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1、專業(yè)術(shù)語縮略語?英文全稱?????????????????????????中文全稱DCFdataclarificationform數(shù)據(jù)澄清表，用于紙質(zhì)querySDVsourcedataverification原始數(shù)據(jù)核對ADE???AdverseDrugEvent??????????????藥物不良事件ADR?AdverseDrugReaction???????????藥物不良反應(yīng)AE?????AdverseEvent????????????????????????不良事件AI?AssistantInvestiga
2、tor??????????????助理研究者?BMI?BodyMassIndex????????????????????????體質(zhì)指數(shù)CI?????Co-investigator????????????????????????合作研究者COI????CoordinatingInvestigator????????協(xié)調(diào)研究者CRA?ClinicalResearchAssociate????????臨床監(jiān)查員（臨床監(jiān)察員）CRC????ClinicalResearchCoordinator????????臨床研究協(xié)調(diào)者
3、CRF????CaseReportForm????????????????病歷報告表CRO????ContractResearchOrganization????????合同研究組織CSA?ClinicalStudyApplication????????臨床研究申請CTA?ClinicalTrialApplication????????臨床試驗申請CTX????ClinicalTrialExemption????????臨床試驗免責(zé)CTP????ClinicalTrialProtocol???????????????
4、?臨床試驗方案CTR????ClinicalTrialReport????????????????臨床試驗報告DSMB?DataSafetyandmonitoringBoard?數(shù)據(jù)安全及監(jiān)控委員會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????????美國食品與藥品管理局FR?????FinalRepo
5、rt????????????????????????總結(jié)報告GCP?GoodClinicalPractice????????????????藥物臨床試驗質(zhì)量管理規(guī)范GLP????GoodLaboratoryPractice????????藥物非臨床試驗質(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IC?????InformedConsent????????????????知情
6、同意ICF????InformedConsentForm????????????????知情同意書ICH????InternationalConferenceonHarmonization?國際協(xié)調(diào)會議IDM????IndependentDataMonitoring????????獨立數(shù)據(jù)監(jiān)察IDMC???IndependentDataMonitoringCommittee?獨立數(shù)據(jù)監(jiān)察委員會IEC????IndependentEthicsCommittee????????獨立倫理委員會IND ??Investiga
7、tionalNewDrug????????新藥臨床研究IRB????InstitutionalReviewBoard????????機構(gòu)審查委員會IVD????InVitroDiagnostic????????????????體外診斷IVRS???InteractiveVoiceResponseSystem?互動語音應(yīng)答系統(tǒng)MA?????MarketingApproval/Authorization?上市許可證MCA????MedicinesControlAgency????????英國藥品監(jiān)督局MHW????Min
8、istryofHealthandWelfare????????日本衛(wèi)生福利部NDA????NewDrugApplication????????????????新藥申請NEC????NewDrugEntity????????????????????????新化學(xué)實體NIH????NationalInstitutesofHealth????????
