药物临床试验英文缩写缩略语英文全称中文全称ADEAdverseDrugEvent药物不良事件ADRAdverseDrugReaction药物不良反应AEAdverseEvent不良事件AIAssistantInvestigator助理研究者BMIBodyMassIndex体质指数CICo-investigator合作研究者COICoordinatingInvestigator协调研究者CRCClinicalResearchCoordinator临床研究协调者CRFCaseReportForm病历报告表CROContractResearchOrganization合同研究组织CSAClinicalStudyApplication临床研究申请CTAClinicalTrialApplication临床试验申请CTXClinicalTrialExemption临床试验免责CTPClinicalTrialProtocol临床试验方案CTRClinicalTrialReport临床试验报告DSMBDataSafetyandmonitoringBoard数据安全及监控委员会EDCElectronicDataCapture电子数据采集系统EDPElectronicDataProcessing电子数据处理系统FDAFoodandDrugAdministration美国食品与药品管理局FRFinalReport总结报告GCPGoodClinicalPractice药物临床试验质量管理规GCPGoodLaboratoryPractice药物非临床试验质量管理规GMPGoodManufacturingPractice药品生产质量管理规IBInvestigator’sBrochure研究者手册ICInformedConsent知情同意ICFInformedConsentForm知情同意书ICHInternationalConferenceonHarmonization国际协调会议IDMIndependentDataMonitoring独立数据监察IDMCIndependentDataMonitoringCommittee独立数据监察委员会IECIndependentEthicsCommittee独立伦理委员会INDInvestigationalNewDrug新药临床研究IRBInstitutionalReviewBoard机构审查委员会IVDInVitroDiagnostic体外诊断IVRSInteractiveoiceVResponseSystem互动语音应答系统MAMarketingApproval/Authorization上市许可证MCAMedicinesControlAgency英国药品监督局MHWMinistryofHealthandWelfare日本卫生福利部NDANewDrugApplication新药申请NECNewDrugEntity新化学实体NIHNationalInstitutesofHealth国家卫生研究所（美国）PIPrincipalInvestigatorPLProductLicensePMAPre-marketApproval(Application)PSIStatisticiansinthePharmaceuticalIndustryQAQualityAssuranceQCQualityControlRARegulatoryAuthoritiesSASiteAssessmentSAESeriousAdverseEventSAPStatisticalAnalysisPlanSARSeriousAdverseReactionSDSourceData/Document/SDSubjectDiarySFDAStateFoodandDrugAdministrationSDVSourceDataVerificationSELSubjectEnrollmentLogSISub-investigatorSISponsor-InvestigatorSICSubjectIdentificationCodeSOPStandardOperatingProcedureSPLStudyPersonnelListSSLSubjectScreeningLogT&RTestandReferenceProductUAEUnexpectedAdverseEventWHOWorldHealthOrganizationWHO-ICDRAWHOInternationalConferenceofWHODrugRegulat