術(shù)語(yǔ)縮寫(xiě) | 英文全稱(chēng)/中文全稱(chēng) |
| Adverse drug reaction /不良反應(yīng) |
AE | Adverse Event /不良事件 |
ASV | Accompanied Site Visit /陪同訪(fǎng)視 |
BD | Business Development /業(yè)務(wù)拓展 |
BS | Biostatistics / 生物統(tǒng)計(jì) |
CCF | Central Clinical File / 申辦方臨床研究文件夾 |
CD | Controlled Documents / 控制文件 |
CDA | Confidentiality Disclosure Agreement /保密協(xié)議 |
CDC | Center for Disease Control /疾病控制中心 |
CSDs | Clinical Study Documents / 臨床研究文件 |
CEC | Central Ethics Committee /中心倫理委員會(huì) |
Co-I | Coordinating Investigator / 負(fù)責(zé)協(xié)調(diào)不同中心參加多中心臨床試驗(yàn)研究者的研究者 |
COF | Change Order Form /工作范圍變更申請(qǐng)表 |
CIF | Central Investigator’s File申辦者—研究者文件夾（中心研究者文件夾） |
CM | Clinical Monitoring / Operations / 臨床監(jiān)查/運(yùn)營(yíng) |
CMA | Clinical Monitoring Associate / 臨床研究監(jiān)查助理 |
CR | Complete Response / 痊愈 |
CRA | Clinical Research Associate (equivalent to Clinical Study Monitor) 臨床監(jiān)查員 |
CRC | Clinical Research Coordinator /臨床研究協(xié)調(diào)員 |
CRF | Case Report Form or Case Record Form /病例報(bào)告表 |
CRO | Contract Research Organization /合同研究組織 |
CSDs | Clinical Study Documents /臨床研究文件 |
CSR | Clinical Study Report /臨床研究報(bào)告 |
CTA | Clinical Trial Assistant (equivalent to Clinical Research Assistant) 臨床研究助理 |
CTA | Clinical Trial Agreement /臨床試驗(yàn)協(xié)議 |
CTA | Clinical Trial Application /臨床試驗(yàn)申請(qǐng) |
CTS | Clinical Trial Supplies /臨床試驗(yàn)用品 |
CTX | Clinical Trial Exemption /臨床試驗(yàn)免責(zé) |
CV | Curriculum Vitae /履歷 |
DCF | Data Clarification Form /數(shù)據(jù)澄清表 |
DCR | Data Clarification Report (see DCF)/數(shù)據(jù)澄清報(bào)告 |
DCRF | Data Clarification and Resolution Form (see DCF)/數(shù)據(jù)澄清和解決表 |
DM | Data Management/數(shù)據(jù)管理 |
DMP | Data Management Plan/數(shù)據(jù)管理計(jì)劃書(shū) |
DQF | Data Query Form/數(shù)據(jù)疑問(wèn)表 |
DS | Data Source/數(shù)據(jù)源 |
EC | Ethics Committee /倫理委員會(huì) |
eCRF | Electronic Case Report Form/電子病歷報(bào)告表 |
EDC | Electronic Data Capture/電子數(shù)據(jù)采集 |
EOS | End of Study/研究結(jié)束 |
EU | European Union/歐盟 |
FAS | Full Analysis Set/全分析集 |
FDA | Food and Drug Administration/美國(guó)食品藥品管理局 |
FM | Approved Standard Form/批準(zhǔn)的標(biāo)準(zhǔn)表格 |
GCP | Good Clinical Practice/臨床試驗(yàn)質(zhì)量管理規(guī)范 |
GLP | Good Laboratory Practice /實(shí)驗(yàn)室質(zhì)量管理規(guī)范 |
GMP | Good Manufacturing Practice/藥品生產(chǎn)質(zhì)量管理規(guī)范 |
GRP | Good Research Practice/科學(xué)研發(fā)質(zhì)量管理規(guī)范 |
GSP | Good Statistical Practice/統(tǒng)計(jì)質(zhì)量管理規(guī)范 |
HCO | Head of Clinical Operations臨床運(yùn)營(yíng)總監(jiān) |
IB | Investigator's Brochure/研究者手冊(cè) |
IC | Informed Consent/ 知情同意 |
ICF | Informed Consent Form (also see IC)/知情同意書(shū) |
ICH | International Conference on Harmonization/國(guó)際協(xié)調(diào)會(huì)議 |
ICH-GCP | International Conference on Harmonisation Tripartite Guideline on Good Clinical Practice 國(guó)際協(xié)調(diào)會(huì)議藥品臨床試驗(yàn)質(zhì)量管理規(guī)范指南 |
IDB | Investigational Drug Brochure /試驗(yàn)藥物手冊(cè) |
IEC | Independent Ethic Committee/獨(dú)立倫理委員會(huì) |
IND | Investigational New Drug (US FDA)/研究用新藥 |
IP | Investigational Product/研究用產(chǎn)品 |
IRAEs | Immediately Reportable Adverse Events/立即上報(bào)的不良事件 |
IRB | Institutional Review Board. /機(jī)構(gòu)審查委員會(huì) |
ITT | Intention to treat/意向性治療 |
ISA | Investigator Study Agreement/研究者合同 |
ISF | Investigational Site File 研究者文件夾 |
LM | Line Manager/直線(xiàn)經(jīng)理 |
LOI | Letter of Intent/意向書(shū) |
MOH | Ministry of Health/衛(wèi)生部 |
MSA | Master Services Agreement/主服務(wù)協(xié)議 |
MTD | Maximum Tolerated Dose/最大耐受劑量 |
MW | Medical Writing/醫(yī)學(xué)寫(xiě)作 |
NA | Not Available/不可用 |
NCE | New Chemical Entity/新化學(xué)實(shí)體 |
NCS | Not Clinically Significant/無(wú)臨床意義 |
ND | Not Done/未做 |
NDA | New Drug Application./新藥上市申請(qǐng) |
OD | Other Documents/其他文件 |
OP | Operating Procedure/操作規(guī)程 |
OOS | Out Of Scope/超工作范圍 |
OS | Overall Survival/總體生存期 |
OTL | Operational Team Lead/運(yùn)營(yíng)團(tuán)隊(duì)負(fù)責(zé)人 |
PD | Protocol Deviation/方案偏離 |
PI | Principle Investigator /主要研究者 |
PIN | Personal Identification Number/個(gè)人確認(rèn)密碼 |
PK | Pharmacokinetics/藥物代謝動(dòng)力學(xué) |
PM | Project Manager/項(xiàng)目經(jīng)理 |
PMF | Project Managerment File/項(xiàng)目管理文件夾 |
PMI | Periodic Maintenance Inspection/定期維護(hù)檢查 |
PMS | Post-Marketing Surveillance/上市后藥物檢測(cè) |
PP | Project Plan/項(xiàng)目計(jì)劃 |
PP | Per Protocol/符合方案集 |
PR | Patient Recruitment/患者招募 |
QA | Quality Assurance/質(zhì)量管理 |
QC | Quality Control/質(zhì)量控制 |
RA | Regulatory Authorities/監(jiān)督管理部門(mén) |
RM | Remote Monitoring/遠(yuǎn)程監(jiān)查 |
| On-Site Monitoring/現(xiàn)場(chǎng)監(jiān)查 =On-Target Monitoring/目標(biāo)化監(jiān)查 |
SAE | Serious Adverse Event /嚴(yán)重不良事件 |
SC | Study Coordinator/研究協(xié)調(diào)員 |
SCV | Site Close-out Visit/中心關(guān)閉訪(fǎng)視 |
SSV | Site Selection Visit/中心篩選訪(fǎng)視 |
SMV | Site Monitoring Visit/中心監(jiān)查訪(fǎng)視 |
SVR | Site Visit Report/中心訪(fǎng)視報(bào)告 |
SD | Source Data/源數(shù)據(jù) |
SDV | Source Data Verification/原始數(shù)據(jù)核查 |
SFDA | State Food and Drug Administration/國(guó)家食品藥品監(jiān)督管理局 |
SIC | Subject Identification Code/受試者識(shí)別代碼 |
SIF | Site Information Form/中心信息表 |
SIV | Site Initiation Visit/中心啟動(dòng)訪(fǎng)視 |
SOP | Standard Operating Procedure/標(biāo)準(zhǔn)操作規(guī)程 |
SOW | Scope of Work/工作范圍 |
Sub-I | Subinvestigator次要研究者 |
SUSAR | Suspected Unexpected Serious Adverse Reaction 可疑的非預(yù)期的嚴(yán)重不良反應(yīng) |
TP | Template/模版 |
TMF | Trial Master File/試驗(yàn)主文檔 |
UADR | Unexpected Adverse Drug Reaction/非預(yù)期藥物不良反應(yīng) |
UADE | Unanticipated adverse drug effect/非預(yù)期的不良反應(yīng) |
UAE | Unexpected adverse event/非預(yù)期的不良事件 |
WI | Work Instruction/工作指南 |
