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所在平台: Udemy |
课程主页: https://www.udemy.com/course/clinical-research-real-world-evidence-rwe-professional/
课程评论：没有评论
课程名称：临床研究与真实世界证据（RWE）专业 课程概述： 本课程结合了临床研究的严格性与真实世界证据的创新，旨在解锁真实世界数据的潜力，彻底改变基于证据的医疗决策。无论您是医疗专业人员、研究人员还是数据科学家，本课程都将使您能够驾驭全球临床试验和RWE生成的复杂性，提供SAS、R、CDISC标准、EDC系统、Power BI等工具的实践经验。 您将在本课程中学习到： - 临床研究的基本原理及证据等级 - 临床试验阶段及适应性设计的全面了解 - 全球监管框架：国际协调会议良好临床实践（ICH-GCP）、美国FDA、欧洲药品管理局（EMA）及印度Y计划 - 使用CDASH、SDTM和ADaM标准进行临床数据管理 - 配置领先的电子数据捕获（EDC）系统 - 从电子病历（EMR）、索赔、注册和可穿戴设备中获取真实世界数据 - 设计具备高级混杂控制方法的健全RWE协议 - 使用SAS和R进行生物统计分析（多变量、生存、事件时间分析） - 通过专业仪表板和期刊式报告传达见解 - 准备RWE进行监管提交、标签扩展和市场准入 - 确保在RWE实践中的伦理、数据隐私及全球合规性 - 将药物警戒和信号检测整合到真实世界研究中 - 使用敏捷项目管理技能领导跨职能RWE项目 - 完成一个完整的、经过同行评审的顶点项目，从协议制定到展示 本课程提供与全球行业标准和监管期望相一致的理论与实际相结合的培训，确保您能够提供影响临床、监管及支付方决策的证据，适应当今动态的医疗环境。
Clinical Research & Real-World Evidence (RWE) ProfessionalUnlock the power of real-world data and revolutionize evidence-based healthcare decisions. This internationally benchmarked course blends the rigor of clinical research with the innovation of real-world evidence, offering in-depth mastery from study design to regulatory-grade analysis.Whether you're a healthcare professional, researcher, or data scientist, this course empowers you to navigate the complexities of global clinical trials and RWE generation with hands-on experience in SAS, R, CDISC standards, EDC systems, Power BI, and more.What You'll Learn inside This Course:Fundamentals of clinical research and the hierarchy of evidenceComprehensive understanding of clinical trial phases and adaptive designsGlobal regulatory frameworks: ICH-GCP, FDA, EMA, and Indian Schedule YClinical data management using CDASH, SDTM, and ADaM standardsConfiguring leading Electronic Data Capture (EDC) systemsReal-world data sourcing from EMRs, claims, registries, and wearablesDesigning robust RWE protocols with advanced confounding control methodsBiostatistical analysis using SAS and R (multivariate, survival, time-to-event)Communicating insights via professional dashboards and journal-style reportsPreparing RWE for regulatory submission, label expansion, and market accessEnsuring ethics, data privacy, and global compliance in RWE practicesIntegrating pharmacovigilance and signal detection into real-world studiesLeading cross-functional RWE projects with agile project management skillsCompleting a full-scale, peer-reviewed capstone project from protocol to presentationThis course offers applied theoretical real-world training aligned with global industry standards and regulatory expectations - ensuring you're equipped to deliver evidence that influences clinical, regulatory, and payer decision-making in today's dynamic healthcare environment.
