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| 中 文 | 縮 寫(xiě) | 英 文 |
| 訪視日期 | SV | subject visit |
| 知情同意 | IC | informed consent |
| 人口學(xué)資料 | DM | demographic data |
| 身高體重 | HW | height and weight |
| 既往病史 | MH | medical history |
| 體格檢查 | PE | physical examination |
| 酒精呼氣 | ALCO | alcohol（breath test） |
| 尿藥篩查 | UDS | urinary drug screening |
| 生命體征 | VS | vital signs |
| 心電圖 | ECG | electrocardiogram |
| 生化檢查 | CHEM | chemical examination |
| 血常規(guī) | HEMA | hematological examintion |
| 尿常規(guī) | URIN | urinary |
| 病毒學(xué)檢查 | VIRO | virological examination |
| 血妊娠 | PREG | pregnancy test |
| 入選標(biāo)準(zhǔn) | inclusion | inclusion criteria |
| 排除標(biāo)準(zhǔn) | exclusion | exclusion criteria |
| 入組確認(rèn)/隨機(jī) | ELIG | eligible |
| 藥代動(dòng)力學(xué) | PK | pharmacokinetics |
| 退出試驗(yàn) | ET | exit trial |
| 非計(jì)劃訪視 | SVUNS | unshedual |
| 合并用藥 | CM | concomitant medication |
| 不良事件 | AE | adverse event |
| 研究總結(jié) | Ds | |
| 臨床試驗(yàn) | Clinical Trial | |
| 方案 | Protocol | |
| 摘要 | Synopsis | |
| 研究目的 | Study Objective | |
| 研究終點(diǎn) | Study Endpoint | |
| 研究設(shè)計(jì) | Study Design | |
| 研究流程 | Study Procedure | |
| 研究結(jié)束 | Study Completion | |
| 研究終止 | Study Termination | |
| 基線 | Baseline | |
| 入組標(biāo)準(zhǔn) | Inclusion Criteria | |
| 排除標(biāo)準(zhǔn) | Exclusion Criteria | |
| 交互式語(yǔ)音應(yīng)答系統(tǒng) | IVRS | Interactive Voice Response System |
| 交互式網(wǎng)絡(luò)應(yīng)答系統(tǒng) | IWRS | Interactive Web Response System |
| 原始數(shù)據(jù)核查 | SDV | Source Data Verification |
| 電子數(shù)據(jù)采集 | EDC | Electronic Data Capture |
| 統(tǒng)計(jì)學(xué)方法 | Statistical Methods | |
| 單盲 | Single Blinding | |
| 雙盲 | Double Blinding | |
| 安慰劑 | Placebo | |
| 安慰劑對(duì)照 | Placebo Control | |
| 陽(yáng)性對(duì)照、活性對(duì)照 | Active Control | |
| 空白對(duì)照 | Blank Control | |
| 盲法/設(shè)盲 | Blinding/Masking | |
| 隨機(jī)對(duì)照雙盲試驗(yàn) | Randomized, Double-blind Study | |
| 結(jié)果評(píng)價(jià) | Outcome Assessment | |
| 多中心試驗(yàn) | Multi-center Trial | |
| 總生存期 | OS | Overall Survival |
| 無(wú)進(jìn)展生存期 | PFS | Progression Free Survival |
| 合同/協(xié)議 | Contract/Agreement | |
| 藥物臨床試驗(yàn)質(zhì)量管理規(guī)范 | GCP | Good Clinical Practice |
| 藥品生產(chǎn)質(zhì)量管理規(guī)范 | GMP | Good Manufacturing Practice |
| 標(biāo)準(zhǔn)操作規(guī)程 | SOP | Standard Operating Procedure |
| 試驗(yàn)方案 | Protocol | |
| 修正案 | Protocol Amendments | |
| 病歷報(bào)告表 | CRF | Case Report Form |
| 研究者手冊(cè) | IB | Investigator’s Brochure |
| 知情同意書(shū) | ICF | Informed Consent Form |
| 質(zhì)量保證 | QA | Quality Assurance |
| 質(zhì)量控制 | QC | Quality Control |
| 監(jiān)查 | Monitoring | |
| 監(jiān)查員 | Monitor | |
| 稽查 | Audit | |
| 稽查員 | Auditor | |
| 視察 | Inspection | |
| 國(guó)家食品藥品監(jiān)督管理局 | CFDA | China Food and Drug Administration |
| 美國(guó)食品與藥品管理局 | FDA | Food and Drug Administration |
| 國(guó)際協(xié)調(diào)會(huì)議 | ICH | International Conference on Harmonization |
| 獨(dú)立倫理委員會(huì) | IEC | Independent Ethics Committee |
| 機(jī)構(gòu)審查委員會(huì) | IRB | Institutional Review Board |
| 申辦者 | Sponsor | |
| 合同研究組織 | CRO | Contract Research Organization |
| 現(xiàn)場(chǎng)管理組織 | SMO | Site Management Organization |
| 研究中心 | Investigational Site | |
| 研究者 | Investigator | |
| 主要研究者 | PI | Principal Investigator |
| 助理研究者 | SI | Sub-investigator |
| 臨床研究協(xié)調(diào)員 | CRC | Clinical Research Coordinator |
| 啟動(dòng)會(huì) | Initial Meeting | |
| 中心啟動(dòng)訪視 | SIV-Site Initiation Visit | |
| 受試者相關(guān) | ||
| Subject 受試者 | ||
| 受試者篩選表 | Subject Screening Log | |
| 受試者入選表 | Subject Enrollment Log | |
| 受試者識(shí)別代碼 | Subject Identification Code | |
| 首例受試者入組 | FPI/FSI | First Patient/Subject In |
| 末例受試者入組 | LPI/LSI | Last Patient/Subject In |
| 末例受試者出組 | LPO/LSO | Last Patient/Subject Out |
| 招募 | Recruitment | |
| 篩選 | Screening | |
| 隨機(jī) | Randomization | |
| 入組 | Enrollment | |
| 訪視 | Visit | |
| 訪視窗口期 | Visit Window | |
| 超窗 | Out of Visit Window | |
| 隨訪 | Follow Up | |
| 脫落 | Withdrawal | |
| 依從性 | Compliance | |
| 洗脫期 | Wash-out Period | |
| 周期 | Cycle | |
| 治療分配 | Treatment Allocation | |
| 病人檔案 | Patient File | |
| 病歷 | Case Record/Medical History | |
| 原始數(shù)據(jù)/文件 | SD | Source Data/Document/Documentation |
| 受試者日記 | Subject Diary | |
| 人口統(tǒng)計(jì)學(xué) | Demography | |
| 出生日期 | DOB-Date of Birth | |
| 種族 | Race | |
| 體格檢查 | Physical Exam | |
| 生命體征 | Vital Signs | |
| 身高 | Height | |
| 體重 | Weigh | |
| 體溫 | Temperature | |
| 脈搏/心率 | Pulse/Heart rate | |
| 收縮壓 | Systolic Blood Pressure | |
| 舒張壓 | Diastolic Blood Pressure | |
| 心電圖 | ECG | Electrocardiogram |
| 胸部X光 | Chest X-ray | |
| 影像學(xué) | Image | |
| 實(shí)驗(yàn)室相關(guān) | ||
| 實(shí)驗(yàn)室評(píng)估 | Laboratory Assessment | |
| 有臨床意義/無(wú)臨床意義 | CS/NCS | Clinical Significant/Non-Clinical Significant |
| 血液學(xué)/血常規(guī) | Hematology/Blood Routine Test | |
| 血紅蛋白 | Hemoglobin | |
| 血小板 | Platelets | |
| 紅細(xì)胞 | RBC | Red Blood Cell |
| 紅細(xì)胞 | WBC | White Blood Cell |
| 中心粒細(xì)胞 | Neutrophils | |
| 淋巴細(xì)胞 | Lymphocytes | |
| 單核細(xì)胞 | Monocytes | |
| 嗜酸性粒細(xì)胞 | Eosinophils | |
| 嗜堿性粒細(xì)胞 | Basophils | |
| 尿液分析 | Urinalysis | |
| 葡萄糖 | Glucose | |
| 酮體 | Ketones | |
| 白細(xì)胞 | Leukocytes | |
| 亞硝酸鹽 | Nitrite | |
| 膽紅素 | Bilirubin | |
| 蛋白 | Protein | |
| 晶體 | Crystals | |
| pH酸堿度 | pH | pH |
| 血液生化 | Blood Biochemistry | |
| 鈣 | Calcium | |
| 鎂 | Magnesium | |
| 磷 | Phosphorus | |
| 鈉 | Sodium | |
| 鉀 | Potassium | |
| 氯 | Chloride | |
| 肌酐 | Creatinine | |
| 尿素氮 | BUN | Blood Urea Nitrogen |
| 總蛋白 | TP | Total Protein |
| 白蛋白 | Albumin | |
| 谷草轉(zhuǎn)氨酶/門(mén)冬氨酸氨基轉(zhuǎn)移酶 | AST /SGOT | AST /SGOT |
| 谷丙轉(zhuǎn)氨酶/丙氨酸氨基轉(zhuǎn)移酶 | ALT/ SGPT | ALT/ SGPT |
| 堿性磷酸酶 | ALP | Alkaline Phosphatase |
| 總膽紅素 | TB | Total Bilirubin |
| 乳酸脫氫酶 | LDH | LDH |
| 谷氨酰轉(zhuǎn)氨酶 | GGT | GGT |
| 葡萄糖 | Glucose | |
| 凝血 | Blood Coagulation | |
| 凝血酶原時(shí)間 | PT | Prothrombin Time |
| 凝血酶原時(shí)間-國(guó)際標(biāo)準(zhǔn)化比值 | PTINR | PT-INR |
| 活化部分凝血活酶時(shí)間 | APTT | APTT |
| 藥物相關(guān) | ||
| 研究產(chǎn)品 | IP | Investigational Product |
| 合并用藥 | CM | Concomitant Medication |
| 藥物接收 | Drug Receive | |
| 藥物儲(chǔ)存 | Drug Storage | |
| 藥物分發(fā) | Drug Dispense | |
| 藥物返還 | Drug Return | |
| 藥物銷(xiāo)毀 | Drug Destroy | |
| 數(shù)量 | Quantity | |
| 研究藥品編號(hào) | Medication No. | |
| 包裝 | Packaging | |
| 標(biāo)簽 | Labeling | |
| 藥物清點(diǎn) | Drug Accountability | |
| 藥物使用 | Drug Administration | |
| 藥物過(guò)量 | Overdose | |
| 劑量降低 | Dose Reduce | |
| 劑量中斷（暫停） | Dose Interrupt | |
| 劑量終止（完全終止） | Dose Discontinuation | |
| 不良事件相關(guān) | ||
| 藥物不良反應(yīng) | ADR | Adverse Drug Reaction |
| 不良事件 | AE | Adverse Event |
| 嚴(yán)重不良事件 | SAE | Serious Adverse Event |
| 嚴(yán)重性（性質(zhì)） | Seriousness | |
| 嚴(yán)重程度（程度） | Severity | |
| 級(jí)別 | Grade | |
| 導(dǎo)致死亡 | Results in death | |
| 危急生命 | Life threatening | |
| 導(dǎo)致或延長(zhǎng)住院時(shí)間 | Requires or prolongs hospitalization | |
| 先天畸形/出生缺陷 | Congenital anomaly/Birth defect | |
| 永久或重大傷殘/喪失工作能力 | Persistent or significant disability/ incapacity | |
| 輕度 | Mild | |
| 中度 | Moderate | |
| 重度 | Severe | |
| 安全評(píng)估 | Safety Assessment/Evaluation | |
| 嚴(yán)重的非預(yù)期的藥品不良反應(yīng) | SUSAR | Serious and Unexpected Suspected Adverse Reaction |
| 貧血（血紅蛋白降低） | Anemia | |
| 血紅蛋白升高 | Hemoglobin increased | |
| 高血壓 | Hypertension | |
| 低血壓 | Hypotension | |
| 腹痛 | Abdominal pain | |
| 胃痛 | Stomach pain | |
| 便秘 | Constipation | |
| 腹瀉 | Diarrhea | |
| 惡心 | Nausea | |
| 嘔吐 | Vomiting | |
| 咳嗽 | Cough | |
| 疲勞 | Fatigue | |
| 發(fā)熱 | Fever | |
| 疼痛 | Pain | |
| 厭食癥（食欲不振） | Anorexia | |
| 頭痛 | Headache | |
| 嗜睡 | Hypersomnia | |
| 失眠 | Insomnia | |
| 脫發(fā) | Alopecia | |
| 體重增加 | Weight gain | |
| 體重降低 | Weight loss | |
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