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所在平台: Udemy |
课程主页: https://www.udemy.com/course/clinical-sas/
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课程名称：临床SAS：临床数据管理与分析 课程概述：欢迎参加Uplatz提供的《临床SAS：掌握临床数据管理和分析》课程。临床SAS是由SAS Institute开发的一款软件套件，专门为临床研究组织和制药公司设计，旨在管理、分析和报告临床试验数据。 课程重点内容包括： - 数据管理：SAS临床使用户能够高效管理和整合来自多个来源的临床试验数据，涵盖电子健康记录、病例报告表、实验室数据和患者日记等。 - 统计分析：该软件提供全面的统计工具，用于分析临床试验数据，包括描述性统计、假设检验、回归分析、生存分析等。 - 报告与可视化：SAS临床具备强大的报告和可视化能力，用户能够创建定制化的报告、表格、图形和仪表板，有效传达发现和见解。 - 监管合规：SAS临床旨在满足FDA 21 CFR 第11部分等监管要求，确保数据的完整性、安全性以及符合行业规定。 - 与其他系统的集成：SAS临床可以与临床研究常用的其他系统和平台（如电子数据采集系统、临床试验管理系统和数据仓库）集成。 该课程提供了一个强大而灵活的平台，以管理和分析临床试验数据，帮助研究者和机构优化药物开发流程，做出明智决策，并加快新疗法上市时间。 课程大纲： - SAS临床研究概述 - 临床研究的历史与伦理背景及ICH-GCP指南 - 临床研究的基本文件 - 药物开发 - 临床试验流程与角色 - 临床试验设计 - 临床试验监测 - 临床研究术语词汇表 - 赞助商的责任、研究者及CRC的角色与职责 - 质量保证和质量控制审核 - 不合规、欺诈与不当行为 - 21 CFR第11部分 - 方案理解 - 临床数据管理 - 方案分配 - CRF设计与格式 - 数据管理计划 - 数据管理项目管理 - 检查设计原则 - 实验室数据处理 - 安全数据管理与和解 - 临床数据归档 - 与CRO和SOP合作 课程旨在提供扎实的CDM基础知识，帮助学员在临床研究领域中脱颖而出。
A warm welcome to the Clinical SAS: Mastering Clinical Data Management and Analysis with SAS course by Uplatz.Clinical SAS is a software suite developed by SAS Institute, a leading provider of analytics and business intelligence solutions. SAS Clinical is specifically designed to support the needs of clinical research organizations and pharmaceutical companies in managing, analysing, and reporting clinical trial data.Some key features of Clinical SAS include:Data Management: SAS Clinical enables users to efficiently manage and integrate clinical trial data from multiple sources, including electronic health records, case report forms, laboratory data, and patient diaries.Statistical Analysis: The software provides a comprehensive set of statistical tools for analysing clinical trial data, including descriptive statistics, hypothesis testing, regression analysis, survival analysis, and more.Reporting and Visualization: SAS Clinical offers powerful reporting and visualization capabilities, allowing users to create customized reports, tables, graphs, and dashboards to communicate findings and insights effectively.Regulatory Compliance: SAS Clinical is designed to meet regulatory requirements and standards such as FDA's 21 CFR Part 11, ensuring data integrity, security, and compliance with industry regulations.Integration with Other Systems: SAS Clinical can be integrated with other systems and platforms commonly used in clinical research, such as electronic data capture (EDC) systems, clinical trial management systems (CTMS), and data warehouses.SAS Clinical provides a robust and flexible platform for managing and analysing clinical trial data, helping researchers and organizations streamline the drug development process, make informed decisions, and accelerate time to market for new therapies.Clinical SAS - Course CurriculumSAS Clinical Research OverviewHistorical and Ethical background of Clinical Research and ICH-GCP GuidelinesEssential Documents in Clinical ResearchDrug DevelopmentClinical Trial Process and RolesClinical Trial DesignClinical Trial MonitoringGlossary of Clinical Research TermsResponsibilities of SponsorSite Selection and Responsibilities of Investigator and CRCQA and QC Audit and InspectionNon-Compliance, Fraud and Misconduct21 CFR part 11Protocol UnderstandingClinical Data ManagementProtocol AssignmentCRF Design and FormatCRF Design and Format demoClinical Data StandardsCDM Study Start UpCDM - EDC Setup ConceptCDM - EDC Study Conduct ConceptCDM - EDC Study Conduct Discrepancy ManagementCDM - Discrepancy ManagementData Management PlanProject Management for Data ManagerVendor Selection and ManagementEdit Check Design PrinciplesEDC Study CloseoutCDM Study CloseoutCRF Completion GuidelinesDatabase Validation and ProgrammingLaboratory Data HandlingExternal Data TransferPatient Reported OutcomeInvestigator MeetingMetrics in CDMAssuring Data QualityMeasuring Data QualitySafety Data ManagementSafety Data ReconciliationMedical CodingClinical Data ArchivingData Entry and ProcessingRole and Responsibilities of CDMMedical Device TrialsClinical Research Q and AClinical Data Management Q and AClinical Research CDM Fundamental Q and AWorking with CROs and SOPsCDISC - part 1CDISC - part 2
