无需手机号,秒注册,结交更多医械法规同行,享用更多功能,让你轻松玩转社区。
您需要 登录 才可以下载或查看,没有帐号?立即注册
x
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 • 23.UK (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。 2. Subject started taking XX from March 12, 2011, XX mg/kg/d, Oral/IM/IV divided qd/bid/tid. 患者从 2011 年 3 月 12 日开始用 XX 药,XX mg/kg/d,口服/肌注/静注,QD/BID/TID。 3. There was a protocol violation because of XXX in March 12, 2011. 患者 2011 年 3 月 12 日,因 XXX 发生了方案违反 4. Subject lost of missed several doses or pills. 患者丢失或者漏服了 X 板或者 X 粒药 5. Subject refused on-site visit due to AE 受试者由于 AE 拒绝访视 6. The reason of dose change is AE, not dispensing error. 剂量改变的原因是发生 AE,不是给药错误。 7. Biochemistry assessment/test was not done on XXX. XXX 的生化检查还未做。 8. Sample was not collect for Biochemistry assessment on XXX. XXX 的生化检查标本还未采集。 9. Subject could not provide accurate date of initial diagnosis. 受试者无法提供初次诊断的准确日期。 10. CRF pages were sent to DM on last Friday. CRF 表已于上周五发给数据管理。 11. The urine is normal tested by dipstick. 尿试纸检测正常。 12. The patient is post menopausal. 病人已绝经。 13. Not mentioned in the medical record. 未在病历中提及。 14. Unsuccessful contact with the patient/family. 无法联系上患者及其家人。 15. Subject did not meet all the eligibility criteria: FSH level above 15 IU/L; liver enzymes > 3 times the normal value etc. 受试者未符合入排标准:卵泡刺激素水平大于 15 IU/L;肝酶超过正常值 3 倍等。 15. Subject’s parent or legal guardian understands the full nature and purpose of the study, including possible risks and side effects, and provides written informed consent/permission prior to any study procedures being performed. 受试者的父母或法定监护人理解该试验的全部性质和目的,包括可能的风险和副作用,并在 试验流程开展之前提供了书面的知情同意书/许可证明。 16. Clinically important concurrent disease including, but not restricted to, congestive heart failure, acute or chronic renal failure, additional severe congenital abnormality or other extenuating circumstances, including life-threatening under nutrition or rapidly progressing liver disease, that in the opinion of the investigator would interfere with study participation. 据研究者判定会影响参与试验的临床上重要的并发疾病包括,但不限于充血性心衰、严重或 慢性肾衰、额外的严重先天性畸形或其他特殊情况,包括威胁生命的营养不良或急性发作期 肝病。 2)疾病相关描述: 【肿瘤类】: 1. Because of taking Neulasta, the sum of leukocyte and neutrophil rose up significantly than range of normal value. 白细胞和中性粒细胞值高于正常值范围是因为打过升白针。 2. Regional lymph nodes cannot be assessed. 局部淋巴结无法评估。 3. ECG showed T wave changed and sinus arrhythmia, and investigator decided there was no clinical significance. 心电图显示 T 波改变及窦性心率不齐,研究者判定无临床意义; 4. Concomitant medication Zadaxin is related to AE neutropenia. 合并用药日达仙与 AE 中性粒细胞减少有关。 5. Courses have been completed (including the normal observation period) or discontinued and no further treatment courses are planned. 疗程已完成(包括常规观察期)或中止,未计划后续疗程。 6. Shortened the course (or lowered the dose level) due to adverse events. 因发生不良事件,缩短疗程(或降低剂量)。 7. Due to toxicity on a previous course, the patient is uncooperative in reporting self-administration of study medication. 由于先前疗程的毒性,患者在试验自我给药汇报方面不配合。 8. Nausea Grade 2 was present during Adjuvant chemo cycle 2 and is still present as Grade 2 during Adjuvant chemo cycle 3. 在第二个辅助化疗周期时,出现恶心反胃二级;在第三个辅助化疗周期时,依旧是二级。 9. A patient was hospitalized with abdominal pain grade 3. At discharge, the abdominal pain had improved to grade 1. Even though the patient was discharged, the SAE was still continuing because the abdominal pain had not yet resolved to grade 0. 患者因腹痛三级住院,出院时腹痛已降至一级。即使患者已出院,因腹痛还未降至 0 级,SAE 还在持续。 10. No regional lymph node metastasis histological, no additional examination for isolated tumor cells. 没有局部淋巴结的组织转移,没有转移肿瘤细胞的附加检查。 【肝病类】: 1. Subject had been vaccinated against hepatitis b in childhood. 患者在儿童期接种过乙肝疫苗。 2. Subject had not received any anti-viral treatments of chronic hepatitis b during the past year. 患者最近一年内未接受过慢性乙肝相关的抗病毒治疗。 3. Subject had taken medicine that has the effectiveness of hepatic protection and transaminase descending. 患者使用过保肝降酶药。 【糖尿病类】: 1. The SMPG (自我血糖监测) was performed on XXX. 自我血糖监测已于 XXX 执行。 二. AE&SAE 报告(首次报告、随访报告): 参考 Common Terminology Criteria for Adverse Events (CTCAE) 三. Query Wording Query 用语 1. The query/date/data has been updated. 质疑/日期/数据已更新 2. According to the protocol 根据方案规定 3. No clinical significance; clinical significance. 无临床意义;有临床意义。 4. Data has been input; Remain to system update; Data has been verified; Investigator has confirmed. 数据已录入;待系统更新;数据已核实;研究者已确认。 5. Subject refused; Subject is uncooperative; the investigator missed this part. 病人拒绝;受试者不配合;研究者漏做。 6. Loss of follow-up; Protocol Violation; Withdraw the informed consent. 随访丢失;违背方案;撤消知情同意。 7. Correction of XXXX as below: XXXXXXXXX……. . Please kindly update, thank you! 对 XXXX 的更正如下:XXXXXXXXX…….。请更新,谢谢! 8. An incorrect data was recorded on CRF Page XX. Please kindly create an on-site Query for this error, thank you. CRF XX 页数据记录有误。请为这个错误创建一个中心质疑。谢谢! 9. Subject didn`t come for on-site visit on schedule due to personal reasons. 病人因个人原因未能按计划时间随访。
|