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所在平台: Udemy |
课程主页: https://www.udemy.com/course/clinical-data-management/
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课程名称：临床数据管理概述 课程概述： 本课程旨在帮助学员简单易懂地了解临床数据管理及其相关流程，以生成高质量的临床试验数据，从而加快产品的商业化进程。通过这个综合性的课程，学员将掌握临床数据管理的基础知识，熟悉CDM的各个阶段及活动，识别CDM中的工具和角色，并学习如何通过CDM活动管理临床数据。临床数据管理对整体研究功能至关重要，其关键成果是支持药物提交的数据。随着制药公司对快速药物开发过程日益增长的需求，以及监管机构对建立质量体系以确保生成高质量数据的要求，CDM不断发展。 课程内容与结构： 本课程专为医疗行业初学者设计，涵盖24个视频讲座，内容时长约2小时，并设有2个模块末测验。第一部分概述临床数据管理，讨论CDM的概念、相关法规及实施标准；第二部分重点介绍CDM过程、数据管理计划，并描述不同数据管理阶段所涉及的活动；第三部分概述CDM中使用的各种工具及CDM团队中关键成员的职责。 课程结束时，学员将能够： - 理解临床数据管理及其在临床研究中的作用 - 描述CDM过程中的各项活动 - 展示CDM中关键成员的职能及可用的多种工具 本课程为希望深入了解临床数据管理方法的学员提供了一个良好的起点。
This course provides an easy understanding of clinical data management and processes involved for generation of high quality clinical trials data that helps in faster commercialization of product Learn Basics Of Clinical Data Management With This Comprehensive Course Get familiar with Clinical data Management Learn Phases & activities in CDM Identify tools & roles in CDM Master to manage clinical data by CDM activities Clinical Data management is essential to the overall research function,as its key deliverable is the data to support the submission. CDM has evolved in response to the ever-increasing demand from pharmaceutical companies to fast-track the drug development process and from the regulatory authorities to put the quality systems in place to ensure generation of high-quality data for accurate drug evaluation. Contents and overview This course is designed to introduce the concept of clinical data management and data management activities for beginners in healthcare industry covering 24 video lectures with 2 hours content & 2 end of module quizzes. Section 1 starts with an overview of clinical data management,discussing what is clinical data management and regulations,standards implemented in CDM. Section 2 outlines CDM process,data management plan and describe activities involved in different phases of data management. Section 3 gives an overview of variable tools used in CDM and key members involved in CDM team with their responsibilities At the end of the course,you will able to Understand clinical data management and it's role in clinical researchDescribe activities involved in CDM processDemonstrate functions of key members in CDM and variable tools available for CDM
