==== 英文缩写汇总 ====

----

==== A ====

^缩写^全称^中文|
|[[:概念:不良事件|AE]]|[[:概念:不良事件|Adverse Event]]|[[:概念:不良事件|]]|
|ANCOVA|Analysis of Covariance|协方差分析|
|ANOVA|Analysis of Variance|方差分析|
|AUC|Area Under The Plasma Concentration–Time Curve|血浆浓度-时间曲线下面积|
|[[:概念:不良事件#三_其他相关概念|ADE]]|[[:概念:不良事件#三_其他相关概念|Adverse Drug Event]]|[[:概念:不良事件#三_其他相关概念|药物不良事件]]|

==== B ====

^缩写^全称^中文|
|BID|Twice Daily|每日两次|
|BE|Bioequivalence|生物等效性|
|BMI|Body Mass Index|体质指数|
|BP|Blood Pressure|血压|

==== C ====

^缩写^全称^中文|
|CDA|Confidential Disclosure Agreement|保密协议|
|[[http://www.cfda.gov.cn|CFDA]]|[[http://www.cfda.gov.cn|China Food and Drug Administration]]|[[http://www.cfda.gov.cn|中国国家食品药品监督管理总局]]|
|CFR|The Code of Federal Regulations|联邦法规|
|C<sub>max</sub> |Maximum Concentration|最大浓度|
|COA|Certificate(s) of Analysis|质检证书|
|CPM|Clinical Project Manager|临床项目经理|
|[[:概念:病例报告表|CRF]]|[[:概念:病例报告表|Case Report Form]]|[[:概念:病例报告表|病历报告表]]|
|[[:概念:合同研究组织|CRO]]|[[:概念:合同研究组织|Contract Research Organization]]|[[:概念:合同研究组织|]]|
|CSR|Clinical Study Report|临床研究报告|

==== D ====

^缩写^全称^中文|
|DILI|Drug-Induced Liver Injury|药物性肝损伤|
|DMARD|Disease Modifying Antirheumatic Drug|改善病情抗风湿药|
|DSMB|Data and Safety Monitoring Board|数据与安全监察委员会|
|DVP|Data Validation Plan|数据核查计划|

==== E ====

^缩写^全称^中文|
|ECG|Electrocardiogram|心电图|
|[[:概念:病例报告表|eCRF]]|[[:概念:病例报告表|Electronic Case Report Form]]|[[:概念:病例报告表|电子病例报告表]]|
|EDC|Electronic Data Capture|电子数据采集|
|ER|Emergency Room|急诊室|
|ESR|Erythrocyte Sedimentation Rate|红细胞沉降率|

==== F ====

^缩写^全称^中文|
|FAS|Full Analysis Set|全数据分析集|
|FDA|Food and Drug Administration|[[https://www.fda.gov|美国食品药品监督管理局]]|
|FDF|Financial Disclosure Form|财务披露表|

==== G ====

^缩写^全称^中文|
|[[:法规:ich-gcp|GCP]]|[[:法规:ich-gcp|Good Clinical Practice]]|[[:法规:药物临床试验质量管理规范|临床试验质量管理规范]]|
|GI|Gastrointestinal|胃肠道|
|GMP|Good Manufacturing Practice|药品生产质量管理规范|

==== H ====

^缩写^全称^中文|
|HBsAg|Hepatitis B surface Antigen|乙型肝炎表面抗原|
|HLGT|High Level Group Term|高级别组术语|
|HLV|High Level Term|高级别术语|
|HIV|Human Immunodeficiency Virus|人类免疫缺陷病毒|
|HT|Included terms|收录术语|


==== I ====

^缩写^全称^中文|
|[[:概念:研究者手册|IB]]|[[:概念:研究者手册|Investigator's Brochure]]|[[:概念:研究者手册|]]|
|ICD|International Classification Disease|国际疾病分类|
|[[:概念:知情同意|ICF]]|[[:概念:知情同意|Informed Consent Form]]|[[:概念:知情同意|知情同意书]]|
|[[:概念:国际协调理事会|ICH]]|[[:概念:国际协调理事会|International Conference on Harmonisation]]|[[:概念:国际协调理事会|人用药品注册技术要求国际协调会]]|
|i.d.| |皮内注射|
|IDMC|Independent Data-Monitoring Committee|独立数据监查委员会|
|[[:概念:伦理委员会|IEC]]|[[:概念:伦理委员会|Independent Ethics Committee]]|[[:概念:伦理委员会|独立伦理委员会]]|
|i.h.| |皮下注射|
|IgG|Immunoglobulin G|免疫球蛋白G|
|i.m| |肌内注射|
|IND|Investigational New Drug|新药临床研究|
|IP|Investigational product|研究药物|
|[[:概念:伦理委员会|IRB]]|[[:概念:伦理委员会|Institutional Review Board]]|[[:概念:伦理委员会|机构审查委员会]]|
|IRT|Interactive Response Technology|交互式应答技术|
|ISF|Investigator Site File|研究中心文件夹|
|IT|Included Terms|收录术语|
|i.v| |静脉注射|
|i.v.gtt| |静脉滴注|
|IVD|In Vitro Diagnostic|体外诊断|
|IVRS|Interactive Voice Response System|交互语音应答系统|

==== J ====

^缩写^全称^中文|
| | | |

__false__


==== L ====

^缩写^全称^中文|
|LLT|Low Level Term|低级别术语|

==== M ====

^缩写^全称^中文|
|MedDRA<sup>®</sup>    |Medical Dictionary for Regulatory Activities|ICH 国际医学用语词典|

==== N ====

^缩写^全称^中文|
|[[https://www.nmpa.gov.cn/|NMPA]]|National Medical Products Administration|国家药品监督管理局|

==== O ====

^缩写^全称^中文|
| | |

==== P ==== 

^缩写^全称^中文|
|PBO|Placebo|安慰剂| 
|PK |Pharmacokinetic(s)|药代动力学|
|PD|Pharmacodynamics|药效学|
|PPS|Per-Protocol Set|符合方案集|
|PRO|Patient Reported Outcome|患者报告结局|
|PSOC|Primary System Organ Class|主要系统器官类|
|PT|Preferred Term|首选术语|

==== Q ====

^缩写^全称^中文|
|q.d.|Once Daily|每日一次|

==== R ====

^缩写^全称^中文|
|RA|Rheumatoid Arthritis|类风湿性关节炎|
|RBC|Red Blood Cell|红细胞|
|RDC|Remote Data Acess|远程数据获取|

==== S ====

^缩写^全称^中文|
|SAE|Serious Adverse Event|严重不良事件|
|SAP|Statistical Analysis Plan|统计分析计划|
|SAR|Statistical Analysis Reoort|统计分析报告|
|SC|Study Coordinator|临床研究协调者|
|SD|Standard Deviation|标准差|
|SD|Source Data/Document|源数据/文件|
|SDV|Source Data Verification|原始数据核准|
|SFU|Safety Follow-Up (Visit)|安全性随访|
|SOC|System Organ Class|系统器官分类|
|SOP|Standard Operating Procedure|标准操作规程|
|SS|Safety Set|安全性数据集|
|SUSAR|Suspected Unexpected Serious Adverse Reaction|可疑非预期严重不良反应|

==== T ====

^缩写^全称^中文|
|TB|Tuberculosis|结核病|
|TEAE|Treatment-Emergent Adverse Event|治疗引发的不良事件|
|TIA|Transient Ischemic Attack|短暂性脑缺血发作|
|t.i.d|Three Times a Day|每日三次|
|TNF|Tumor Necrosis Factor|肿瘤坏死因子|

==== U ====

^缩写^全称^中文|
|UAT|User Acceptance Testing|用户接受测试|
|ULN|The Upper Limit of Normal Value|正常值上限|

==== V ====

^缩写^全称^中文|
| | |

==== W ====

^缩写^全称^中文|
|[[https://who-umc.org/whodrug/|WHO DD]]|WHO Drug Dictionary|世界卫生组织药物词典|
|WHO DDE|WHO Drug Dictionary Enhanced|世界卫生组织药物词典增强版|
|WHO HD|WHO Herbal Dictionary|世界卫生组织草药词典|
|WD|Withdrawal|退出|
| | |

==== X ====

^缩写^全称^中文|
| | |

==== Y ====

^缩写^全称^中文|
| | |

==== Z ====

^缩写^全称^中文|
| | |