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所在平台: Udemy |
课程主页: https://www.udemy.com/course/good-clinical-practice-for-clinical-research-professionals/
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课程名称：临床研究专业人员的良好临床实践 课程概述：本课程是最新的 ICH GCP 课程的完整版本，旨在为需要了解良好临床实践 (GCP) 的研究人员、研究协调员、赞助商、临床项目经理、监测人员及其他临床研究工作人员提供基础知识。课程内容包括最新的 ICH-GCP (R3) 相关更新，覆盖了多个重要概念及其实际应用。 更新内容包括： - 2024年6月，添加了 ICH-GCP (R3) 附录2概念文件。 - 2024年1月，更新了附赠部分，包含针对ICH E6 (R3) 的评论概览。 - 2023年9月，更新了ICH GCP R3草案原则部分并添加相关文档资源。 - 2023年6月，新增 DRAFT ICH GCP (R3) 附录1（干预临床试验）及其变更摘要。 - 2023年5月，增加了质量管理的ICH E8 (R1) 资源链接。 - 此外，课程中还提供了关于常见GCP发现的意识、实用风险评估作业以及来自FDA检查案例的实践练习等内容。 课程由拥有20年以上全球及中型制药和生物技术行业经验的 Vincent Baeyens 博士主讲，旨在帮助学员理解和掌握设计、实施、记录和报告临床试验所需的关键ICH GCP要求。课程将逐步阐述 GCP 的原则及伦理委员会的职责，教授如何撰写合适的研究方案和依从性材料，以及有效的调查员手册编写方式。 课程特色： - 通过小型讲座分段教学，适合初学者的学习需求。 - 高级学员可调节讲座播放速度以适应个人学习节奏。 - 提供知识测试小测验及最终测验巩固学习成果。 - 课程结束后可与专家进行一小时的问答互动，解决学习中的疑问。 欢迎您查看课程内容，期待在课程中见到您！
Updates:June 2024: Added ICH-GCP (R3) Annex 2 concept paperJanuary 2024: Updated Bonus section; added the ICH-GCP (R3) Overview of comments received on Step 2. Comments will now be sent to the ICH E6 (R3) Expert Working Group for consideration in the context of Step 3 of the ICH process.September 2023: Updated section of ICH GCP R3 Draft Principles and added resource documentationAugust 2023: Added list of Acronyms and Abbreviations used in the course (section 1)June 2023: Added DRAFT ICH GCP (R3) Annexe 1 (interventional clinical trials), its summary of changes and explanatory video in the resources. This version is made available by the ICH for public consultation until September 2023 (step 2 of the ICH process)May 2023: Added link to ICH E8 (R1) in resources of quality managementFebruary 2023: Added awareness of the most common GCP findings (lecture 4)January 2023: Edited English subtitles, adding French subtitlesDecember 2022: Added assignment: Practical risk assessment based on UK MHRA inspection report (section 11)October 2022: Added assignment: Practical exercises from real FDA inspection cases (section 10)September 2022: Added updates on ongoing development of Revision 3 of ICH-GCP (section 12)-Welcome to the only up-to-date, complete edition of the ICH GCP course!This course meets the Minimum Criteria for ICH E6 (R2) GCP Investigator and Site Personnel Training that TransCelerate has identified as necessary to enable mutual recognition of GCP training.This course offers the first professional, fundamental on-line ICH GCP (R2) detailed course for Investigators, Study Coordinators, Sponsors, Clinical Project Managers, Monitors and any other Clinical Study staff requiring knowledge in GCP for a successful execution your clinical trials. This ICH-GCP course also presents elements of ICH GCP E6 (R3) as they become available currently under revision by ICH.My name is Dr. Vincent Baeyens PhD, I have more than 20 years of experience in running Clinical Trials in Global and mid-size Pharma, and Biotech settings. I have worked with most of the Global as well as several niche CROs and I am also an expert in CRO Management and Oversight, budgeting and Risk Management. In this course, you will be able to understand based on my experience the key ICH GCP requirements to design, conduct, record and report clinical trials in humans from A to Z. We will review the role and responsibilities of the key stakeholders and the structure of the essentials documents.To facilitate the learning of beginner students, the course has been broken up on purpose in several small lectures.Note: If you are a more advanced student, you can increase the speed of lecture to learn the course at your own pace.This course will provide you with a strong support to prepare for successful regulatory ICH GCP inspections and audits.I will lead you step-by-step through the ICH GCP E6, and you will learn & understand:What is GCP and why GCP is important in clinical researchThe link between the Declaration of Helsinki and current GCPThe definition of the key definitions of terms and concepts used in clinical research, including stakeholders involved and essential documentsThe ICH GCP Principles of Revision 2 and Revision 3 and practical advices to apply them in your clinical trialsThe responsibilities of ethics committees, its composition, function, operational aspects and obligationsThe detailed responsibilities of the Investigator throughout the trial, including his/her qualifications, compliance to protocol, communication with Ethics Committees, safety reporting, and final reportingHow to write an adequate Protocol / protocol amendment and rationale for its structureThe What, the Why and the How for an effective writing of the Investigator's BrochureThe purpose of Essential Documents in clinical research: How and Where to file them in the Trial Master File (TMF)The common ICH GCP audit and inspection findings in clinical trials with practical exercises (FDA, MHRA)I will illustrate the GCP concepts with several practical tips & tricks , so that you will be able to apply ICH GCP to your daily practice from Day 1!Quizzes are proposed to test your knowledge along your journey. A final Quiz at the end of the course will consolidate your knowledge.Feel free to look at the content of the course to know more and contact me any time if you have any questions!After the course, spend 1 hour with the EXPERT to answer ALL the questions that you would have!! All you have to do is to send me an e-mail with your questions and contact details, and I will set up a call with you.I am of course available personally during the course as well to answer your questions or comments!I am looking forward to seeing you inside the course!Sincerely,Vincent
