|
所在平台: Udemy |
课程主页: https://www.udemy.com/course/clinical-research-for-medical-devices/
课程评论：没有评论
**课程名称：** 医疗器械临床研究 **课程概述：** 本课程旨在将医疗器械临床试验中复杂繁琐的法规和方法，以简洁明了的方式进行概述，总时长约一小时。课程将涵盖通用临床实践（GCPs）以及在包括美国在内的全球范围内管辖临床试验的法规，例如美国联邦法规21 CFR第50、56和812部分以及ICH指导原则。 **课程亮点：** * **高效入门：** 适合想要快速掌握医疗器械临床试验基础知识的新入职人员，帮助他们迅速进入工作状态。 * **知识提升：** 能够帮助现有的临床研究助理（CRAs）提升专业知识，尤其适合即将参加临床研究认证考试的专业人士。 **目标受众：** * 医疗器械行业新入职人员 * 希望提升临床研究知识的临床研究助理（CRAs） * 对医疗器械临床试验法规和方法感兴趣的人士
This course takes the painfully dry regulations and methods used for clinical trials on medical devices and distills them nicely into a clean overview over the course of an hour. Students will learn about Good Clinical Practices (GCP's) and the regulations that govern clinical trials in the USA and rest of world, such as 21 CFR Parts 50, 56, and 812 and the ICH guidelines. As a "quick hit" to gain knowledge, this course works wonderfully for getting new trainees to hit the ground running. It also serves to increase the knowledge of current Clinical Research Associates, especially those who are soon looking to take a certification exam for clinical research.
