臨床試驗(yàn)常用術(shù)語(yǔ)縮寫(xiě)

1、精品專業(yè)術(shù)語(yǔ)縮略語(yǔ)英文全稱中文全稱ADEAdverseDrugEvent藥物不良事件 ADRAdverseDrugReaction藥物不良反應(yīng)AEAdverseEvent不良事件 AIAssistantInvestigator助理研究者BMIBodyMassIndex體質(zhì)指數(shù) CICo-investigator合作研究者COICoordinatingInvestigator協(xié)調(diào)研究者CRAClinicalResearchAssociate 臨床監(jiān)查員（臨床監(jiān)察員）CRCClinicalResearchCoordinator臨床研究協(xié)調(diào)者 CRFCaseReportForm病歷報(bào)告表CROCon

2、tractResearchOrganization合同研究組織 ECRF 電子化病歷報(bào)告表CSAClinicalStudyApplication臨床研究申請(qǐng) CTAClinicalTrialApplication臨床試驗(yàn)申請(qǐng)CTXClinicalTrialExemption臨床試驗(yàn)免責(zé) CTPClinicalTrialProtocol臨床試驗(yàn)方案CTRClinicalTrialReport臨床試驗(yàn)報(bào)告DSMBDataSafetyandmonitoringBoard數(shù)據(jù)安全及監(jiān)控委員會(huì)EDCElectronicDataCapture 電子數(shù)據(jù)采集系統(tǒng)EDPElectronicDataProces

3、sing電子數(shù)據(jù)處理系統(tǒng)FDAFoodandDrugAdministration美國(guó)食品與藥品管理局 FRFinalReport總結(jié)報(bào)告GCPGoodClinicalPractice藥物臨床試驗(yàn)質(zhì)量管理規(guī)范GLPGoodLaboratoryPractice藥物非臨床試驗(yàn)質(zhì)量管理規(guī)GMPGoodManufacturingPractice藥品生產(chǎn)質(zhì)量管理規(guī)范IBInvestigatorsBrochure研究者手冊(cè) ICInformedConsent知情同意ICFInformedConsentForm知情同意書(shū) ECGElectrocardiogram心電圖ICHInternationalConfe

4、renceonHarmonization國(guó)際協(xié)調(diào)會(huì)IDMIndependentDataMonitoring獨(dú)立數(shù)據(jù)監(jiān)察IDMCIndependentDataMonitoringCommittee 獨(dú)立數(shù)據(jù)監(jiān)察委員會(huì)IECIndependentEthicsCommittee 獨(dú)立倫理委員會(huì)INDInvestigationalNewDrug新藥臨床研究 IRBInstitutionalReviewBoard機(jī)構(gòu)審查委員會(huì)IVDInVitroDiagnostic體外診斷 MAMarketingApproval/Authorization上市許可證IVRSInteractiveVoiceRespons

5、eSystem互動(dòng)語(yǔ)音應(yīng)答系統(tǒng)MCAMedicinesControlAgency英國(guó)藥品監(jiān)督局MHWMinistryofHealthandWelfare日本衛(wèi)生福利部 NDANewDrugApplication新藥申請(qǐng)NECNewDrugEntity新化學(xué)實(shí)體 NIHNationalInstitutesofHealth國(guó)家衛(wèi)生研究所（美國(guó)）PIPrincipalInvestigator主要研究者 PLProductLicense產(chǎn)品許可證PMAPre-marketApproval（Application）上市前許可（申請(qǐng)）PSIStatisticiansinthePharmaceuticalI

6、ndustry制藥業(yè)統(tǒng)計(jì)學(xué)家協(xié)會(huì)QAQualityAssurance質(zhì)量保證 QCQualityControl質(zhì)量控制RARegulatoryAuthorities監(jiān)督管理部門 SASiteAssessment現(xiàn)場(chǎng)評(píng)估SAESeriousAdverseEvent嚴(yán)重不良事件 SAPStatisticalAnalysisPlan統(tǒng)計(jì)分析計(jì)劃SDSubjectDiary受試者日記 Subjectidentificationcode(SIC)受試者識(shí)別代碼精品SARSeriousAdverseReaction嚴(yán)重不良反應(yīng) SDSourceData/Document原始數(shù)據(jù)/文件精品SFDAState

7、FoodandDrugAdministration國(guó)家食品藥品監(jiān)督管理局WHO-ICDRAWHOInternationalConferenceofDrugRegulatoryAuthoritiesWHO國(guó)際藥品管理當(dāng)局會(huì)議 Unexpectedadverseevent(UAE)預(yù)料外不良事件Audit稽查 AuditReport稽查報(bào)告 Auditor稽查員 BlankControl空白對(duì)照Blinding/masking盲法/設(shè)盲 CaseHistory病歷 Clinicalstudy臨床研究ClinicalTrial臨床試驗(yàn) ClinicalTrialReport臨床試驗(yàn)報(bào)告 Compli

8、ance依從性CoordinatingCommittee協(xié)調(diào)委員會(huì) Cross-overStudy交叉研究 DoubleBlinding 雙盲EndpointCriteria/measurement終點(diǎn)指標(biāo) EssentialDocumentation必需文件ExclusionCriteria排除標(biāo)準(zhǔn) InclusionCriteria入選表準(zhǔn) InformationGathering信息收集 InitialMeeting啟動(dòng)會(huì)議 Inspection檢察/視察 InstitutionInspection機(jī)構(gòu)檢察InvestigationalProduct試驗(yàn)藥物 Investigator研究

9、者 Monitor監(jiān)查員(監(jiān)察員)Monitoring監(jiān)查(監(jiān)察)MonitoringPlan監(jiān)查計(jì)劃(監(jiān)察計(jì)劃)MonitoringReport監(jiān)查報(bào)告(監(jiān)察報(bào)告)Multi-centerTrial多中心試驗(yàn) Non-clinicalStudy非臨床研究OriginalMedicalRecord原始醫(yī)療記錄SubjectEnrollmentLog受試者入選表 SubjectIdentificationCodeList受試者識(shí)別代碼表SubjectRecruitment受試者招募 SubjectScreeningLog受試者篩選表SystemAudit系統(tǒng)稽查 StudySite研究中心 Te

10、stProduct受試制劑TrialInitialMeeting試驗(yàn)啟動(dòng)會(huì)議 TrialMasterFile試驗(yàn)總檔案 Wash-out洗脫 TrialObjective試驗(yàn)?zāi)康腡ripleBlinding三盲 Wash-outPeriod洗脫期Alb白蛋白 ALD(ApproximateLethalDose)近似致死劑量 ALP堿性磷酸酶Alphaspendingfunction消耗函數(shù) ALT丙氨酸氨基轉(zhuǎn)換酶 Approval批準(zhǔn)Analysissets統(tǒng)計(jì)分析的數(shù)據(jù)集 Approval批準(zhǔn) ATR衰減全反射法Assistantinvestigator助理研究者 AST天門冬酸氨基轉(zhuǎn)換酶A

11、UCss穩(wěn)態(tài)血藥濃度一時(shí)間曲線下面積 Standardoperatingprocedure(SOP)標(biāo)準(zhǔn)操作規(guī)程Casereportform/caserecordform(CRF)病例報(bào)告表病例記錄表Clinicaltrialapplication(CTA)臨床試驗(yàn)申請(qǐng) Clinicaltrialexemption(CTX)臨床試驗(yàn)免SDVSourceDataVerification原始數(shù)據(jù)核準(zhǔn)SISub-investigator助理研究者SICSubjectIdentificationCode受試者識(shí)別代碼SOPStandardOperatingProcedure標(biāo)準(zhǔn)操作規(guī)程SPLStudy

12、PersonnelList研究人員名單T&RTestandReferenceProduct受試和參比試劑UAEUnexpectedAdverseEvent預(yù)料外不良事件WHOWorldHealthOrganization世界衛(wèi)生組織SELSubjectEnrollmentLog受試者入選表SISponsor-Investigator申辦研究者pdpharmacodynamics藥物效應(yīng)動(dòng)力學(xué)pkpharmacokinetics藥物代謝動(dòng)力學(xué)SSLSubjectScreeningLog受試者篩選表ActiveControl陽(yáng)性對(duì)照、活性對(duì)照OutcomeAssessment結(jié)果評(píng)價(jià)Patient

13、File病人檔案PatientHistory病歷Placebo安慰劑 PlaceboControl安慰劑對(duì)照PreclinicalStudy臨床前研究Protocol試驗(yàn)方案ProtocolAmendments修正案Randomization隨機(jī)ReferenceProduct參比制劑SampleSize樣本量、樣本大小Seriousness嚴(yán)重性Severity嚴(yán)重程度SingleBlinding單盲Sponsor申辦者StudyAudit研究稽查Subject受試者SubjectEnrollment受試者入選SDSubjectDiary受試者日記 Subjectidentification

14、code(SIC)受試者識(shí)別代碼精品Clinicaltrialprotocol(CTP)臨床試驗(yàn)方案 Contractresearchorganization(CRO)合同研究組織Computer-assistedtrialdesign(CATD)計(jì)算機(jī)輔助試驗(yàn)設(shè)計(jì) Sourcedata(SD)原始數(shù)據(jù)精品Electronicdatacapture(EDC)電子數(shù)據(jù)米集系統(tǒng) Sourcedataverification(SDV)原始數(shù)據(jù)核準(zhǔn)Electronicdataprocessing(EDP)電子數(shù)據(jù)處理系統(tǒng) Subjectenrollmentlog受試者入選表Institutionreviewboard(IBR)機(jī)構(gòu)審查委員會(huì) Intention-to-treat(ITT)意向性分析(一統(tǒng)計(jì)學(xué))Interactivevoicerespo