编号 | 术语缩写 | 英文全称/中文全称 |
ADR | Adver drug reaction/不良反应 | |
AE | Adver Event/不良事件 | |
ASV | Accompanied Site Visit/陪同访视 | |
BD | 业务拓展Business Development | |
BS | 生物统计 Biostatistics | |
CATD | Computer aided test design/计算机辅助试验设计 | |
CCF | Central Clinical File申办方临床研究文件夹 | |
CD | Controlled Documents/控制文件 | |
CDA | Confidentiality Disclosure Agreement/保密协议 | |
CDC | Center for Dia Control/疾病控制中心 | |
CSDs | Clinical Study Documents临床研究文件 | |
CEC | Central Ethics Committee/中心伦理委员会 | |
Co-I | Coordinating Investigator负责协调不同中心参加多中心临床试验研究者的研究者 | |
COF | Change Order Form/工作范围变更申请表 | |
COA | /药物检测报告 | |
CIF | Central Investigator’s File申办者—研究者文件夹（中心研究者文件夹） | |
CM | Clinical Monitoring / Operations/临床监查/运营 | |
CMA | Clinical Monitoring Associate/临床研究监查助理 | |
CR | Complete Respon痊愈 | |
CRA | Clinical Rearch Associate (equivalent to Clinical Study Monitor) 临床监查员 | |
CRC | Clinical Rearch Coordinator/临床研究协调员 | |
CRF | Ca Report Form or Ca Record Form/病例报告表 | |
CRO | Contract Rearch Organization/合同研究组织 | |
CSDs | Clinical Study Documents/临床研究文件 | |
CSR | Clinical Study Report/临床研究报告 | |
CTA | Clinical Trial Assistant (equivalent to Clinical Rearch Assistant) 临床研究助理 | |
CTA | Clinical Trial Agreement/临床试验协议 | |
CTA | Clinical Trial Application/临床试验申请 | |
CTP | Clinical trial plan/临床试验方案 | |
CTS | Clinical Trial Supplies/临床试验用品 | |
CTX | Clinical Trial Exemption/临床试验免责 | |
CV | Curriculum Vitae/履历 | |
DCF | Data Clarification Form /数据澄清表 | |
DCR | Data Clarification Report (e DCF)/数据澄清报告 | |
DCRF | Data Clarification and Resolution Form (e DCF)/数据澄清和解决表 | |
DM | Data Management/数据管理 | |
DMP | Data Management Plan/数据管理计划书 | |
DQF | Data Query Form/数据疑问表 | |
DS | Data Source/数据源 | |
EC | Ethics Committee /伦理委员会 | |
eCRF | Electronic Ca Report Form/电子病历报告表 | |
EDC | Electronic Data Capture/电子数据采集 | |
EDP | Electronic data processing system/电子数据处理系统 | |
EOS | End of Study/研究结束 | |
EU | European Union/欧盟 | |
FAS | Full Analysis Set/全分析集 | |
FDA | Food and Drug Administration/美国食品药品管理局 | |
FM | Approved Standard Form/批准的标准表格 | |
GCP | Good Clinical Practice/临床试验质量管理规范 | |
GLP | Good Laboratory Practice /实验室质量管理规范 | |
GMP | Good Manufacturing Practice/药品生产质量管理规范 | |
GRP | Good Rearch Practice/科学研发质量管理规范 | |
GSP | Good Statistical Practice/统计质量管理规范 | |
HCO | Head of Clinical Operations临床运营总监 | |
HVE | Health economic evaluation/健康经济学评价 | |
IB | Investigator's Brochure/研究者手册 | |
IC | Informed Connt/ 知情同意 | |
ICF | Informed Connt Form (also e IC)/知情同意书 | |
ICH | International Conference on Harmonization/国际协调会议 | |
ICH-GCP | International Conference on Harmonisation Tripartite Guideline on Good Clinical Practice 国际协调会议药品临床试验质量管理规范指南 | |
IDB | Investigational Drug Brochure /试验药物手册 | |
IEC | Independent Ethic Committee/独立伦理委员会 | |
IND | Investigational New Drug (US FDA)/研究用新药 | |
IP | Investigational Product/研究用产品 | |
IRAEs | Immediately Reportable Adver Events/立即上报的不良事件 | |
IRB | Institutional Review Board. /机构审查委员会 | |
ITT | Intention to treat/意向性治疗 | |
ISA | Investigator Study Agreement/研究者合同 | |
ISF | Investigational Site File 研究者文件夹 | |
LM | Line Manager/直线经理 | |
LOI | Letter of Intent/意向书 | |
MOH | Ministry of Health/卫生部 | |
MSA | Master Services Agreement/主服务协议 | |
MTD | Maximum Tolerated Do/最大耐受剂量 | |
MW | Medical Writing/医学写作 | |
NA | Not Available/不可用 | |
NCE | New Chemical Entity/新化学实体 | |
NCS | Not Clinically Significant/无临床意义 | |
ND | Not Done/未做 | |
NDA | New Drug Application./新药上市申请 | |
OD | Other Documents/其他文件 | |
OP | Operating Procedure/操作规程 | |
OOS | Out Of Scope/超工作范围 | |
OS | Overall Survival/总体生存期 | |
OTL | Operational Team Lead/运营团队负责人 | |
PL | Product licen/产品许可证书 | |
PD | Protocol Deviation/方案偏离 | |
PI | Principle Investigator /主要研究者 | |
PIN | Personal Identification Number/个人确认密码 | |
PK | Pharmacokinetics/药物代谢动力学 | |
PM | Project Manager/项目经理 | |
PMF | Project Managerment File/项目管理文件夹 | |
PMI | Periodic Maintenance Inspection/定期维护检查 | |
PMS | Post-Marketing Surveillance/上市后药物检测 | |
PP | Project Plan/项目计划 | |
PP | Per Protocol/符合方案集 | |
PR | Patient Recruitment/患者招募 | |
QA | Quality Assurance/质量管理 | |
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