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所在平台: Udemy |
课程主页: https://www.udemy.com/course/good-clinical-practice-for-medical-writers-from-e6-to-e3-gcp/
课程评论：没有评论
**课程名称：** 医务撰写人员的良好临床实践（GCP）：从E6到E3 **课程概述：** 本课程专为希望提升临床撰写技能和GCP知识的医务撰写人员设计。课程内容涵盖ICH GCP E6（R3）的核心要点，并深入探讨ICH GCP E3（步骤5）。课程基于ICH GCP E6（R3）框架原则，旨在为医务撰写人员提供全面理解GCP的教育解决方案。GCP是确保临床试验完整性、质量和可信度的伦理和科学标准，对医务撰写人员有效沟通和报告临床试验结果至关重要。 课程将深入讲解GCP原则，重点介绍ICH GCP E6（R3）作为扎实的基础，随后详细探讨ICH GCP E3（步骤5）及临床试验文档的关键方面。课程特别强调为医务撰写人员量身定制，专注于他们需要严格按照GCP标准生成的特定文档，并通过实际案例和互动学习方式进行强化。 **重点内容：** * GCP原则（E6 R3）介绍 * ICH GCP E6（R3）关键概念 * ICH GCP E3 深度分析 * 临床研究中研究报告（CSR）的角色 * CORE：紧跟新兴趋势 **重要提示：** 本课程不提供官方GCP认证。根据法规要求，官方认证需要每两年更新一次，所有参与临床试验活动的人员，特别是直接接触患者的人员（如协调员、现场人员和监查员），都必须进行此强制性再认证。此外，部分申办方可能要求其自身的GCP培训计划，即便您拥有其他来源的有效认证，也可能需要完成其培训。
Are you a medical writer ready to enhance your skills and understanding of Good Clinical Practice (GCP)? This course is designed specifically for medical writers like you!Elevate your clinical writing skills with this in-depth course covering from ICH GCP E6 (R3) essentials to an immersive exploration of ICH GCP E3 (Step 5).It is based upon the principles delineated in the ICH GCP E6 (R3) framework, tailored to serve as an educational solution to the needs of medical writers seeking to acquire a comprehensive understanding of Good Clinical Practice (GCP).Good Clinical Practice (GCP) is the ethical and scientific standard that ensures the integrity, quality, and credibility of clinical trials. As a medical writer, mastering GCP is key to effectively communicate and report clinical trial findings.The course is crafted to provide you with a deep understanding of GCP principles, with a special focus on ICH GCP E6 (R3) for a solid introduction. We then take a detailed exploration into ICH GCP E3 (Step 5) and critical aspects of clinical trial documentation.Of particular emphasis is the training's targeted orientation toward the specific documents that medical writers are tasked with generating in strict accordance with GCP standards. This orientation is fortified by practical models and an interactive learning approach.Key Sessions:· Introduction to GCP Principles E6 (R3)· ICH GCP E6 (R3) - Key Concepts· ICH GCP E3 - In-depth Analysis· The Role of CSRs in Clinical Research· CORE: stay updated with emerging trendsIt is worth noting, however, that this training does not confer an official certification, which, as per regulatory stipulations, necessitates biennial renewal. Such recertification is mandatory for all individuals engaged in clinical trial activities, particularly those interfacing directly with patients, such as coordinators, site personnel, and monitors.Furthermore, it is important to acknowledge that certain sponsors may mandate their own GCP training program, which could require participants to undertake it even if they possess a currently valid certification from another source.
