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所在平台: Udemy |
课程主页: https://www.udemy.com/course/certification-course-in-clinical-research-cdm-pv/
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课程名称：临床研究、临床数据管理与药物安全的高级认证课程 课程概述： 本课程非常适合对药物开发过程感到好奇，并希望在临床研究领域寻求职业发展的学员。制药行业受到众多政府监管，以保障公众健康，这使其成为一个高度规范化的行业。在制药行业中，满足监管要求并成功市场化药物或医疗产品是关键目标，这一目标通过开展临床试验来实现。临床研究是医学研究的一种形式，旨在通过研究人群来理解健康与疾病的关系。临床研究有助于改善医生的治疗与预防方法。通过临床研究，研究人员能够了解药物在人体内的作用、疾病的演变过程、身体如何处理潜在治疗及疾病的治愈方法、哪些行为有助于保持健康以及哪些行为增加患病风险。其目标是利用科学来持续改善人们的医疗和健康。 参加临床研究的参与者可能会获得自身的益处，也可能不会。通过本课程，您将对药物开发过程、临床研究及相关文档、良好临床实践（GCP）以及临床研究关键参与者的角色与职责有全面的了解。 课程涵盖的主题包括： - 临床研究介绍 - 临床研究历史 - 《赫尔辛基宣言》 - 《纽伦堡原则》与医学伦理 - 良好临床实践（GCP） - ICG GCP的13项原则 - 国际协调会议（ICH）、内容及重要性 - 术语表 - 临床研究的利益相关者 - 主研究者（PI）的角色与职责 - 赞助商的角色与职责 - 伦理委员会（EC）的角色与职责 - 合同研究组织（CRO）的角色与职责 - 临床研究助理（CRA）、临床研究协调员（CRC）的角色与职责 - 试验对象在临床试验中的角色与知情同意流程 - 注册审查员、统计学家和临床数据经理在试验中的角色 - 临床试验中的监测 - 临床试验设计 - 临床试验中的重要文件 - 临床研究中的职业与机会 - 技能发展与寻求临床研究中的不同职业路径 - 研究者手册与协议 - 临床试验概述 该课程将为您在临床研究领域的职业生涯奠定坚实的基础。
This is the ideal course for you if you find are curious about Drug Development Process and want to explore & seek a career in Clinical Research. In order to safeguard the public's health, the pharmaceutical industry is subject to numerous government restrictions, making it one of the most heavily regulated sectors. Marketing a Drug/Medicinal product that satisfies regulatory criteria is a key goal for the pharmaceutical sector which is achieved through conducting Clinical Trials. Clinical research is medical research that studies people to understand health and disease. Clinical research helps improve the way doctors treat and prevent illness. Through clinical research, researchers learn about important as aspects of the medicine such as How the Drug Works in the human? How illness develops in people, such as how diseases get better or worse over time? How the body handles a possible treatment & cures of the disease, Which behaviors help people stay healthy and prevent illness, and which behaviors raise the chance of illness The goal is to use science to improve people's health care and health over time. The participants who join and take part in clinical research studies may or may not get any benefit for themselves.You will gain a solid understanding of the drug development process, clinical research and related documentation, GCP, and the roles and duties of key clinical research players in a condensed form from this course.Topics covered in this course are:- Introduction to Clinical Research- History of Clinical Research- Declaration of Helsinki- Nuremberg Code & Medical Ethics- Good Clinical Practices (GCP)- 13 Principles of ICG GCP- ICH, Contents & it's Importance.- Glossary terms- Stake Holders in Clinical Research- Roles & Responsibilities of PI- Roles & Responsibilities of Sponsor- Roles and Responsibilities of EC- Roles and Responsibilities of Contract Research Organization- Roles & Responsibilities of CRA, CRC- Role of Subject in Clinical Trials & Inform Consent process- Role of RA, Biostatistician & Clinical Data Manger in trials- Monitoring in Clinical Trials- Clinical Trial Design- Essential Documents in Clinical Trials- Careers & Opportunities in Clinical Research- Skill Development & Seeking various Careers in Clinical Research- Investigator's Brochure & Protocol- Clinical Trial overview
