术语缩写 | 英文全称/中文全称 |
| Adverse drug reaction /不良反应 |
AE | Adverse Event /不良事件 |
ASV | Accompanied Site Visit /陪同访视 |
BD | Business Development /业务拓展 |
BS | Biostatistics / 生物统计 |
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 Disease 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 |
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 Response / 痊愈 |
CRA | Clinical Research Associate (equivalent to Clinical Study Monitor) 临床监查员 |
CRC | Clinical Research Coordinator /临床研究协调员 |
CRF | Case Report Form or Case Record Form /病例报告表 |
CRO | Contract Research 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 Research 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 |
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 (see DCF)/数据澄清报告 |
DCRF | Data Clarification and Resolution Form (see 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 Case Report Form/电子病历报告表 |
EDC | Electronic Data Capture/电子数据采集 |
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 Research 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 |
IB | Investigator's Brochure/研究者手册 |
IC | Informed Consent/ 知情同意 |
ICF | Informed Consent Form (also see 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 Adverse 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 Dose/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 |
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 |
QC | Quality Control/质量控制 |
RA | Regulatory Authorities/监督管理部门 |
RM | Remote Monitoring/远程监查 |
| On-Site Monitoring/现场监查 =On-Target Monitoring/目标化监查 |
SAE | Serious Adverse Event /严重不良事件 |
SC | Study Coordinator/研究协调员 |
SCV | Site Close-out Visit/中心关闭访视 |
SSV | Site Selection Visit/中心筛选访视 |
SMV | Site Monitoring Visit/中心监查访视 |
SVR | Site Visit Report/中心访视报告 |
SD | Source Data/源数据 |
SDV | Source Data Verification/原始数据核查 |
SFDA | State Food and Drug Administration/国家食品药品监督管理局 |
SIC | Subject Identification Code/受试者识别代码 |
SIF | Site Information Form/中心信息表 |
SIV | Site Initiation Visit/中心启动访视 |
SOP | Standard Operating Procedure/标准操作规程 |
SOW | Scope of Work/工作范围 |
Sub-I | Subinvestigator次要研究者 |
SUSAR | Suspected Unexpected Serious Adverse Reaction 可疑的非预期的严重不良反应 |
TP | Template/模版 |
TMF | Trial Master File/试验主文档 |
UADR | Unexpected Adverse Drug Reaction/非预期药物不良反应 |
UADE | Unanticipated adverse drug effect/非预期的不良反应 |
UAE | Unexpected adverse event/非预期的不良事件 |
WI | Work Instruction/工作指南 |
