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所在平台: Udemy |
课程主页: https://www.udemy.com/course/clinical-data-management-course-2023/
课程评论：没有评论
**课程名称：** 2025临床数据管理课程 **课程概述：** 本课程全面深入地介绍了临床数据管理（CDM）这一临床研究的关键环节。CDM团队贯穿临床试验的各个阶段，从启动到完成，确保生成高质量、可靠且统计可靠的数据，从而显著缩短新药的研发上市周期。 课程将涵盖CDM的各个方面，包括： * **基础知识：** CDM简介、术语表（Glossary -1, -2）、CDM指南。 * **核心流程：** 数据管理计划（DMP）、CDM整体流程、研究文档的审阅与定稿。 * **数据库与数据收集：** 数据库设计、数据收集与病例报告表（CRF）跟踪、CRF的设计与开发、CRF的处理与现场库存管理。 * **数据录入与质量控制：** 数据录入、数据验证、不一致项管理（Discrepancy Management）、医学编码（Medical Coding）。 * **后续环节：** 数据库锁定、质量保证/质量控制（QA/QC）检查、数据存储与归档。 * **行业相关：** CDM工具、CDM中的角色与职责，以及其他相关信息。 **重要性与趋势：** 在当今快速发展的药物研发环境中，提升CDM标准以满足法规要求并加速产品商业化至关重要。本课程强调行业对更高CDM标准的需求，尤其是在电子数据提交日益普及的背景下。CDM专业人员需要具备适应快速技术变革的能力，以满足对数据质量的期望和设定的标准。 **总结：** 本课程旨在为学习者提供CDM流程的全面概述，介绍所采用的工具和标准，并阐明CDM团队的关键角色与职责，帮助他们在快速变化的行业环境中取得成功。
Below topics will cover in this Course: - Introduction of CDM - Glossary -1 - Glossary -2 - Guidelines for CDM - Data Management Plan - CDM Process - Review and Finalization of study documents - Database designing - Data collection & CRF tracking - Development /design of CRF - CRF Processing & Inventory from site - Data Entry - Data Validation - Discrepancy Management - Medical Coding - Database locking - QA/QC checks & Data storage and Archival - Tools for CDM - Roles & Responsibility in CDM - Additional Information related to CDMClinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. Team members of CDM are actively involved in all stages of clinical trial right from inception to completion. They should have adequate process knowledge that helps maintain the quality standards of CDM processes. Various procedures in CDM including Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a trial. In the present scenario, there is an increased demand to improve the CDM standards to meet the regulatory requirements and stay ahead of the competition by means of faster commercialization of product. With the implementation of regulatory compliant data management tools, CDM team can meet these demands. Additionally, it is becoming mandatory for companies to submit the data electronically. CDM professionals should meet appropriate expectations and set standards for data quality and also have a drive to adapt to the rapidly changing technology. This article highlights the processes involved and provides the reader an overview of the tools and standards adopted as well as the roles and responsibilities in CDM.
