臨床試驗常用的英文縮寫

1、_專業(yè)術(shù)語縮略語 英文全稱中文全稱ADEAdverse Drug Event藥物不良事件ADRAdverse Drug Reaction藥物不良反應(yīng)AEAdverse Event不良事件AIAssistant Investigator助理研究者BMIBody Mass Index體質(zhì)指數(shù)CICo-investigator合作研究者COICoordinating Investigator協(xié)調(diào)研究者CRAClinical Research Associate臨床監(jiān)查員（臨床監(jiān)察員）CRCClinical Research Coordinator臨床研究協(xié)調(diào)者CRFCase Report Form病

2、歷報告表CROContract Research Organization合同研究組織CSAClinical Study Application臨床研究申請CTAClinical Trial Application臨床試驗申請CTXClinical Trial Exemption臨床試驗免責(zé)CTPClinical Trial Protocol臨床試驗方案CTRClinical Trial Report臨床試驗報告DSMB Data Safety and monitoring Board數(shù)據(jù)安全及監(jiān)控委員會EDCElectronic Data Capture電子數(shù)據(jù)采集系統(tǒng)精品資料_EDPEle

3、ctronic Data Processing電子數(shù)據(jù)處理系統(tǒng)FDAFood and Drug Administration美國食品與藥品管理局FRFinal Report總結(jié)報告GCPGood Clinical Practice藥物臨床試驗質(zhì)量管理規(guī)范GLPGood Laboratory Practice藥物非臨床試驗質(zhì)量管理規(guī)范GMP Good Manufacturing Practice藥品生產(chǎn)質(zhì)量管理規(guī)范IBInvestigator s Brochure研究者手冊ICInformed Consent知情同意ICFInformed Consent Form知情同意書ICHInternat

4、ional Conference on Harmonization國際協(xié)調(diào)會議IDMIndependent Data Monitoring獨立數(shù)據(jù)監(jiān)察IDMCIndependent Data Monitoring Committee獨立數(shù)據(jù)監(jiān)察委員會IECIndependent Ethics Committee獨立倫理委員會INDInvestigational New Drug新藥臨床研究IRBInstitutional Review Board機構(gòu)審查委員會IVDIn Vitro Diagnostic體外診斷IVRSInteractive Voice Response System互動語音應(yīng)

5、答系統(tǒng)MAMarketing Approval/Authorization上市許可證MCAMedicines Control Agency英國藥品監(jiān)督局MHWMinistry of Health and Welfare日本衛(wèi)生福利部NDANew Drug Application新藥申請NECNew Drug Entity新化學(xué)實體精品資料_NIHNational Institutes of Health國家衛(wèi)生研究所（美國）PIPrincipal Investigator主要研究者PLProduct License產(chǎn)品許可證PMAPre-market Approval (Application

6、)上市前許可（申請）PSIStatisticians in the Pharmaceutical Industry制藥業(yè)統(tǒng)計學(xué)家協(xié)會QAQuality Assurance質(zhì)量保證QCQuality Control質(zhì)量控制RARegulatory Authorities監(jiān)督管理部門SASite Assessment現(xiàn)場評估SAESerious Adverse Event嚴(yán)重不良事件SAPStatistical Analysis Plan統(tǒng)計分析計劃SARSerious Adverse Reaction嚴(yán)重不良反應(yīng)SDSource Data/Document原始數(shù)據(jù) /文件SDSubject Di

7、ary受試者日記SFDAState Food and Drug Administration國家食品藥品監(jiān)督管理局SDVSource Data Verification原始數(shù)據(jù)核準(zhǔn)SELSubject Enrollment Log受試者入選表SISub-investigator助理研究者SISponsor-Investigator申辦研究者SICSubject Identification Code受試者識別代碼SOPStandard Operating Procedure標(biāo)準(zhǔn)操作規(guī)程SPLStudy Personnel List研究人員名單精品資料_SSLSubject Screening

8、Log受試者篩選表T&RTest and Reference Product受試和參比試劑UAEUnexpected Adverse Event預(yù)料外不良事件WHOWorld Health Organization世界衛(wèi)生組織WHO-ICDRA WHO International Conference of Drug Regulatory AuthoritiesWHO 國際藥品管理當(dāng)局會議Active Control陽性對照、活性對照Audit稽查Audit Report稽查報告Auditor稽查員Blank Control空白對照Blinding/masking盲法 /設(shè)盲Case

9、History病歷Clinical study臨床研究Clinical Trial臨床試驗Clinical Trial Report臨床試驗報告Compliance依從性Coordinating Committee協(xié)調(diào)委員會Cross-over Study交叉研究Double Blinding雙盲Endpoint Criteria/measurement終點指標(biāo)精品資料_Essential Documentation必需文件Exclusion Criteria排除標(biāo)準(zhǔn)Inclusion Criteria入選表準(zhǔn)Information Gathering信息收集Initial Meeting啟動

10、會議Inspection檢察 /視察Institution Inspection機構(gòu)檢察Investigational Product試驗藥物Investigator研究者M(jìn)onitor監(jiān)查員（監(jiān)察員）Monitoring監(jiān)查（監(jiān)察）Monitoring Plan監(jiān)查計劃（監(jiān)察計劃）Monitoring Report監(jiān)查報告（監(jiān)察報告）Multi-center Trial多中心試驗Non-clinical Study非臨床研究Original Medical Record原始醫(yī)療記錄Outcome Assessment結(jié)果評價Patient File病人檔案Patient History病歷P

11、lacebo安慰劑Placebo Control安慰劑對照Preclinical Study臨床前研究精品資料_Protocol試驗方案Protocol Amendments修正案Randomization隨機Reference Product參比制劑Sample Size樣本量、樣本大小Seriousness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 Enrollment受試者入選Subject Enrollment Log受試者入選表Subject Identification Code List受試者識別代碼表Subject Recruitment受試者招募Study Site研究中心Subject Screening Log受試者篩選表System Audit系統(tǒng)稽