would be great! Let's do it together."First Question: Patient's NameThis one was easy - I wrote down "Emma Thompson" in the boxat the top. The form wanted my full, legal name.Next was: Date of BirthI turned to my mom and asked, "Hey mom, what's my birthday again?" She laughed and told me the date: September 21st, 2012. I carefully wrote that down on the line.Address and Phone NumberFor the address, I wrote down "465 Maple Lane, Oakville." That's where our house is. Then my mom spelled out our home phone number slowly so I could write the numbers correctly in the little boxes.Parent/Guardian NamesI knew this one! I wrote "Jack Thompson" for my dad's name and "Lily Thompson" for my mom's name. The form wanted to know who my parents/guardians were.Emergency ContactMom said to put down "Grandma Sarah" with her phone number, in case they needed to call someone else if my parents couldn't be reached.Primary LanguageThis one seemed silly to me since I clearly speak English, but I wrote "English" anyway.Patient Employment InfoThis section had a bunch of lines for employment details, but I just wrote "Student" for occupation and left the other lines blank. I'm a kid - I don't have a job!Allergy InformationThankfully, I don't have any allergies, so I checked the "No Known Drug Allergies" box.Current MedicationsSame thing - I don't take any medications, so I just wrote "None" on that line.Medical HistoryNow this part was really long with lots of different illness names listed. My mom helped me go through them one-by-one to check if I had ever had any of those sicknesses or conditions. Mostly I just checked "No" beside each one, but she reminded me to check "Yes" for Chicken Pox since I had that when I was 6 years old.Surgical HistoryThis section asked if I had ever had any kind of operation before. I haven't, so I just wrote "No Surgeries" on that line.Family Medical HistoryHere the form wanted to know about medical issues in my family. Mom said to check the boxes for Heart Disease (my grandpa), Hypertension (my aunt), and Diabetes (my uncle). The rest we left blank.Review of SystemsThis was definitely the hardest part! There were all these medical words about different systems in the body like cardiovascular, gastrointestinal, neurological, and I had no idea what half of them meant. Thankfully, my mom is a nurse so she could help me go through each section, ask me the right questions, and check the appropriate boxes.Social HistoryFor this part about social habits, I checked the "No" boxes for things like tobacco, alcohol, and drug use. Obviously I don't do any of that - I'm just a kid! I also checked that I don't exercise really, except for gym class at school.Physical and SignatureFinally, the last section had some blank lines to write down my current height, weight, and blood pressure. But the nurse hadn't measured any of that yet, so we left it blank for now. Thenmy mom signed her signature at the bottom saying all the information was true and complete.Phew, that was a lot of writing and questions! I was really glad my mom was there to help me since some of the medical parts were confusing. But we got it all filled out together.When we turned the form back in to the front desk, the lady smiled and said I had done a great job. She led us back to the patient room to wait for the doctor. While we waited, I felt proud that I was able to help complete my very first medical form. Being 10 years old, I don't go to the doctor too often yet. But I know there will be more forms to fill out as I get older. Now I feel a little more prepared after this experience! Getting practice is important. Maybe someday I'll be a doctor or nurse like my mom and I'll be the one asking patients to fill out the forms. But for today, I was just happy we did it together and I learned something new.篇2Filling Out the Patient FormHospitals and doctors' offices have lots of important papers you have to fill out before they can help you feel better. One of those papers is called the "patient information form" and it asksall kinds of questions about you and your family. Today I'm going to tell you all about filling out that form because it can be kind of confusing, especially for a kid.The first thing the form wants to know is your name. That one is pretty easy - you just write your first and last name, like "John Smith." Although sometimes it also asks for a middle name or initial, so you might have to write "John P. Smith" if your middle name is Paul.Next it asks for your date of birth. That means the day, month and year you were born. I always get confused about how to write the date properly. In America, we put the month first, then the day, then the year. So my birthday on April 21st, 2012 would be written as 04/21/2012. In other countries they put the day first before the month, which seems really weird to me!After your name and birthday, it asks for your gender - whether you are male or female. There's usually a little box you check for "male" or "female." I'm a male, so I check that box.Then the form wants your address - that's the place where you live. You have to write the street number and name first, like "123 Main Street." Next comes the city you live in, then the state (using its 2-letter abbreviation like CA for California), and finallythe zip code which is five numbers that tell where your neighborhood is located.Following the address, there's a few lines for phone numbers. It will say "Home Phone" and you write your house's landline number if you have one. Then there's a line for a "Cell Phone" which is where you put your mom or dad's mobile number. It's important they have a way to call you or your parents in case of an emergency.The next section is all about your parents or guardians. It will have a space to write their names, addresses, phone numbers, and other contact information. You might need to ask your mom or dad for help with filling this part out correctly.After the parent info, the form usually asks about your race or ethnicity. There will be checkboxes for things like "White," "Black," "Asian," "Hispanic/Latino" and more. You just check whichever box matches your family's background. If you're mixed with more than one race, you can check multiple boxes.Another really important part is the medical history section. This is where you tell the doctor if you have any health issues or take any medications. Things like allergies, asthma, diabetes, and other illnesses all get listed here. Your mom or dad can help you remember everything to include. You also have to note everymedication, vitamin, or supplement you take and what it's for. It's okay if you don't know all the specifics, the doctor just wants you to share whatever you can.Next comes the emergency contact section. This is where you provide information about a friend or family member the doctors can call if your parents can't be reached right away in an emergency. It will ask for their name, relation to you (like "aunt" or "uncle"), phone numbers, and address.The last part has to do with your insurance company and policy numbers. This is all the info about whatever health insurance plan covers your medical bills and expenses. Your parents will need to fill this portion out since most kids don't know those details offhand. The insurance company's name, address, policy number, and group number all go in those blanks.Phew, that's a lot of questions! Filling out the whole patient form can be kind of tiring, especially for a kid. But it's really important to answer everything as completely and accurately as you can. That way, the doctors and nurses have all the info they need to take good care of you.If you get stuck on any part of the form, just ask your parents for help. Moms and dads are pros at this kind of paperwork sincethey do it all the time for school, camp, and other activities too. Your doctor should also have staff members available who can walk you through any confusing sections.So don't stress too much about getting everything perfect on the first try. Just do your best, write neatly, and double-check to make sure you didn't miss any important details. Providing good information up front makes the rest of your visit much smoother. Then the doctor can focus on helping you get healthy instead of trying to track down missing forms and documents.Well, I hope this inside look at the patient information form was helpful! Next time you go to the doctor's office or hospital, you'll be a pro at filling it out. Just breathe, take your time, and always ask for assistance if you need it. Before you know it, that stack of paperwork will be complete and you'll be one step closer to feeling better. Isn't that worth a few minutes of form-filling? I think so!篇3Filling Out the Patient FormHi there! My name is Timmy and I'm 10 years old. Today I had to go to the doctor's office for a check-up. When we got there, the nurse at the front desk handed my mom a clipboardwith a bunch of papers on it. She said it was the patient information form that needed to be filled out before I could see the doctor. I thought it would be super boring, but it actually ended up being kind of interesting!The first part asked for my personal information. Things like my full name, date of birth, age, gender, and contact information. That was pretty easy since I know all that stuff. Although I did have to double check how to spell my middle name - it's a weird one!Next up was the section about my parent's or guardian's information. I knew my mom's name and phone number, but I had to ask her how to spell her middle name too. We both had a little laugh about that. Then it asked for her employer and work phone number in case they needed to reach her during the day. I felt like a spy having to get all those secret work details!The part after that was about my home address and phone number. Writing out my full street address always takes forever with all those numbers and street names. I'm just glad I don't have to do it very often. Although I do practice addressing letters and envelopes sometimes which helps.Then there were a few questions about my race, ethnicity, and language preferences. My mom helped me fill that out. Shesaid it's important for the doctors to know that kind of stuff so they can make sure they understand my background and culture. That way they can take better care of me. I never really thought about it like that before.Up next was the emergency contact section. We listed my dad's cell phone number and my aunt's number too, just in case. Having reliable emergency contacts is super important. Especially for kids! You never know what could happen.After that, there were a bunch of medical questions. Things like asking if I had any allergies, current medications, past surgeries or hospitalizations, and medical conditions that run in the family. I don't have any allergies or take any medications, but my grandpa did have to have his appendix out a few years ago. So we made sure to note that.There were also some boxes to check if I had ever had illnesses like chickenpox, measles, mumps or other childhood diseases. Luckily I got my vaccinations for those when I was a baby, so most of those were blank. Although I did get chickenpox when I was 6 before I could get that vaccine. It was not fun at all being so itchy!Then the form asked about my pregnancy history. I'm definitely too young for that! But I guess they have to ask thosetypes of questions for older girls and ladies. My mom just wrote "N/A" which I learned stands for "not applicable."There was a whole section asking about my social habits too. Things like whether I drink alcohol, smoke, or use recreational drugs. As if! I'm way too young for all that unhealthy and illegal stuff. I don't even know any kids my age who do those kinds of things. My mom just checked "no" to all of those.One of the last parts asked about my diet and exercise habits.I don't always eat as many fruits and veggies as I probably should. But I did make sure to mention that I drink lots of milk for strong bones! And I noted that I play soccer, basketball, and baseball to stay active. Exercising and being part of sports teams is really important for keeping kids healthy.The very last section had a bunch of lines for listing any other important information about my health. I talked about how I had a pretty bad asthma attack over winter break after being outside in the cold air too long. And that I sometimes have trouble falling asleep at night. Other than that, I'm a pretty healthy kid!Finally, after filling out allllll those forms, my name got called and I went back to see the doctor. She asked me a few other questions and gave me a check-up. Turns out I grew a couple ofinches since last year! She said as long as I keep eating right, exercising, and getting enough sleep, I should stay growing like a weed.Overall, filling out that patient form was a lot more work than I thought it would be. But now I understand why it's so important for doctors to have all that information. It helps them learn about my background, health history, and lifestyle. That way they can give me the best possible care. I'm sure it will be much easier to fill out next time since I'm an expert form-filler now! Although I really hope I don't have to go back to the doctor again anytime too soon.篇4Filling Out the Patient Form at the Doctor's OfficeHi there! My name is Timmy and I'm 8 years old. Today I had to go to the doctor's office for my annual check-up. I don't really like going to the doctor's because I'm always a little nervous, but my mom says it's important to make sure I'm healthy and growing properly.When we arrived at the doctor's office, the first thing we had to do was check in at the front desk. The friendly lady behind the counter asked my mom for our insurance information and thenhanded her a clipboard with some papers attached. She told my mom to fill out the patient information form while we waited to be called back.The form had a bunch of different sections and boxes to fill in. I looked it over with my mom as she started working on it. The first part asked for my basic personal information like my full name, date of birth, gender, and address. That part was easy since I know all that stuff pretty well. My mom double checked the spelling of my name and street as she wrote it down.Next, the form wanted to know who my parent/guardian was and how to contact them. My mom wrote down her name and her cell phone number. She said it was important they had a way to reach her in case of an emergency or if they needed to ask follow-up questions.After that, there were questions about my medical history. My mom had to think for a minute on some of these. It asked if I had ever been hospitalized or had any major illnesses, injuries or surgeries. Luckily I haven't had anything too serious, but my mom wrote down the time when I got my tonsils out a couple years ago.It also asked if I had any allergies or was currently taking any medications. My mom wrote down that I'm allergic to peanuts,which is why I have an EpiPen with me all the time. There was a box to check if I had asthma, diabetes, or other chronic conditions. We left those blank.There was a whole section dedicated to my immunization records. The form wanted to know what vaccines I had received and when. My mom reference my immunization booklet from my pediatrician to make sure she listed them all out correctly. Things like chickenpox, measles, hepatitis, meningitis, and all those other important shots.One of the final sections asked about my reasons for visiting the doctor today. My mom wrote "Annual well-child check-up" and also mentioned that I had been complaining about some knee pain recently from all the running and playing I do. She wanted the doctor to take a look at that.The last part of the form had a space for insurance information. My mom copied down her insurance ID number and group number from her card. The form also wanted to know my primary care doctor's name, which my mom listed as Dr. Martin.Phew! It seemed like a lot of information to write down, but my mom said it was important for my medical team to have all those details on file. She double checked her work before handing the clipboard back to the receptionist.Not long after, a friendly nurse came out and called my name. She led me and my mom back to one of the examination rooms to wait for the doctor. I hoped I wouldn't need any shots at this visit!Overall, filling out the patient form wasn't too bad. It definitely covered a lot of ground, but I could see why the doctor would want to have answers to all those questions. Things like my medical history, allergies, medications, and insurance are all important stuff they need to know to take good care of me. I'll just have to remember all those details for the next time I need to complete one!篇5My Day at the Doctor's OfficeLast week, I had to go to the doctor's office for my annual checkup. I don't really like going to the doctor's because it can be kind of scary and boring. But my mom says it's really important to go every year to make sure I am healthy and growing properly.When we arrived at the doctor's office, the first thing we had to do was check in at the front desk. The lady behind the counter asked my mom for our insurance information. I'm not really surewhat insurance is, but I know it's some kind of thing that helps pay for doctor's visits.After checking in, we went to sit in the waiting room. The waiting room had a lot of chairs and some kids' toys and books to keep us busy. I tried to read one of the books, but it was kind of boring. My little brother ended up making a huge mess throwing all the toys around. Oops!Finally, after what felt like forever, a nurse called my name. She led us back into one of the patient rooms. The room had an exam table that was kinda like a bed but harder. It also had a scale to weigh me, and some chairs for me and my mom to sit in.The first thing the nurse did was take my temperature by sticking a thermometer in my mouth. She said I didn't have a fever, which is good I guess. Then she used this weird squeezy thing to take my blood pressure. I'm not totally sure what blood pressure is, but she said mine was normal.After that, she weighed me and measured how tall I am on these funny looking stick rulers. I've grown like 3 inches since my last checkup! The nurse wrote all those numbers down on a form she had.Then the nurse asked me and my mom a bunch of questions to fill out the rest of the form. Some of the questions were easy, like what's my name, when is my birthday, etc. But some of them were kinda hard for me to answer.She asked if I had any allergies, which I'm not really sure about. She also asked about my medical history, but I don't remember ever being very sick before. I just tried my best to answer everything. My mom helped me out when I got stuck.One of the weirdest questions was when she asked me to rate my pain level on a scale of 0 to 10. I wasn't in any pain at all, so I just said 0. But she still made me point to the picture of the smiley face that showed no pain. I thought that was kinda silly since I had already answered verbally.Finally, after she finished the form, the nurse said the doctor would be in to see me soon. She left the room and I had to wait somemore. Waiting is the most boring part!When the doctor finally came in, she looked over the form the nurse filled out. Then she did a physical exam, checking my ears, eyes, heartbeat, and other stuff. She asked me a few more questions too.At the end, the doctor said I was very healthy and growing great! She gave me a sticker for being a good patient. I stuck it right on my shirt.Overall, even though parts of it were kinda boring, my checkup went pretty well. Filling out those forms is important so the doctors know everything about you. Next year I'll be way better at answering all the questions. I'm already practicing my medical history!篇6My Trip to the Doctor's OfficeLast week, I had to go to the doctor's office for my annual check-up. I don't really like going to the doctor much because I get nervous. But my mom says it's important to make sure I'm healthy and growing properly. This time, we had to fill out a lot of paperwork before I could see the doctor. It was kind of confusing, but my mom helped me understand what all the questions meant.When we walked into the office, the friendly receptionist at the front desk gave my mom a clipboard with a bunch of forms attached. The first one was called the "Patient RegistrationForm." It asked for basic information like my name, address, phone number, and birthday. That part was pretty easy to fill out.Next, there was a "Patient Health History" form. This one had a lot more questions that were kind of hard for me to answer by myself. It asked about any major illnesses or surgeries I've had in the past. I've been pretty healthy so far, so my mom just checked the "No" boxes for most of those.It also wanted to know if I had any allergies to medications, foods, or other things. I'm allergic to peanuts, so my mom wrote that down carefully. She told me it's really important for doctors to know about allergies so they don't give you anything that could make you sick.There were questions about whether I was currently taking any medications or using inhalers or other medical devices. I don't take any pills or use inhalers regularly. Although, my mom did mention that I use a nebulizer machine sometimes when my asthma acts up.The health history asked about my parents' medical histories too. My dad has high blood pressure, so my mom noted that. She said some conditions can run in families, so the doctors like to know about relatives' health issues.Another section asked about my diet, exercise, and sleep habits. My mom wrote that I drink milk and eat fruits and vegetables every day. She said I get plenty of physical activity by running around playing sports and games with my friends. And she noted that I usually get about 9-10 hours of sleep each night.There were a bunch of other categories like vision, hearing, developmental milestones, and mental health screening questions. My mom briefed me on what kinds of things to mention for each one. Like how I've worn glasses since kindergarten for being near-sighted, or how I sometimes have trouble focusing on schoolwork.Finally, we got to the "Reason for Visit" section where you explain why you've made the doctor's appointment. My mom wrote "Annual Well-Child Check-Up" since this was just my regular yearly exam, and not for any specific medical problem.When we finished filling out all those forms, my mom had to sign and date the forms. Then she handed the whole stack back to the receptionist. The receptionist made some copies and gave us part of it back, telling us to keep that portion for our records.After a little while, a nurse called my name and brought us back to an exam room. She took my temperature, weight, and height. She also asked me to read an eye chart on the wall.Then the doctor herself came in. She asked me and my mom some more questions and listened to my heart and breathing with her stethoscope. She felt around on my belly too to check that everything felt normal. Finally, she said I was developing perfectly for my age and gave me a sucker for being a good patient!Overall, it was kind of a long process with lots of paperwork. But I understood why the doctor needed all that information - to make sure they know my complete medical background. That way, they can keep better track of my health as I grow up. It makes me feel comfortable knowing the doctors have all the important details about me. I just hope I don't have to fill out quite so many forms next year!。
CE医疗器械警戒系统(英文版)
The Medical Device Vigilance System1. PurposeThe principal purpose of the Medical Device Vigilance System (Hereinafter referred as the ‘System ’) is to improve the protection of health and safety of patients, users and others byreducing the likelihood of reoccurrence of the incident elsewhere. This is to be achieved by the evaluation of reported incidents and, where appropriate, dissemination of information, which could be used to prevent such repetitions, or to alleviate the consequences of such incidents.2. ScopeThe ‘System’ applies to incidents with regard to:2.1 devices which carry the CE-mark (Hereinafter short for ‘CE product s ’) within EU2.2 devices that do not carry the CE-mark but where such incidents lead to responsibilities ofcorrective action(s), medical incident(s) and report(s) within EU relevant to ‘CE products’ mentioned above.2.3 devices which carry the CE mark outside EU.3．Responsibility3.1 The Manufacturer ’s Responsibilit ies: The Manufacturer shall start investigation once upon the incident notice is received, and find out the relationship among the responsible bodies, authorized EU representatives and their National Competent Authorities.3.2 The Authorized EU Representativ es’ Responsibilities: Once the incident notice is received, the authorized representatives within EU shall notify the Manufacturer immediately and assist him to deal with incidents, and meanwhile, submit to their National Competent Authorities the initial report, investigate outcome and the final report.3.3 The Sellers or Distributors ’ Responsibilities: The sellers or/and distributors shall report customers’ complaints and submit incident reports to the Manufacturer timely, and keep the sales records. 4．Procedure4.1 The management representative shall decide items to be reported to the local competent authorities after an analysis of incident report details, and joint investigation by biochemical and quality control departments.4.2 When the Manufacturer decides whether the incident shall be notified to the competent authorities or not, the following factors shall be considered: a) Incident typeCo.Ltd.Ref : QP-001-024 Version: C0 Page(s) 1st of 7Page(s) 2nd of 7b) Whether the incident is related to any medical device from the Manufacturer or not.c) The possibility of whether the incident is caused by defects on medical devices or itsinformation provided4.3 The management representative shall inform competent authorities, when one or more of the following outcomes are included:4.3.1 death of a patient, user or other person.4.3.2 serious deterioration in state of health of a patient, user or other person.A serious deterioration in state of health can include:a) life-threatening illness,b) permanent impairment of a body function or permanent damage to a body structure,c) a condition necessitating medical or surgical intervention to prevent a permanent impairment of a body function or structure.4.3.3 The incidents with the possible outcomes of death or health deterioration, or defects detection of the medical devices. Such a incident is called ‘Potential Incident’.4.4 In assessing the link between the device and the incident the Manufacturer should take account of:the opinion, based on available evidence, of healthcare professionals;the results of the Manufacturer's own preliminary assessment of the incident;evidence of previous, similar incidents;other evidence held by the Manufacturer.4.5 The incident report shall include the following contents:4.5.1 Any malfunction or deterioration in the characteristics and/or performance of a device4.5.2 One of device characteristics has the possibility of resulting in an incident without any malfunction or its performance deterioration. In this case, a ‘Potential Incident’report shall be conducted.4.5.3 Any inadequacy in the instructions for use which might lead to or might have led to the death of a patient or user or a serious deterioration in his state of health;4.6 The Incident Report TimescaleAfter receiving the incident notice and completing the preliminary assessing report by the management representative, the Manufacturer shall inform the competent authorities within timescale as follows:a）Incident: 10 daysb）Potential Incident：30 days4.7 Competent Authorities on medical devices to be reported4.7.1 If the incident occurs in EU, it shall be reported to local competent authorities.Page(s) 3rd of 74.7.2 If it occurs outside EU, it shall be reported to competent authorities where the notifiedbody is located.4.7.3 If necessary, the Manufacturer shall, under Vigilance System, inform authorized EU representatives and other relevant authority representatives of the incident.4.7.4 The Manufacturer shall as well inform the notified body which certified their products.4.8 Systematic Recall of Products4.8.1 The Manufacturer shall report to the competent authority when the recall is due to any technical or medical reasons.4.8.2 In a Recall, a ‘Advisory Notice’ shall be issued and further be submitted to the competentauthority in related country.4.8.3 The General Manager finalizes the product recall and issue of the ‘Advisory Notice’.4.9 Once the complaints from customers in local authority where the incident occurred, and reports else are received, the Manufacturer shall fulfill an initial report. Its details please see ‘The Initial Incident Report’.4.1O Investigation after the initial report4.1O.1 The Manufacturer shall conduct incident investigation based on the initial report, and inform the competent authority of the latest progress.4.1O.2 The Manufacturer shall report to the competent authority immediately if the investigationcan’t be carried out timely.4.11 Outcome of An Investigation and Follow-up4.11.1 Normally, the Manufacturer shall take the action necessary following the investigation, including consultation with the competent authority and notified body, and recall products and so on.4.11.2 There shall be a final report to the competent authority which is a written statement of the outcome of the investigation and of any action. Details please refer to ‘The Final Incident Report’.4.11.3 Examples of actions may include:a) no action;b) additional surveillance of devices in use;c) Issuance of information to users, like ‘Advisory notice’.d) Preventive action on future production;e) Field safety corrective action.f) Recall of products4.12 Link Procedure between Manufacturer and Authorized EU Representative4.12.1 Authorized EU Representative Name and Addressa）Authorized EU Representative Nameb）Postal Address, Postal Code, City, Tel, Fax, E-mail, Nation.4.12.2 The Responsibility of the Manufacturera）Ensure that each technical document of ‘CE P roducts’ provided to authorized EU Representative is in valid version.b）If the incident occurs seriously in EU, the Manufacturer shall find out reasons, and fulfill the initial report, the investigation outcome and the final report together with authorized EU representative on time, and finally send to him.c）If a serious incident occurs outside EU, the same procedures above shall apply to the Manufacturer as well, and finally inform authorized representatives.d）To guarantee the valid link of documents revising and issuance of notices to authorized EU representatives (other regions also included), the sales department of the Manufacturer shall update their latest postal address. Meanwhile, other valid methods or channels shall be noted and written in agreements signed with authorized EU representatives.4.12.3 The Responsibility of the Authorized EU Representativesa）The authorized EU representatives shall have the responsibility for registering the Manufacturer’s ‘CE Products’ to the competent authority.b）The authorized EU representatives shall keep technical documents of the Manufacturer’s ‘CE Products’ for at least 5 years after the date of manufacture of the final lot of suchproducts. What’s particular, among them technical documents of orthopedic productsshall be saved for at least 10 years after the date of manufacture of the final lot.c）The authorized EU representatives shall notify any information of the Manufacturer’s ‘CE Products’ from their competent a uthorities, their customers’ complaints, or other activities related in EU to the Manufacturer.d）The authorized EU representatives shall assist the Manufacturer to deal with the incidents related to his medical devices, and submit to their competent authorities the initial report, the investigation outcome and the final report.5、Related documents5.1 the Directive for Medical Devices (MDD), 93/42/EEC5.2 GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM,MEDDEV 2.12-1 rev75.3 Report on Incident of Advisory Notice（HS/QP-001—021）6、AnnexesAnnex 1: List of EU Competent Authorities (FEB 1998)Annex 2: The Initial Incident ReportAnnex 3: The Final Incident ReportAnnex 1:LIST OF COMPETENT AUTHORITIES (February 1998)Annex 2:The Initial Incident Report1. Competent AuthorityAddress: ____________________________________________________________2. Manufacturer InformationA) Factory: Authorized Representative within EU:B) Address:C) Contact Person:D) Tel:E) Fax:F) Date of Report3. Incident Information & Manufacturer’s Preliminary CommentsA) Product Name:B) Product Classification:C) Model & Dimensions:D) Lot No.:E) Annex:F) Certificate No.:G) Any similar incident occurred before? If so, which country did it take place? Incident Report No.:Notified Body:Address:Tel:Date of Report:H) Incident Date:I) Incident Content:J) Consequence( like occurrence of death, health deterioration):K) Preliminary Comment by Manufacturer:L) Product’s cur rent position (if available)M) Date of Follow-up ReportN) Corrective Action:O) Scheduled Time:Annex 3:The Final Incident Report1．The Competent AuthorityAddress: ____________________________________________________________ 2．Manufacturer InformationA) Factory: Authorized Representative within EU:B) Address:C) Contact Person:D) Tel:E) Fax:F) Date of Report:3．Incident Information & Manufacturer’s Final Report:A) Product Name:B) Product Classification:C) Model & Dimensions:D) Lot No.:E) Annex:F) Certificate No.:G) Any similar incident occurred before? If so, which country did it take place?Incident Report No.:Notified Body:Address:Tel:Date of Report:H) Effect from similar incident on current report:I) Incident in (Country), Incident Report No.:J) Incident Notified Body:Address:Tel:Fax:K) EU Countries already covered by this product:L) Date of the Initial Report:M) Investigation Outcome by Factory:N) Further InvestigationO) Corrective Action:P) Proposed Date of Follow-up ReportQ) Corrective Action:R) Scheduled Time:。
病人出院报告英语作文
Patient Discharge ReportUpon the completion of their treatment at our facility, it is our duty to provide a comprehensive discharge report for each patient. This report not only summarizes thepatient's medical history and treatment outcomes but also serves as a guide for their continued recovery and future healthcare needs.The discharge report begins with a brief introduction outlining the patient's basic information, including their name, age, gender, and the dates of their admission and discharge. This section also includes a summary of the patient's primary diagnosis and the reasons for their hospitalization.Following the introduction, the report delves into the details of the patient's medical history. This includes a chronological account of the patient's illnesses, surgeries, and any pre-existing conditions that may have contributedto their current health status. It also documents any medications the patient was taking prior to hospitalization and any allergies they may have.The core of the discharge report focuses on thepatient's treatment process and outcomes. This section details the course of the patient's treatment, including the specific procedures, surgeries, and medications administered. It also documents any complications or unexpected events that occurred during the patient's hospital stay. The report highlights the patient's progress and improvement, as well as any residual symptoms or ongoing health concerns.In addition to the treatment details, the discharge report also includes recommendations for the patient's continued recovery. This may include instructions for wound care, dietary restrictions, and exercise routines. The report also outlines any follow-up appointments or tests that are necessary and provides contact information for the patient to reach out with any questions or concerns.The discharge report concludes with a summary of the patient's overall condition at the time of discharge. It emphasizes the importance of adhering to the recommended recovery plan and provides guidance on how to manage any ongoing health issues. The report also serves as a valuablereference for the patient's future healthcare providers, ensuring that they have a comprehensive understanding ofthe patient's medical history and treatment outcomes.By providing a thorough and comprehensive discharge report, we ensure that our patients are well-informed about their health status and are equipped with the knowledge and resources necessary for a successful recovery. This report serves as a bridge between the hospital and the patient's home, supporting their transition back into their daily lives.**病人出院报告**在病人完成我院治疗后，我们有责任为每位病人提供一份详尽的出院报告。
药物临床试验英文缩写
药物临床试验英文缩写缩略语英文全称中文全称ADE Adverse Drug Event 药物不良事件ADR Adverse Drug Reaction 药物不良反应AE Adverse Event 不良事件AI Assistant Investigator 助理研究者BMI Body Mass Index 体质指数CI Co-investigator 合作研究者COI Coordinating Investigator 协调研究者CRC Clinical Research Coordinator 临床研究协调者CRF Case Report Form 病历报告表CRO Contract Research Organization 合同研究组织CSA Clinical Study Application 临床研究申请CTA Clinical Trial Application 临床试验申请CTX Clinical Trial Exemption 临床试验免责CTP Clinical Trial Protocol 临床试验方案CTR Clinical Trial Report 临床试验报告DSMB Data Safety and monitoring Board 数据安全及监控委员会EDC Electronic Data Capture 电子数据采集系统EDP Electronic Data Processing 电子数据处理系统FDA Food and Drug Administration 美国食品与药品管理局FR Final Report 总结报告GCP Good Clinical Practice 药物临床试验质量管理规范GCP Good Laboratory Practice 药物非临床试验质量管理规范GMP Good Manufacturing Practice 药品生产质量管理规范IB Investigator’s Brochure 研究者手册IC Informed Consent 知情同意ICF Informed Consent Form 知情同意书ICH International Conference on国际协调会议HarmonizationIDM Independent Data Monitoring 独立数据监察IDMC Independent Data Monitoring Committee 独立数据监察委员会IEC Independent Ethics Committee 独立伦理委员会IND Investigational New Drug 新药临床研究IRB Institutional Review Board 机构审查委员会IVD In Vitro Diagnostic 体外诊断IVRS Interactive Voice Response System 互动语音应答系统MA Marketing Approval/Authorization 上市许可证MCA Medicines Control Agency 英国药品监督局MHW Ministry of Health and Welfare 日本卫生福利部NDA New Drug Application 新药申请NEC New Drug Entity 新化学实体缩略语英文全称中文全称NIH National Institutes of Health 国家卫生研究所（美国）PI Principal Investigator 主要研究者PL Product License 产品许可证PMA Pre-market Approval (Application) 上市前许可（申请）PSI Statisticians in the Pharmaceutical制药业统计学家协会IndustryQA Quality Assurance 质量保证QC Quality Control 质量控制RA Regulatory Authorities 监督管理部门SA Site Assessment 现场评估SAE Serious Adverse Event 严重不良事件SAP Statistical Analysis Plan 统计分析计划SAR Serious Adverse Reaction 严重不良反应SD Source Data/Document 原始数据/文件SD Subject Diary 受试者日记SFDA State Food and Drug Administration 国家食品药品监督管理局SDV Source Data Verification 原始数据核准SEL Subject Enrollment Log 受试者入选表SI Sub-investigator 助理研究者SI Sponsor-Investigator 申办研究者SIC Subject Identification Code 受试者识别代码SOP Standard Operating Procedure 标准操作规程SPL Study Personnel List 研究人员名单SSL Subject Screening Log 受试者筛选表T&R Test and Reference Product 受试和参比试剂UAE Unexpected Adverse Event 预料外不良事件WHO World Health Organization 世界卫生组织WHO-ICDRA WHO International Conference ofWHO国际药品管理当局会议Drug Regulatory Authorities药物临床试验英文缩写英文全称中文全称Accuracy准确度Active control, AC阳性对照活性对照Adverse drug reaction, ADR药物不良反应Adverse event, AE不良事件Adverse medical events不良医学事件Adverse reaction药物不良反应Alb白蛋白ALD（Approximate Lethal Dose）近似致死剂量ALP碱性磷酸酶Alpha spending function消耗函数ALT丙氨酸氨基转换酶Analysis sets统计分析的数据集Approval批准Assistant investigator助理研究者AST天门冬酸氨基转换酶ATR衰减全反射法AUCss稳态血药浓度－时间曲线下面积Audit稽查Audit or inspection稽查／视察Audit report稽查报告Auditor稽查员Bias偏性偏倚Bioequivalence生物等效应Blank control空白对照Blind codes编制盲底Blind review盲态审核Blind review盲态检查Blinding method盲法Blinding/masking盲法/设盲Block层Block size每段的长度Carryover effect延滞效应Case history病历Case report form/ case record form CRF病例报告表病例记录表Categorical variable分类变量Cav平均浓度CD圆二色谱CL清除率Clinical equivalence临床等效应Clinical study临床研究Clinical study report临床试验的总结报告Clinical trial临床试验Clinical trial application CTA临床试验申请Clinical trial exemption CTX临床试验免责Clinical trial protocol CTP临床试验方案Clinical trial/ study report临床试验报告Cmax峰浓度Co-investigator 合作研究者Comparison对照Compliance依从性Composite variable复合变量Computer-assisted trial design CATD计算机辅助试验设计Confidence interval可信区间Confidence level置信水平Consistency test一致性检验Contract research organization CRO合同研究组织Contract/ agreement协议／合同Control group对照组Coordinating committee协调委员会Crea肌酐CRF(case report form)病例报告表Crossover design交叉设计Cross-over Study交叉研究Css稳浓度Cure痊愈Data management数据管理Database建立数据库Descriptive statistical analysis描述性统计分析DF波动系统Dichotomies二分类Diviation偏差Documentation记录／文件Dose-reaction relation剂量－反应关系Double dummy双模拟Double dummy technique双盲双模拟技术Drop out脱落DSC 差示扫描热量计Effectiveness疗效Electronic data capture EDC电子数据采集系统Electronic data processing EDP电子数据处理系统Emergency envelope应急信件End point终点Endpoint Criteria终点指标Endpoint criteria/ measurement终点指标Equivalence等效性Essential Documentation必需文件Ethics committee伦理委员会Excellent显效Exclusion criteria排除标准Factorial design析因设计Failure无效失败Final point终点Fixed-dose procedure固定剂量法Forced titration强制滴定Full analysis set全分析集GC－FTIR气相色谱－傅利叶红外联用GC－MS气相色谱－质谱联用Generic drug通用名药Global assessment variable全局评价变量GLU血糖Good clinical practice, GCP药物临床试验质量管理规范Good manufacture practice, GMP药品生产质量管理规范药物非临床研究质量管理规范Good non-clinical laboratory practice,GLPGroup sequential design成组序贯设计Health economic evaluation, HEV健康经济学评价Hypothesis test假设检验Hypothesis testing假设检验Improvement好转Inclusion Criteria入选表准Inclusion criteria 入选标准Independent ethics committee IEC独立伦理委员会Information consent form ICF知情同意书Information Gathering信息收集Informed consent IC知情同意Initial meeting启动会议Inspection检察/视察Institution inspection机构检查Institution review board, IBR机构审查委员会Intention-to –treat ITT意向性分析(－统计学）Interactive voice response system IVRS互动式语音应答系统Interim analysis期中分析International Conference of Harmonization ICH 人用药品注册技术要求国际技术协调会国际协调会议Investigational Product试验药物Investigator研究者Investigator’s brochure, IB研究者手册Last observation carry forward, LOCF最接近一次观察的结转LC－MS液相色谱－质谱联用LD50板数致死剂量LOCF, Last observation carry forward最近一次观察的结转Logic check逻辑检查LOQ (Limit of Quantization)定量限Lost of follow up失访Marketing approval/ authorization上市许可证Matched pair匹配配对Missing value缺失值Mixed effect model混合效应模式Monitor监察员Monitoring监查Monitoring Plan监察计划Monitoring Report监察报告MRT平均滞留时间MS质谱MS－MS质谱－质谱联用MTD（Maximum Tolerated Dose）最大耐受剂量Multi-center Trial多中心试验New chemical entity NCE新化学实体New drug application NDA新药申请NMR核磁共振谱Non-clinical Study非临床研究Non-inferiority非劣效性Non-parametric statistics非参数统计方法Obedience依从性ODR旋光光谱Open-label非盲Optional titration随意滴定Original medical record原始医疗记录Outcome结果Outcome Assessment结果评价Outcome assessment结果指标评价Outcome measurement结果指标Outlier离群值Parallel group design平行组设计Parameter estimation参数估计Parametric statistics参数统计方法Patient file病人档案Patient history病历Per protocol PP符合方案集Placebo安慰剂Placebo control安慰剂对照Polytomies多分类Power检验效能Precision精密度Preclinical study临床前研究Primary endpoint主要终点Primary variable主要变量Principle investigator PI主要研究者Product license PL产品许可证Protocol试验方案Protocol Amendments修正案Quality assurance QA质量保证Quality assurance unit QAU质量保证部门Quality control QC质量控制Query list query form应用疑问表Randomization随机Range check范围检查Rating scale量表Reference Product参比制剂Regulatory authorities RA监督管理部门Replication可重复RSD日内和日间相对标准差Run in准备期Safety evaluation安全性评价Safety set安全性评价的数据集Sample size样本量样本大小Scale of ordered categorical ratings有序分类指标Secondary variable次要变量Sequence 试验次序Serious adverse event SAE严重不良事件Serious adverse reaction SAR严重不良反应Seriousness严重性Severity严重程度Severity严重程度Significant level检验水准Simple Randomization简单随机Single blinding单盲Site audit 试验机构稽查SOP试验室的标准操作规程Source data SD原始数据Source data verification SDV原始数据核准Source document SD原始文件Specificity特异性Sponsor申办者Sponsor-investigator申办研究者Standard curve标准曲线Standard operating procedure SOP标准操作规程Statistic统计量Statistical analysis plan统计分析计划Statistical model统计模型Statistical tables统计分析表Stratified分层Study Audit研究稽查Study audit研究稽查Study Site研究中心Subgroup亚组Sub-investigator助理研究者Subject受试者Subject受试者Subject diary受试者日记Subject Enrollment受试者入选Subject enrollment log受试者入选表Subject identification code SIC受试者识别代码Subject Identification Code List受试者识别代码表Subject Recruitment受试者招募Subject screening log受试者筛选表Superiority 检验Survival analysis生存分析SXRD单晶X－射线衍射System audit系统稽查System Audit 系统稽查T1/2消除半衰期Target variable目标变量T－BIL总胆红素T－CHO总胆固醇Test Product受试制剂TG热重分析TLC、HPLC制备色谱Tmax峰时间TP总蛋白Transformation变量变换Treatment group试验组Trial error试验误差Trial Initial Meeting 试验启动会议Trial Master File试验总档案Trial objective试验目的Trial site试验场所Triple blinding三盲Two one-side test双单侧检验Un-blinding 揭盲Unexpected adverse event UAE预料外不良事件UV－VIS紫外－可见吸收光谱Variability变异Variable变量Visual analogy scale直观类比打分法Visual check人工检查Vulnerable subject弱势受试者Wash-out洗脱Washout period洗脱期实验室检查英文缩写英文全称中文全称血常规WBC white blood cell count白细胞计数GR% granulocyte中性粒细胞百分比LY% lymphocyte 淋巴细胞百分比MID% 中值细胞百分比EOS% eosimophil 嗜酸性粒细胞百分比AL% allergy lymphocyte 变异淋巴细胞百分比ST% 中性杆状粒细胞百分比RBC red blood cell 红细胞计数HGB hemoglobin 血红蛋白HCT hematocrit 红细胞比积红细胞比积MCV mean corpusular volume平均红细胞体积MCH mean corpusular hemoglobin平均红细胞血红蛋白含量MCHC mean corpusular hemoglobin平均红细胞血红蛋白浓度concerntration红细胞分布宽度变异RDW red blood cell volume distributionwidthPLT/BPC platelet count/blood platelet血小板计数countMPV mean platelet volume 平均血小板体积PCT plateletocrit 血小板比积PDW platelet distribution width 血小板分布宽度尿便常规PH acidity 酸碱度NIT nitrite 亚硝酸盐GLU glucose尿糖SG specific gravity 比重PRO protein 尿蛋白BLD blood 隐血BIL bilirubin 尿胆红素URO urobilinogen 尿胆原WBC white blood cell 白细胞addish计数 addish count 艾迪氏计数/HP high power objective 每高倍视野/LP low power objective 每低倍视野OB occult blood test 大便隐血试验体液常规CSF cerebrospinal 脑积夜Pandy pandy 庞氏试验生化检验TB total bilirubin 总胆红素DB direct bilirubin 直接胆红素TP total protein 总蛋白ALB albumin 白蛋白GLOB globulin 球蛋白UREA urea 尿素CREA creatinine 肌肝UA uric acid 尿酸GLU glucose 血糖ALT alanine amiotransferase 丙氨酸氨基转移酶AST aspartate aminotransferase 门冬氨酸氨基转移酶GGT γ-glutamyl transpeptadase谷氨酰转肽酶CK creatine kinase 肌酸肌酶CK-MB creatine kinase-MB 肌酸肌酶同工酶LDH lactate dehydrogenase 乳酸脱氢酶α-HBD α-hydroxybutyric dehydrogenaseα－羟丁酸脱氢酶AMY serum amylase血淀粉酶TG triglyceride 肝油三脂CHOL cholesterol 胆固醇高密度脂蛋白HDL-c high-density lipoproteincholesterolLDL-c low-density lipoprotein低密度脂蛋白cholesterolVLDL very low-density lipoprotein 极低密度脂蛋白Ca serum calcium 钙Mg serum magnesium 镁IP inorganic phosphate 无机磷ALP alkaline phosphatase 碱性磷酸酶TBA total biliary acid 总胆汁酸ASO antistreptolysin 抗链球菌溶血素O a-AG a－acid glycoprotein a－酸性糖蛋白CRP C-reactive protein C反应蛋白RF rheumatoid factor 类风湿因子MTP mili-total protein 微量蛋白IgG immunoglobin G 免疫球蛋白G IgA immunoglobin A 免疫球蛋白 A IgM immunoglobin M 免疫球蛋白M C3 complement C3 补体C3C4 complement C4 补体C4cTNT troponin T 肌钙蛋白T MYOG myoglobin肌红蛋白电解质Na sodium 钠K kalium 钾Cl chloride 氯Ga calcium钙Mg magnesium镁乙肝标志物HBV hepatitis B virus 乙肝病毒HBsAg hepatitis B surface antigen 乙肝表面抗原乙肝表面抗体HBsAb antibody to hepatitis surfaceantigenHBcAg hepatitis B core antigen 乙肝核心抗原乙肝核心抗体HBcAb antibody to hepatitis B coreantigenHBeAg hepatitis B e-antigen 乙肝e抗原HBeAb antibody to hepatitis B e-antigen乙肝e抗体ELISA enzymelinked immunosorbentassy酶联免疫吸附试验HAV hepatitis A virus 甲肝病毒HCV hepatitis C virus 丙肝病毒输血免疫全套HBV hepatitis B virus 乙型肝炎病毒HCV hepatitis C virus 丙型肝炎病毒TP treponema pallidum 梅毒螺旋体HIV human immunodeficiency virus 人类免疫缺陷病毒如有侵权请联系告知删除，感谢你们的配合！。
临床试验常用中英文词汇
临床试验常用中英文词汇SFDA Glossary：GCP, GLP, TRIAL Accuracy准确度Active control, AC阳性对照，活性对照Adverse drug reaction, ADR 药物不良反应Adverse event，AE 不良事件Adverse medical events 不良医学事件Adverse reaction药物不良反应Alb白蛋白ALD(Approximate Lethal Dose) 近似致死剂量ALP碱性磷酸酶Alpha spending function 消耗函数ALT丙氨酸氨基转换酶Analysis sets统计分析的数据集Approval 批准Assistant investigator 助理研究者AST天门冬酸氨基转换酶ATR衰减全反射法AUCss稳态血药浓度一时间曲线下面积Audit稽查Audit or inspection 稽查/视察Audit report稽查报告Auditor稽查员1 / 13临床试验常用中英文词汇Bias偏性，偏倚Bioequivalence生物等效应Blank control空白对照Blind codes编制盲底Blind review盲态审核Blind review盲态检查Blinding method 盲法Blinding/ masking 盲法，设盲Block分段Block 层Block size每段的长度BUN尿素氮Carryover effect 延滞效应Case history 病历Case report form病例报告表Case report form/ case record form，CRF 病例报告表，病例记录表Categorical variable 分类变量Cav平均浓度CD圆二色谱CL清除率Clinical equivalence 临床等效应2 / 13临床试验常用中英文词汇Clinical study 临床研究Clinical study report临床试验的总结报告Clinical trial 临床试验Clinical trial application, CTA 临床试验申请Clinical trial exemption, CTX 临床试验免责Clinical trial protocol，CTP 临床试验方案Clinical trial/ study report 临床试验报告Cmax峰浓度Co-investigator合作研究者Comparison 对照Compliance 依从性Composite variable 复合变量Computer-assisted trial design，CATD 计算机辅助试验设计Confidence interval 可信区间Confidence level 置信水平Consistency test 一致性检验Contract research organization，CRO 合同研究组织Contract/ agreement 协议/ 合同Control group 对照组Coordinating committee 协调委员会Crea肌酐CRF (case report form)病例报告表3 / 13临床试验常用中英文词汇Crossover design 交叉设计Cross-over study 交叉研究Css稳浓度Cure痊愈Data management 数据管理Database建立数据库Descriptive statistical analysis 描述性统计分析DF波动系统Dichotomies 二分类Diviation 偏差Documentation 记录 /文件Dose-reaction relation 剂量一反应关系Double blinding 双盲Double dummy 双模拟Double dummy technique 双盲双模拟技术Double-blinding 双盲Drop out 脱落DSC差示扫描热量计Effectiveness 疗效Electronic data capture, EDC 电子数据采集系统Electronic data processing, EDP 电子数据处理系统Emergency envelope 应急信件4 / 13临床试验常用中英文词汇End point 终点Endpoint criteria/ measurement 终点指标Equivalence 等效性Essential documentation 必须文件日hics committee伦理委员会Excellent 显效Exclusion criteria 排除标准Factorial design 析因设计Failure无效，失败Final point 终点Fixed-dose procedure 固定剂量法Forced titration 强制滴定Full analysis set 全分析集GC-FTIR气相色谱一傅利叶红外联用GC-MS气相色谱一质谱联用Generic drug通用名药Global assessment variable 全局评价变量GLU血糖Good clinical practice, GCP药物临床试验质量管理规范Good manufacture practice, GMP药品生产质量管理规范Good non-clinical laboratory practice, GLP 药物非临床研究质量管理规范5 / 13临床试验常用中英文词汇Group sequential design 成组序贯设计Health economic evaluation, HEV 健康经济学评价Hypothesis test 假设检验Hypothesis testing 假设检验International Conference of Harmonization，ICH 人用药品注册技术要求国际技术协调会，国际协调会议Improvement 好转Inclusion criteria 入选标准Independent ethics committee，IEC 独立伦理委员会Information consent form，ICF 知情同意书Information gathering 信息收集Informed consent，IC 知情同意Initial meeting 启动会议Inspection视察/检查Institution inspection 机构检查Institution review board, IBR 机构审查委员会Intention to treat意向治疗（--- 临床领域）Intention-to -treat, ITT 意向性分析（一统计学）Interactive voice response system, IVRS 互动式语音应答系统Interim analysis 期中分析Investigator 研究者Investigator's brochure, IB 研究者手册6 / 13临床试验常用中英文词汇IR红外吸收光谱Ka吸收速率常Last observation carry forward, LOCF 最接近一次观察的结转LC-MS液相色谱一质谱联用LD50板数致死剂量Logic check逻辑检查LOQ (Limit of Quantitation)定量限LOCF, Last observation carry forward 最近一次观察的结转Lost of follow up 失访Marketing approval/ authorization 上市许可证Matched pair匹配配对Missing value 缺失值Mixed effect model混合效应模式Monitor监查员Monitoring 监查Monitoring report 监查报告MRT平均滞留时间MS质谱MS-MS质谱一质谱联用MTD (Maximum Tolerated Dose)最大耐受剂量Multicenter trial 多中心试验Multi-center trial 多中心试验7 / 13临床试验常用中英文词汇New chemical entity, NCE 新化学实体New drug application, NDA 新药申请NMR核磁共振谱Non-clinical study 非临床研究Non-inferiority 非劣效性Non-parametric statistics 非参数统计方法Obedience依从性ODR旋光光谱Open-blinding 非盲Open-label 非盲Optional titration 随意滴定Original medical record 原始医疗记录Outcome 结果Outcome assessment结果指标评价Outcome measurement 结果指标Outlier离群值Parallel group design 平行组设计Parameter estimation 参数估计Parametric statistics 参数统计方法Patient file病人档案Patient history 病历Per protocol，PP符合方案集8 / 13临床试验常用中英文词汇Placebo安慰剂Placebo control安慰剂对照Polytomies 多分类Power检验效能Precision 精密度Preclinical study 临床前研究Primary endpoint 主要终点Primary variable 主要变量Principal investigator 主要研究者Principle investigator，PI 主要研究者Product license，PL 产品许可证Protocol试验方案Protocol试验方案Protocol amendment 方案补正Quality assurance unit，QAU 质量保证部门Quality assurance，QA 质量保证Quality control，QC 质量控制Query list，query form 应用疑问表Randomization 随机化Randomization 随机Range check范围检查Rating scale 量表9 / 13临床试验常用中英文词汇Regulatory authorities, RA 监督管理部门Replication 可重复RSD日内和日间相对标准差Run in准备期Safety evaluation 安全性评价Safety set安全性评价的数据集Sample size样本含量Sample size样本量，样本大小Scale of ordered categorical ratings 有序分类指标Secondary variable 次要变量Sequence试验次序Serious adverse event，SAE 严重不良事件Serious adverse reaction，SAR 严重不良反应Seriousness 严重性Severity严重程度Significant level 检验水准Simple randomization 简单随机Single blinding 单盲Single-blinding 单盲Site audit试验机构稽查SOP试验室的标准操作规程Source data verification，SDV 原始数据核准10 / 13临床试验常用中英文词汇Source data, SD 原始数据Source document, SD 原始文件Specificity 特异性Sponsor申办者Sponsor-investigator 申办研究者Standard curve 标准曲线Standard operating procedure，SOP 标准操作规程Statistic统计量Statistical analysis plan 统计分析计划Statistical analysis plan 统计参数计划书Statistical analysis plan，SAP 统计分析计划Statistical model 统计模型Statistical tables 统计分析表Stratified 分层Study audit研究稽查Subgroup 亚组Sub-investigator 助理研究者Subject受试者Subject diary受试者日记Subject enrollment 受试者入选Subject enrollment log 受试者入选表Subject identification code，SIC 受试者识别代码11 / 13临床试验常用中英文词汇Subject recruitment 受试者招募Subject screening log 受试者筛选表Superiority 检验Survival analysis 生存分析SXRD单晶X一射线衍射System audit系统稽查T1/2消除半衰期Target variable 目标变量T-BIL总胆红素T-CHO总胆固醇TG热重分析TLC、HPLC制备色谱Tmax峰时间TP总蛋白Transformation 变量变换Treatment group 试验组Trial error试验误差Trial master file试验总档案Trial objective 试验目的Trial site试验场所Triple blinding 三盲Two one-side test双单侧检验12 / 13临床试验常用中英文词汇Unblinding 揭盲Unblinding 破盲Unexpected adverse event, UAE 预料外不良事件UV-VIS紫外一可见吸收光谱Variability 变异Variable 变量Visual analogy scale直观类比打分法Visual check人工检查Vulnerable subject 弱势受试者Wash-out清洗期Washout period 洗脱期Well-being福利，健康13 / 13。
患者走失不良事件报告表范文
患者走失不良事件报告表范文英文回答：Patient Elopement Incident Report Form.Patient Information.Patient Name:Patient Date of Birth:Patient Medical Record Number:Incident Information.Date of Incident:Time of Incident:Location of Incident:Description of Incident: (Provide a detailed description of how the patient eloped, including any observations or witnesses.)。
Actions Taken.Immediately notify security and/or law enforcement.Conduct a search of the facility and surrounding area.Inform the patient's family or designated contact person.Document all actions taken and the outcome of the search.Root Cause Analysis.Identify any potential contributing factors to the elopement, such as:Inadequate supervision.Lack of security measures.Patient's cognitive impairment.Environmental factors.Corrective Actions.Implement measures to address the root causes identified, such as:Increasing supervision.Enhancing security measures.Providing additional training for staff.Modifying the physical environment.Additional Information.Any additional relevant information that may be helpful in understanding the incident or preventing future occurrences.Signatures.Reporting Staff Member:Signature:Date:Witness (if applicable):Signature:Date:中文回答：患者走失不良事件报告表。
med_report_form2
MEDICAL REPORT REQUEST FORM醫療報告書申請表格1. Particulars of Patient:病人資料(a) Name: (English) ( )姓名Surname 姓氏 Forename 名字(英文) Chinese 中文姓名(b) Sex: Age: Date of Birth:性別男女年齡出生日期(c) Nature of Identity Document and Number:身份證明文件類別及號碼(d) Address:地址(e) Daytime Telephone Number:日間聯絡電話號碼(f) Any Other Contact Telephone Number(s):其他聯絡電話號碼# Pleas e attach a copy of the Patient’s identity document. Please attach a copy of the Patient’s birth certificate if under 18 years of age.請附上病人的身份證明文件。
如病人年齡未滿十八歲，請附上其出生證明書副本。
2. Information Requested:索取的資料(a) Specialty:專科(b) Period: From To期間由至(c) P urpose of Report:醫療報告書之用途i) For general purpose(s):作為一般目的之用a general medical report for:一般性質的醫療報告以供furture medical purposes日後醫療用途others, please specify其他 (請註明)please tick the appropriate box請在適當空格上加上『 』號1a supplementary medical report解釋或跟進一個已發出的醫療報告# Please attach a copy of the previous medical report, if available for ease of reference如有以前的醫療報告，請附上副本以作參考Please specify items to be included in this supplementary medical report:請註明此跟進醫療報告所應包括之事項(ii) For specific purpose(s):作為指定用途insurance claim申請保險賠償employe compensation claims申索工傷賠償legal proceedings法律申訴程序certification of sickness/injury for:證明疾病./受傷以用作certification of sickness/disability in support of :證明疾病./傷殘用以支持immigration application申請移民rehousing application申請公屋徒置to Immigration Department for family reunion向人民入境事務處申請家人來港團聚others (state reason)其他 (請列明理由)Contents:內容包括nature of sickness/disability/injury疾病或傷殘或受傷性質nature of operation/treatment手術/治療的性質length of hospitalization留院日期length of sick leave granted病假日期an assessement of the degree of permanent disability following sickness/injury疾病/受傷而引起致的永久傷殘程度評估an assessment of whether the patient will be fit to work in the job at the time of sickness/injury評估病人將來是否適宜恢復其在患病/受傷前負責的工作others, please specify其他 (請註明)please tick the appropriate box『 』號23. Person to whom the Medical Report is to be sent:醫療報告書的接收人The Patient and/or the Patient’s parent/guardian by signing this Form cons ents to QEH disclosing and sending the medical report to the following person:病人及/或其父/母/監護人簽署此表格代表病人及/或其父/母/監護人同意伊利沙伯醫院向下述人士透露及發出其醫療報告書Name:姓名Address:地址Telephone Number:電話號碼# Please attach a copy of the identity document of the individual to whom this Medical Report is to be sent if not the patient himself/herself. This does not apply if the recipient is a limited company such as an insurance company.如果此醫療報告書非由病人本人接收，請附上接收人的身份證明文件副本。
事故报告表英语作文
事故报告表英语作文Title: Accident Report Form。
Accident Report Form。
Section 1: Incident Details。
Date of Incident: [Insert Date]Time of Incident: [Insert Time]Location: [Insert Location]Weather Conditions: [Insert Weather Conditions]Type of Incident: [Select from options: Slip and Fall, Vehicle Collision, Machinery Malfunction, etc.]Description of Incident: [Provide a detailed description of what happened]Section 2: Witnesses (if any)。
Name: [Insert Witness Name]Contact Information: [Insert Contact Information]Statement: [Provide a brief statement from the witness, if available]Section 3: Injured Party。
Name: [Insert Injured Person’s Name]Age: [Insert Age]Gender: [Insert Gender]Position/Role: [Insert Position/Role]Nature of Injury: [Describe the injury sustained]Medical Treatment Provided: [Outline any medical treatment administered]Section 4: Property Damage (if applicable)。
医学病例报告英语作文
医学病例报告英语作文Title: Medical Case Report A Rare Neurological Disorder。
Introduction:This case report discusses a rare neurological disorder called Moyamoya disease. The patient, a 32-year-old female, presented with recurring episodes of transient ischemic attacks (TIAs) and was diagnosed with this condition. This report aims to provide a comprehensive understanding of the disease, its clinical presentation, diagnostic procedures, treatment options, and prognosis.Clinical Presentation:The patient initially complained of frequent headaches, dizziness, and difficulty speaking. She also experienced weakness and numbness on the right side of her body. The symptoms worsened over time, leading to multiple episodesof TIAs. The patient's medical history revealed nosignificant risk factors for stroke, such as hypertension or diabetes.Diagnostic Procedures:The diagnostic workup included a detailed medical history, physical examination, and various imaging studies. Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) revealed bilateral stenosis of the distal internal carotid arteries and the proximal anterior cerebral arteries. These findings were consistent with Moyamoya disease.Treatment:The treatment plan for the patient involved a multidisciplinary approach. Medications, including antiplatelet agents and anticoagulants, were prescribed to prevent further TIAs and stroke. Additionally, the patient underwent surgical revascularization to improve blood flow to the affected areas of the brain. Direct and indirect bypass procedures were performed to establish collateralcirculation.Prognosis:The prognosis for patients with Moyamoya disease varies depending on several factors, including the severity of symptoms, age at diagnosis, and promptness of treatment. Early diagnosis and intervention can significantly improve outcomes and reduce the risk of stroke. Regular follow-up visits and close monitoring of the patient's condition are essential to manage any potential complications and ensure optimal long-term outcomes.Discussion:Moyamoya disease is a rare cerebrovascular disorder characterized by progressive narrowing of the internal carotid arteries and the development of collateral blood vessels. It primarily affects children and young adults, with a higher prevalence in individuals of Asian descent. The exact cause of the disease remains unknown, although genetic and environmental factors are believed to play arole.Conclusion:Moyamoya disease is a rare neurological disorder that requires early recognition and appropriate management to prevent potentially devastating complications such as stroke. This case report highlights the importance of a comprehensive diagnostic approach and multidisciplinary treatment strategies. Further research is needed to better understand the pathogenesis and develop novel therapeutic interventions for this challenging condition.。
医药研发中美双报英文表述 模板
医药研发中美双报英文表述模板In the realm of pharmaceutical research and development, the collaboration between the United States and China has burgeoned into a pivotal axis driving innovation and progress in the global healthcare landscape. This synergy transcends borders, uniting scientific minds and resources to tackle the most pressing medical challenges of our time. Through a lens unclouded by geopolitical tensions, let us delve into the intricacies of expressing the collaborative efforts between these two powerhouses in the English language.At the forefront of this dynamic partnership lies a concerted effort to synergize expertise and resources in the pursuit of novel therapeutics. The fusion of American ingenuity with Chinese diligence has birthed a prolific exchange of ideas, propelling drug discovery and development to unprecedented heights. From the bustling laboratories of Beijing to the hallowed halls of research institutions in Boston, the transpacific flow of knowledge fuels a virtuous cycle of innovation.One cannot overstate the significance of this collaborative endeavor in addressing global health challenges. As the world grapples with the enduring specter of infectious diseases, such as the recent COVID-19 pandemic, the imperative for international cooperation becomes ever more pronounced. Through joint research initiatives and information sharing, scientists from both nations stand shoulder to shoulder in the battle against emerging pathogens, exemplifying the spirit of scientific solidarity.Moreover, the synergy between the United States and China extends beyond the realm of infectious diseases to encompass a broad spectrum of therapeutic areas. From oncology to neurology, from cardiovascular diseases to rare genetic disorders, the collaborative efforts span theentire pharmacological landscape. This multifaceted approach not only diversifies the portfolio of potential treatments but also fosters a culture of inclusivity and collaboration in the scientific community.Central to the success of this partnership is therecognition of each other's strengths and expertise. While the United States boasts a rich tradition of biomedical research and technological innovation, China offers a vast pool of talent and a burgeoning market for clinical trials. By leveraging these complementary assets, both nations stand to benefit immensely, not only in terms of scientific advancement but also economic prosperity.In the arena of drug development, effective communicationis paramount, ensuring that ideas are conveyed with clarity and precision. As such, the language used to articulate collaborative efforts between the United States and Chinain pharmaceutical research must be imbued with clarity and devoid of ambiguity. Whether drafting research proposals, publishing scientific papers, or presenting findings at international conferences, the language employed serves as a conduit for the exchange of ideas and knowledge.Furthermore, the expression of collaboration between these two nations must transcend mere linguistic proficiency to encompass cultural sensitivity and diplomatic finesse. Given the geopolitical complexities that often characterizeSino-American relations, it is imperative that language be wielded with nuance and tact. By fostering an atmosphere of mutual respect and understanding, linguistic barriers can be overcome, paving the way for fruitful collaboration in the pursuit of scientific excellence.In conclusion, the partnership between the United States and China in pharmaceutical research and development represents a beacon of hope in an increasingly interconnected world. Through the exchange of ideas, resources, and expertise, these two nations have forged a symbiotic relationship that transcends borders and ideologies. As we navigate the uncharted waters of the 21st century, let us draw inspiration from this collaborative spirit, recognizing that together, we are greater than the sum of our parts.。
医疗行业报告 英文
医疗行业报告英文Title: Medical Industry Report。
The medical industry is a critical component of the global economy and plays a vital role in the health and well-being of individuals and communities worldwide. This report aims to provide an overview of the current state of the medical industry, including key trends, challenges, and opportunities.Overview of the Medical Industry。
The medical industry encompasses a wide range of sectors, including pharmaceuticals, medical devices, healthcare services, and biotechnology. It is a highly regulated and complex industry that is constantly evolving in response to technological advancements, demographic shifts, and changing consumer preferences.Key Trends in the Medical Industry。
One of the key trends shaping the medical industry is the increasing focus on personalized medicine. Advances in genomics and molecular biology have enabled healthcare providers to tailor treatments to individual patients based on their genetic makeup, leading to more effective and targeted therapies.Another important trend is the growing adoption of digital health technologies. Telemedicine, wearable devices, and health apps are revolutionizing the way healthcare is delivered, making it more accessible and convenient for patients while also improving the efficiency of healthcare providers.Additionally, there is a growing emphasis on value-based care, which focuses on improving patient outcomes while reducing costs. This shift towards a more holistic and patient-centered approach is driving innovation in healthcare delivery and payment models.Challenges Facing the Medical Industry。
临床试验中film
临床试验中film缩略语英文全称中文全称ADE Adverse Drug Event 药物不良事件ADR Adverse Drug Reaction 药物不良反应AE Adverse Event 不良事件AI Assistant Investigator 助理研究者。
BMI Body Mass Index 体质指数IF Investigator Form 研究者文件IND Investigational New Drug 新药临床研究IRB Institutional Review Board 机构审查委员会IVD In Vitro Diagnostic 体外诊断IVRS Interactive Voice Response System 互动语音应答系统MA Marketing Approval/Authorization 上市许可证MCA Medicines Control Agency 英国药品监督局MHW Ministry of Health and Welfare 日本卫生福利部NDA New Drug Application 新药申请NEC New Drug Entity 新化学实体NIH National Institutes of Health 国家卫生研究所（美国）PI Principal Investigator 主要研究者PL Product License 产品许可证PMA Pre-market Approval (Application) 上市前许可（申请）PSI Statisticians in the Pharmaceutical Industry 制药业统计学家协会QA Quality Assurance 质量保证QC Quality Control 质量控制RA Regulatory Authorities 监督管理部门SA Site Assessment 现场评估SAE Serious Adverse Event 严重不良事件SAP Statistical Analysis Plan 统计分析计划SAR Serious Adverse Reaction 严重不良反应SD Source Data/Document 原始数据/文件SD Subject Diary 受试者日记SFDA State Food and Drug Administration 国家食品药品监督管理局SDV Source Data Verification 原始数据核准SEL Subject Enrollment Log 受试者入选表SI Sub-investigator 助理研究者SI Sponsor-Investigator 申办研究者SIC Subject Identification Code 受试者识别代码SOP Standard Operating Procedure 标准操作规程SPL Study Personnel List 研究人员名单SSL Subject Screening Log 受试者筛选表T&R Test and Reference Product 受试和参比试剂UAE Unexpected Adverse Event 预料外不良事件WHO World Health Organization 世界卫生组织WHO-ICDRA WHO International Conference of Drug Regulatory Authorities WHO国际药品管理当局会议。
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SYMPTOMS & SIGNS
PAIN: Site(s): Character: Site(s):
(tick, circle or complete all appropriate boxes) Sharp / Cramping / Aching / Throbbing Severity: Pattern: Severity: Vomiting Pale Cold Confused Diarrhoea Blue Dizzy Aggressive Cough Flushed Weakness Intoxicated Mild / Moderate / Severe Constant / Variable Mild / Moderate / Severe Breathless or wheezy Clammy/Sweating Fit/Convulsion
BLEEDING
Nausea Faint Hot/feverish Anxious Rash/spots Other (specify):
Where:
INJURY
(tick appropriate box/boxes): Abrasion Amputation Concussion Cut Head/neck Arm Eye Hand Pulse: / minute Temperature: Other observations:
SECTION 1
Date: / / Flight No: From: To:
PATIENT DETAILS
Name: Sex: Home Address:
(Complete as applicable) Age: Seat No: Frequent flyer member? Y/N
M/F
DETAILS OF ILLNESS / ACCIDENT
If yes how many months?
CABIN CREW ACTION
Oxygen given? Medication given? (specify) Was own medication or from other passenger used? (specify) Defibrillator used? Other onboard medical equipment used (specify)
Pulse restored? YES / NO Successful / unsuccessful YES / NO YES / NO YES / NO
Respiration restored? YES / NO Successful / unsuccessful Successful / unsuccessful
Airline logo
SAMPLE MEDICAL INCIDENT REPORT
(To be completed for all incidents)
COMPLETED FORM TO BE RETURNED TO: NAME OF PERSON COMPLETING FORM: Staff ID:
Patient walked off aided/unaided Patient died on aircraft GP/Appointed Dr Hospital Remained in hotel / hospital
Crew:
Fit to operate
cut-off-portion
Transfer of Care to Ground Medical Services Sample Medical Incident Report
SAMPLE MEDICAL INCIDENT REPORT
(To be completed for all incidents)
PATIENT'S MEDICAL HISTORY
DETAILS Had this problem before? Taking any medication? Any allergies? Any recent illnesses or operations? Currently pregnant? YES YES YES YES YES / / / / / NO NO NO NO NO
YES / NO YES / NO YES / NO
If yes, did condition improve? If yes, were any shocks given?
YES / NO YES / NO
Time (GMT)
Any other treatment given: Crew Member name (CAPITALS): Staf-off-portion
TRANSFER OF CARE TO GROUND MEDICAL SERVICES
Name of Casualty: Brief Details of Incident:
Date and time of onset:
Oxygen given: Was casualty unconscious at any time? Defibrillator applied? MEDICATION ADMINISTERED: Drug: Dose:
Consciousness regained? YES / NO
OUTCOME (tick): Diversion Patient left aircraft by wheelchair
Treatment:
None
Patient recovered before landing Patient left aircraft by stretcher First Aid Ground medical Fit to fly as passenger
(circle or complete as indicated) YES / NO If yes, did patient's condition improve?
YES / NO
YES / NO
If yes, were any shocks administered?
YES / NO
Was Cardiopulmonary Resuscitation (CPR) performed? YES / NO Use of ground medical control YES / NO Assistance of on-board Dr or Health Professional Attempt to contact company doctor: Port Health Authority advised: Further information/comments:
Fracture Dislocation Ear Finger
Bruising Sprain Torso Leg Blood Pressure: Respiration:
Burn Foreign Body Back Foot/toe mm/Hg / minute
Body Part
OBSERVATIONS: