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所在平台: Udemy |
课程主页: https://www.udemy.com/course/good-clinical-practice-ich-gcp-e6-r2/
课程评论：没有评论
本课程是关于ICH GCP E6 R2的综合性学习。课程旨在帮助学员理解什么是良好的临床实践（GCP），以及如何进行合乎道德和安全的临床试验。 **课程亮点：** * **内容详实且易于理解：** 讲师能够将大量的专业信息以详细但不失清晰的方式呈现，学习体验流畅。 * **实践性强：** 课程不仅仅是理论讲解，还包括对ICH GCP E6文件条款的实际操作演示。 * **适合不同水平的学习者：** 无论是初学者还是希望巩固知识的专业人士，都能从中受益。 * **课程结构良好：** 采用循序渐进的方式，将任务分解为易于管理的小环节，便于吸收。 * **互动性学习：** 提供随堂测验和练习，帮助巩固理论知识。 **课程内容涵盖：** * 国际协调会议（ICH）的介绍，包括其成立、宗旨和重要性。 * ICH的运作模式和工作组。 * 有效性指南。 * 什么是良好的临床实践（GCP）以及ICH与GCP的关系。 * 机构审查委员会（IRB）、研究者、申办者、临床试验方案、方案修订、研究者手册、临床试验基本文件等核心概念。 * 通过案例研究来加深对理论知识的理解。 **讲师：** Warda Naz，一位在行业内拥有超过10年经验的资深专家。 **目标学员：** 任何对ICH GCP E6文件感兴趣的人，或希望提升临床研究技能的现有专业人士。 **课程要求：** 无。只需保持开放的心态和学习的意愿。
***Why this course is considered as a TOP RATED and BEST SELLING course for the ICH GCP category on Udemy?***See what students are talking about in this course:5***** Star RatingI'm very glad I enrolled in this class! There's so much information to be absorbed and she did a great job in presenting everything in as much detail as possible, but at the same time simplifying it to make your learning experience a lot smoother. This is a great course if you're just starting out and want to know the fundamentals of GCP. This master class has it all! --Devon Roman5***** Star RatingShe is a great instructor, very transparent, cuts out all the BS getting straight to the meat and potatoes of the subject at hand, exactly how I like to learn.I am happy about investing in this course. The videos are over the shoulder at the right pace explaining the process of understanding the clauses.The course has left me feeling confident that I can achieve my goals, plus I had so much fun learning.If you create any more courses, you have a repeat customer in me.-- Rebecca5***** Star RatingVery well constructed course covering all the topics I was interested in. Really liked the step-by-step approach and tasks broken into manageable chunks, allowing me to absorb the information. The tutor was great, the notes were very helpful and I made a lot of use of the Quizzes and Assignments section.Highly recommend the course for either a beginner or someone with some experience but a bit rusty (such as me).-- Reshma 5***** Star RatingShe is an amazing teacher, the best I could find so far. She is knowledgeable, explains very well, has a nice and soothing voice, and has a great sense of presentation.The course is also more hands-on than a lot of other courses where you practically just watch guys read. She explains clauses practically who ICH GCP E6 document.If you want to learn and understand GCP or clinical research in general, this is a great place to start.-- Varun P5***** Star RatingThis is an excellent, cost-effective, and comprehensive course and I'm so glad to enroll in the class. Plus, I've learned so much from the basics that have been taught. I'm so grateful to have the instructor spending time to develop this course and share knowledge. Again, thanks, and this course is highly recommended!-- Dennis Clayton5***** Star RatingThe content was helpful and this was a nice quick review.-- Ayesha A. Rizvi, Ed.D.5***** Star RatingThe information is explained in a detailed manner-- Monique Brown5***** Star RatingBravo-- Tshering JAMTSHO----------------------------------------------COMPLETE COURSE DESCRIPTION:Welcome to the complete ICH Good Clinical Practices E6 R2 course.In this course, we will learn what Good clinical practices are, guidelines of what an ethical and safe trial is, the rights and importance of consent of the trial subjects, the duties of the sponsor and investigator of the trial, and much more. Basically, I will walk you through the entire GCP guidelines document step by step.My name is Warda Naz, and I will be leading you through this course.Here at Magine Solutions highly experienced instructors, engineers, and doctors with more than 10 years of experience in the industry will guide you through very high-quality online courses.At the end of the course, you will be able to understandWhat is International Council for harmonization?Aims of ICHHow was ICH established?The importance of ICH.Groups working within ICHEfficacy GuidelinesWhat are Good clinical Practices (GCP)?The link between ICH and GCPAll about the Institutional review board, investigators, sponsors, clinical trial protocol and protocol amendment, investigator's brochure, essential documents for the conduct of a clinical trial, and much more.We will also learn to understand these concepts by looking at case studies to strengthen the theoretical concepts.The ideal student for this course is anyone who wants to learn about the ICH GCP E6 document or an existing professional who wants to expand on their current skills. There are no requirements necessary to enroll. I only ask to come open-minded and ready to learn.Feel free to take a look at the course description and I look forward to seeing you inside. Thank you!!----------------------------------------------
