臨床試驗常用的英文縮寫

1、百度文庫-讓每個人平等地提升自我專業(yè)術語7Clinical Research Coordinator臨床研究協(xié)調者Case Report Form病歷報告表Contract Research Organization 合同研究組織縮略語英文全稱DCF data clarification formSDV source data verificationADE Adverse Drug EventADR Adverse Drug ReactionAEAdverse EventAIAssistant InvestigatorBMI Body Mass IndexCI Co-investigator

2、COI Coordinating InvestigatorCRA Clinical Research AssociateCRCCRFCROCSA Clinical Study ApplicationCTA Clinical Trial ApplicationCTXClinical Trial ExemptionCTPClinical Trial ProtocolCTRClinical Trial Report中文全稱數(shù)據(jù)澄清表，用于紙質 query原始數(shù)據(jù)核對藥物不良事件藥物不良反應不良事件助理研究者體質指數(shù)合作研究者協(xié)調研究者臨床監(jiān)查員（臨床監(jiān)察員）臨床研究申請臨床試驗申請臨床試驗免責臨床試

3、驗方案臨床試驗報告DSMB Data Safety and monitoring Board 數(shù)據(jù)安全及監(jiān)控委員會EDC Electronic 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)FDA Food and Drug Administration美國食品與藥品管理局FR Final ReportGCP Good Clinical PracticeGLP Good Laboratory PracticeGMP Good Manufacturing Practice總結報告藥物臨床試驗質量管理規(guī)范藥物非臨床試驗質量管理規(guī)

4、范藥品生產質量管理規(guī)范舊 Investigator ' s Brochure 研究者手冊IC Informed Consent知情同意ICF Informed Consent Form知情同意書ICH International Conference on Harmonization 國際協(xié)調會議IDM Independent Data Monitoring 獨立數(shù)據(jù)監(jiān)察IDMC Independent Data Monitoring Committee 獨立數(shù)據(jù)監(jiān)察委員會IEC Independent Ethics Committee獨立倫理委員會IND Investigationa

5、l New Drug新藥臨床研究IRB Institutional Review Board 機構審查委員會IVD In Vitro Diagnostic體外診斷IVRS Interactive Voice Response System 互動語音應答系統(tǒng)英國藥品監(jiān)督局日本衛(wèi)生福利部新藥申請新化學實體國家衛(wèi)生研究所（美國）MA Marketing Approval/Authorization 上市許可證MCA Medicines Control AgencyMHW Ministry of Health and WelfareNDANew Drug ApplicationNECNew Drug

6、EntityNIH National Institutes of HealthPI Principal Investigator主要研究者PL Product License產品許可證PMA Pre-market Approval (Application) 上市前許可(申請)PSI Statisticians in the Pharmaceutical Industry 制藥業(yè)統(tǒng)計學家協(xié)會QA Quality Assurance質量保證QC Quality Control質量控制State Food and Drug AdministrationRARegulatory Authoritie

7、sSASite AssessmentSAE Serious Adverse EventSAP Statistical Analysis PlanSAR Serious Adverse ReactionSDSource Data/DocumentSDSubject DiarySFDA監(jiān)督管理部門現(xiàn)場評估嚴重不良事件統(tǒng)計分析計劃嚴重不良反應原始數(shù)據(jù)/文件受試者日記國家食品藥品監(jiān)督管理局SDVSource Data VerificationSELSubject Enrollment LogSI Sub-investigatorSI Sponsor-InvestigatorSIC Subject Id

8、entification CodeSOP Standard Operating ProcedureSPL Study Personnel ListSSL Subject Screening LogT&RTest and Reference ProductUAEUnexpected Adverse EventWHO World Health OrganizationWHO-ICDRA管理當局會議原始數(shù)據(jù)核準受試者入選表助理研究者申辦研究者受試者識別代碼標準操作規(guī)程研究人員名單受試者篩選表受試和參比試劑預料外不良事件世界衛(wèi)生組織WHO International Conference of

9、 Drug Regulatory Authorities WHO國際藥品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/設盲Case 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)調委員會Cross-over Study交叉研究Double Blinding雙盲Endpoint Criteri

10、a/measurement終點指標Essential Documentation必需文件Exclusion Criteria排除標準Inclusion Criteria入選表準Information Gathering信息收集Initial Meeting啟動會議Inspection檢察/視察Institution Inspection機構檢察Investigational Product試驗藥物Investigator研究者Monitor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）Mu

11、lti-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結果評價Patient File病人檔案Patient History病歷Placebo安慰劑Placebo Control安慰劑對照Preclinical Study愴林刖研究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嚴重性Severity嚴重程度Single Blinding單旨Sponsor申辦者Study AuditSubjectSubject EnrollmentSubject Enrollment LogSubject Identification Code ListSubject RecruitmentStudy SiteSubject Screening LogSystem AuditTest