可編輯可編輯精品精品可編輯精品臨床監(jiān)察員相關(guān)名詞縮寫(xiě)語(yǔ)英語(yǔ)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BABioavaliability生物利用度BEBioavaliability生物等效性BMIBodyMassIndex體質(zhì)指數(shù)CICo-investigator合作研究者COICoordinatingInvestigator協(xié)調(diào)研究員CRAClinicalResearchAssociate臨床監(jiān)察員CRCClinicalResearchCoordinator臨床研究協(xié)調(diào)員CRFClinicalResearchForm病例報(bào)告表CROContractResearchOrganization

合同研究組織CSA

ClinicalStudyApplication

臨床研究申請(qǐng)CTA

ClinicalTrialApplication

臨床試驗(yàn)申請(qǐng)藥物臨床試驗(yàn)網(wǎng)CTXClinicalTrialExemption

臨床試驗(yàn)免責(zé)CTPClinicalTrial

Protocol

臨床試驗(yàn)方案CTRClinicalTrialReport

臨床試驗(yàn)報(bào)告DSMB

DataSafetyandmonitoringBoard

數(shù)據(jù)安全及監(jiān)控委員會(huì)ECEthnicsCommittee倫理委員會(huì)EDC

ElectronicDataCapture

電子數(shù)據(jù)采集系統(tǒng)EDP

ElectronicDataProcessing

電子數(shù)據(jù)處理系統(tǒng)FDA

FoodandDrugAdministration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)范GMP

GoodManufacturingPractice

藥品生產(chǎn)質(zhì)量管理規(guī)范

IB

Investigator’sBrochure

研究者手冊(cè)ICInformedConsent知情同意ICFInformedConsentForm

知情同意書(shū)

ICHInternationalConferenceonHarmonizationOfTechnicalRequirementsforRegistrationofpharmaceuticalsforHumanuse國(guó)際協(xié)調(diào)會(huì)議

IDM

IndependentDataMonitoring

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)可編輯可編輯精品精品可編輯精品

IECIndependentEthicsCommittee

獨(dú)立倫理委員會(huì)INDInvestigationalNewDrug新藥臨床研究IRB

InstitutionalReviewBoard

機(jī)構(gòu)審查委員會(huì)IVDInVitroDiagnostic體外診斷IVRSInteractiveVoiceResponseSystem

互動(dòng)語(yǔ)音應(yīng)答系統(tǒng)MAMarketingApproval/Authorization上市許可證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PKpharmacokinetics藥物代謝動(dòng)力學(xué)PMAPre-marketApproval(Application)上市前許可（申請(qǐng)）PSIStatisticiansinthePharmaceuticalIndustry

制藥業(yè)統(tǒng)計(jì)學(xué)家協(xié)會(huì)

QA

QualityAssurance質(zhì)量保證QCQualityControl質(zhì)量控制RA

RegulatoryAuthorities監(jiān)督管理部門(mén)SASite

Assessment

現(xiàn)場(chǎng)評(píng)估SAE

SeriousAdverseEvent嚴(yán)重不良事件SAPStatisticalAnalysisPlan統(tǒng)計(jì)分析計(jì)劃SARSeriousAdverseReaction嚴(yán)重不良反應(yīng)SD

SourceData/Document原始數(shù)據(jù)/文件SDSubjectDiary受試者日記SFDAStateFoodandDrugAdministration國(guó)家食品藥品監(jiān)督管理局SDVSourceDataVerification

原始數(shù)據(jù)核準(zhǔn)SELSubjectEnrollmentLog

受試者入選表SISub-investigator助理研究者SI

Sponsor-Investigator申辦研究者SICSubjectIdentificationCode

受試者識(shí)別代碼SOPStandardOperatingProcedure標(biāo)準(zhǔn)操作規(guī)程SPLStudyPersonnelList

研究人員名單SSL

SubjectScreeningLog

受試者篩選表T&R

TestandReferenceProduct受試和參比試劑UAE

UnexpectedAdverseEvent

預(yù)料外不良事件WHOWorldHealthOrganization

世界衛(wèi)生組織WHO-ICDRA

WHOInternationalConferenceofDrugRegulatoryAuthorities

WHO國(guó)際藥品管理當(dāng)局會(huì)議可編輯可編輯精品精品可編輯精品可編輯可編輯精品精品可編輯精品

常見(jiàn)中英文對(duì)照表ActiveControl陽(yáng)性對(duì)照、活性對(duì)照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

Compliance依從性CoordinatingCommittee協(xié)調(diào)委員會(huì)Cross-overStudy交叉研究DoubleBlinding

雙盲DeclarationofHelisinki赫爾辛基宣言

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

OutcomeAssessment結(jié)果評(píng)價(jià)PatientFile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)方案可編輯可編輯精品精品可編輯精品

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SubjectEnrollmentLog受試者入選表

SubjectIdentificationCodeList受試者識(shí)別代碼表SubjectRecruitment

受試者招募

Study