A written deion of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical deion, presentations, and analyses are fully integrated into a single report (see the ICH Guideline for Structure and Content of Clinical Study...
IDM Independent Data Monitoring独立数据监察 IDMC Independent Data Monitoring Committee独立数据监察委员会 IEC Independent Ethics Committee独立伦理委员会 INDInvestigational New Drug新药临床研究 IRB Institutional Review Board机构审查委员会 IVD In Vitro Diagnostic体外诊断 IVRS Interactive Voice Response System互动语音...
IDMC Independent Data Monitoring Committee独立数据监察委员会 IEC Independent Ethics Committee独立伦理委员会 INDInvestigational New Drug新药临床研究 IRB Institutional Review Board机构审查委员会 IVD In Vitro Diagnostic体外诊断 IVRS Interactive Voice Response System互动语音应答系统 ...
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datamustuseXXXanalysisplanshouldbeXXXanalysis。Ifa mid-termanalysisisneeded。XXXoftreatmenteffectsshould considerboththeconfidenceintervalandtheresultsofXXX。 unused。orndantdataXXXreportoftheclinicaltrialmustmatch thesummaryreportoftheclinicaltrial. Chapter10:ManagementofXXX Article56:XXXproductsusedinclinicaltrials...
(Application) PSI Statisticians in the Pharmaceutical Industry 制药业统计学家协会 QA Quality Assurance 质量保证 QC Quality Control 质量限制 RA Regulatory Authorities 监督治理部门 SA Site Assessment 现场评估 SAE Serious Adverse Event 严重不良事件 SAP Statistical Analysis Plan 统计分析方案 SAR Serious ...
IDM Independent Data Monitoring独立数据监察 IDMC Independent Data Monitoring Committee独立数据监察委员会 IEC Independent Ethics Committee独立伦理委员会 INDInvestigational New Drug新药临床研究 IRB Institutional Review Board机构审查委员会 IVD In Vitro Diagnostic体外诊断 IVRS Interactive Voice Response System互动语音...
PSI:Statisticians in thePharmaceutical Industry 制药业统计学家协会 Q QA:Quality Assurance 质量保证 QC:Quality Control 质量控制 R RA:RegulatoryAuthorities 监督管理部门 S SA:Site Assessment 现场评估 SAE:Serious Adverse Event 严重不良事件 SAP:Statistical AnalysisPlan 统计分析计划 ...
Require that participants be given any additional information that will assist them in making an informed decision to take part in research. (Requirements for informed consent are covered in the Informed Consent module). 要求向参与者提供任何其他信息,以帮助他们做出是否参与研究的明智决定。(知情同意模块...
(fileData) { parts.push({ fileData, }); } if (prompt) { parts.push({ text: prompt, }); } // Add user's environment context to the prompt parts.push( { text: "Replace the placeholders with the following values if they should be present " + "in the output YAML unless the ...