臨床試驗(yàn)常用的英文縮寫

1、百度文庫-讓每個(gè)人平等地提升自我專業(yè)術(shù)語縮略語-英文全稱中文全稱DCFdata clarificati on form數(shù)據(jù)澄清表，用于紙質(zhì)querySDVsource data verificati on原始數(shù)據(jù)核對(duì)ADEAdverse Drug Event藥物不良事件ADRAdverse Drug React ion藥物不良反應(yīng)AEAdverse Event不良事件AIAssista nt In vestigator助理研究者BMIBody Mass In dex體質(zhì)指數(shù)CICo-i nvestigator合作研究者COICoordin at ing In vestigator協(xié)調(diào)研究者CR

2、A Cli nical Research Associate臨床監(jiān)查員（臨床監(jiān)察員）CRCCli nical Research Coordi nator臨床研究協(xié)調(diào)者CRFCase Report Form病歷報(bào)告表CROContract Research Organi zati on合同研究組織CSA Cli nical Study Applicatio n臨床研究申請(qǐng)CTA Cli nical Trial Applicati on臨床試驗(yàn)申請(qǐng)CTXClinical Trial Exemption臨床試驗(yàn)免責(zé)CTPCli nical Trial Protocol臨床試驗(yàn)方案CTRCli nic

3、al Trial Report臨床試驗(yàn)報(bào)告DSMB Data Safety and mo nitori ng Board 數(shù)據(jù)安全及監(jiān)控委員會(huì)7EDCElectro nic Data Capture電子數(shù)據(jù)采集系統(tǒng)EDP Electronic Data Processing電子數(shù)據(jù)處理系統(tǒng)美國食品與藥品管理局FDA Food and Drug Admi nistratio nInvestigator' s Brochure 研究者手冊(cè)In formed Consent知情同意In formed Consent Form知情同意書Intern ati onal Conference on

4、 Harmoni zati on 國際協(xié)調(diào)會(huì)議In depe nde nt Data Mo nitori ng獨(dú)立數(shù)據(jù)監(jiān)察Independent Data Monitoring Committee 獨(dú)立數(shù)據(jù)監(jiān)察委員會(huì)In depe ndent Ethics Committee獨(dú)立倫理委員會(huì)In vestigati onal New Drug新藥臨床研究In stitutio nal Review Board機(jī)構(gòu)審查委員會(huì)In Vitro Diag nostic體外診斷In teractive Voice Resp onse System 互動(dòng)語音應(yīng)答系統(tǒng)Market ing Approval/

5、Authorizati on 上市許可證Medici nes Control Age ncy英國藥品監(jiān)督局Mi nistry of Health and Welfare日本衛(wèi)生福利部FR Fi nal ReportGCP Good Cli nical PracticeGLP Good Laboratory PracticeGMP Good Man ufacturi ng PracticeIBICICFICHIDMIDMCIECINDIRBIVDIVRSMAMCAMHWNDANew Drug ApplicationNECNew Drug En tityNIHNatio nal In stitut

6、es of HealthPIPrin cipal In vestigatorPLProduct Lice nse總結(jié)報(bào)告藥物臨床試驗(yàn)質(zhì)量管理規(guī)范藥物非臨床試驗(yàn)質(zhì)量管理規(guī)范藥品生產(chǎn)質(zhì)量管理規(guī)范新藥申請(qǐng)新化學(xué)實(shí)體國家衛(wèi)生研究所（美國）主要研究者產(chǎn)品許可證PMA Pre-market Approval (Applicatio n) 上市前許可(申請(qǐng))PSIStatisticia ns in the Pharmaceutical In dustry 制藥業(yè)統(tǒng)計(jì)學(xué)家協(xié)會(huì)QAQuality Assura nee質(zhì)量保證QC Quality Co ntrol質(zhì)量控制RARegulatory Authorit

7、ies監(jiān)督管理部門SASite Assessme nt現(xiàn)場評(píng)估SAESerious Adverse Event嚴(yán)重不良事件SAPStatistical An alysis Pla n統(tǒng)計(jì)分析計(jì)劃SARSerious Adverse React ion嚴(yán)重不良反應(yīng)SDSource Data/Docume nt原始數(shù)據(jù)/文件SDSubject Diary受試者日記SFDAState Food and Drug Administration國家食品藥品監(jiān)督管理局SDVSource Data Verificati on原始數(shù)據(jù)核準(zhǔn)SELSubject En rollme nt Log受試者入選表SIS

8、ub-i nvestigator助理研究者SISponsor-In vestigator申辦研究者SICSubject Identification Code受試者識(shí)別代碼SOPSta ndard Operati ng Procedure標(biāo)準(zhǔn)操作規(guī)程SPLStudy Personnel List研究人員名單SSLSubject Scree ning Log受試者帥選表T&RTest and Refere nee Product受試和參比試劑UAEUn expected Adverse Event預(yù)料外不良事件WHOWorld Health Orga ni zati on世界衛(wèi)生組織國際

9、藥品WHO-ICDRAWHO In ternatio nal Conference of Drug Regulatory Authorities WHO管理當(dāng)局會(huì)議Active Co ntrolAuditAudit ReportAuditorBla nk Co ntrolBli ndin g/mask ingCase HistoryCli nical study陽性對(duì)照、活性對(duì)照稽查稽查報(bào)告稽查員空白對(duì)照盲法/設(shè)盲病歷臨床研究Cli nical Trial臨床試驗(yàn)Clinical Trial Report臨床試驗(yàn)報(bào)告Complia nee依從性Coordin ati ng Committee協(xié)

10、調(diào)委員會(huì)Cross-over Study交叉研究Double Bli nding雙盲En dpo int Criteria/measureme nt終點(diǎn)指標(biāo)Esse ntial Docume ntatio n必需文件Exclusion Criteria排除標(biāo)準(zhǔn)In clusi on Criteria入選表準(zhǔn)Information Gathering信息收集In itial Meeti ng啟動(dòng)會(huì)議In spect ion檢察/視察In stituti on In spect ion機(jī)構(gòu)檢察In vestigati onal Product試驗(yàn)藥物In vestigator研究者M(jìn)on itor

11、監(jiān)查員（監(jiān)察員）Mon itori ng監(jiān)杳（監(jiān)察）Mon itori ng Plan監(jiān)查計(jì)劃（監(jiān)察計(jì)劃）Mon itori ng Report監(jiān)杳報(bào)告（監(jiān)察報(bào)告）Multi-ce nter Trial多中心試驗(yàn)Non-clinical Study非臨床研究Origi nal Medical Record原始醫(yī)療記錄Outcome Assessme nt結(jié)果評(píng)價(jià)Patie nt File病人檔案Patie nt History病歷Placebo安慰劑Placebo Co ntrol安慰劑對(duì)照Precli nical Study臨床刖研究Protocol試驗(yàn)方案Protocol Amen dme nts修正案Ran domizati on隨機(jī)Refere nee Product參比制劑Sample Size樣本量、樣本大小Serious ness嚴(yán)重性Severity嚴(yán)重程度Single Blinding單盲Sponsor申辦者Study Audit研究稽查Subject受試者Subject En rollme nt受試者入選Subject En rollme nt Log受試者入選表Subject Ide ntificati on Code List受試者識(shí)別代碼表Subject Recruitme nt受試者招募Stu