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所在平台: Udemy |
课程主页: https://www.udemy.com/course/good-clinical-practice-ich-gcp-for-clinical-investigators/
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**课程名称：** 临床试验研究者和机构人员良好临床实践 (Good Clinical Practice for Investigators and Site Personnel) **课程概述：** 本课程基于ICH-GCP (R2) 版本，专为临床试验研究者、协同研究者、研究协调员及其他需要掌握良好临床实践 (GCP) 知识以成功执行临床试验的机构人员设计。课程提供ICH-GCP (R2) 及后续修订版本的终身访问权。 讲师Dr. Vincent Baeyens拥有超过20年的全球及中型制药和生物技术公司临床试验经验，将重点讲解研究者的关键ICH-GCP要求及职责。通过本课程，学员将建立坚实的基础，为顺利通过机构的ICH-GCP法规检查和审计做好准备。 **学习内容：** * **GCP的定义和重要性：** 理解GCP是什么及其在临床研究中的关键作用。 * **赫尔辛基宣言与GCP的联系：** 了解两者之间的关系。 * **关键术语和概念：** 掌握临床研究中使用的核心定义，包括相关方和关键流程。 * **ICH-GCP原则及实践应用：** 学习GCP原则，并获得如何在临床试验中实际应用的建议。 * **研究者的详细职责：** 全面了解研究者在试验期间的各项职责，包括资质要求、遵循方案、与伦理委员会的沟通、安全性报告和最终报告等。 * **常见GCP审计和检查发现及规避：** 认识临床试验中常见的GCP审计和检查问题，并学习如何避免这些问题（课程更新强调了这一点）。 课程包含测验以巩固知识。欢迎学员查阅课程内容并与讲师交流。
[February 2023]: Added awareness of the most common GCP findings (lecture 4)[January 2023]: Edited English subtitles, adding French subtitles--Welcome to the edition of the ICH-GCP (R2) course for Clinical Investigators & Other Site Personnel!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 a ICH-GCP (R2) course for Investigators, Co-investigators, Study Coordinators, and any other Clinical Study staff requiring knowledge in GCP for a successful execution your clinical trials at Clinical Sites.It provides full lifetime access to GCP Revison 2, and all subsequent Revisions of the GCP by the 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.This course is based on my experience of the key ICH-GCP requirements to conduct a clinical study as an Clinical Investigator and study site personnel. We will review the role and responsibilities of the Investigators.This course will provide you with a strong foundation to prepare for successful site regulatory ICH-GCP inspections and audits.I will lead you step-by-step through the ICH-GCP E6 with a focus on Investigators responsibilities.You will learn and 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 and key processes involved The ICH-GCP Principles and practical advices to apply them in your clinical trialsThe detailed responsibilities of the Investigator throughout the trial, including qualifications, compliance to protocol, communication with Ethics Committees, safety reporting, and final reportingThe common ICH-GCP audit and inspection findings in clinical trials and how to avoid themQuizzes 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!I am looking forward to seeing you inside the course!Sincerely,Vincent
