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所在平台: Udemy |
课程主页: https://www.udemy.com/course/quality-risk-management-in-clinical-trials/
课程评论：没有评论
**课程名称：** 临床试验中的质量风险管理 **课程概述：** 本课程为期1小时的基础培训，旨在帮助学员理解和实施质量风险管理（QRM），以确保受试者的安全和临床试验结果的可靠性。完成本课程后，您将能够： * 理解质量风险管理（QRM）的原则（这是其成功的关键标准）、目标以及如何在临床研究环境中实现这些目标。 * 了解如何根据ICH GCP E6（R2）的要求识别、评估、优先排序和控制风险。 * 认识到风险管理是一个迭代过程，始终牢记新知识和分析可以导致对评估过程以及已实施的行动和控制措施进行修订。 **课程形式：** 本培训课程包括自动配音的视频教程。完成所有课程讲座后，您将需要参加一次在线考试，考试包含选择题。课程不包含案例研究。
The purpose of this 1-hour basic training is to facilitate the understanding and implementation of the Quality Risk Management (QRM) to ensure the protection of human subjects and the reliability of clinical trials results.After completing ths online course you should be able to:Understand Quality Risk Management (QRM) principles (which are the key criteria for its success), goals, and how to achieve those goals in the Clinical Research setting.Know how to identify, evaluate, prioritize and control risks according to ICH GCP E6 (R2).Comprehend Risk Management is an iterative process, keeping always in mind that new knowledge and analysis can lead to a revision of the assessed proceses and actions and controls implemented.The training course consists of automatically narrated video tutorials. Once you complete all the course lectures you will be requested to take an online exam which consists of multiple-choice questions.Case studies are not part of the training.
