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所在平台: Udemy |
课程主页: https://www.udemy.com/course/certificate-course-in-clinical-research-cccr/
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课程名称：临床研究证书课程（CCCR） 课程概述：如果你觉得临床研究领域具有挑战性，那么这个课程正是为你量身定制的。制药行业是一个受到高度监管的领域，拥有许多政府法规以保护公众健康。因此，制药行业的重要目标是开发符合监管要求的药品。药物开发、制造、营销和销售的监管涉及相互矛盾的目标：一方面，确保安全有效的药物迅速到达公众；另一方面，又要防范无效、不安全或有害的治疗。本课程将帮助你深入理解药物开发过程、临床研究及相关文件、临床试验的良好实践、主要参与者的角色和责任等内容，从而帮助你在临床研究领域的职业发展。 课程内容包括： - 临床研究的基本概念 - 临床研究的主要参与者 - 美国药品法规的历史背景 - 药物审批流程 - 新药开发的前临床步骤 - 调查新药申请（INDA） - 新药申请（NDA） - 简略新药申请（ANDA） - 重要文档 - 研究方案 - 来源文档 - 知情同意书 - 研究者手册 - 病例报告表（CRF） - 纳入与排除标准 - 赞助者、研究者、临床研究助理（CRA）和临床研究协调员（CRC） - 临床研究专业人士的重要文献搜索网站 - 等等... 课程还包含多个可下载的文档，供你随时参考。有许多常见问题，帮助你在准备临床研究面试时更为顺利。此外，本课程还包括一个名为“会议礼仪”的附加课程，强调在参加或主持会议时应考虑的重要事项。 此课程包含30多个信息丰富的教学视频，格式简明易懂，逐步带你了解临床研究及相关活动。"质量改善是一个持续终身的过程"。完成这门课程后，你将成为一个具备更高临床研究知识的专业人士，从而获得团队成员、经理、客户等的更多尊重。
If you find the Clinical Research field challenging, well, in that case, this is the best course for you.The pharmaceutical industry is one of the extremely regulated industries, with several government regulations to protect public health. Therefore, the important target of the pharmaceutical industry is to develop a Drug product passing the regulatory requirements. On the other hand, regulation of drug development, manufacturing, marketing, and sales involves paradoxical objectives. It must ensure that safe and effective pharmaceutical formulations reach the public quickly while concurrently protecting against ineffective/unsafe/harmful therapies. This course will provide you with a strong understanding of the Drug development process, Clinical Research and related documents, GCP, Roles, and responsibilities of major players in Clinical Research in a summarized manner which will help to work towards shaping your career in Clinical Research.This course focuses on the following points that could make Clinical Research activities smooth without any significant delays/failures,• Basic Understanding of Clinical Research,• Major players in Clinical Research,• Historical background of US Drug Law and Regulations,• Drug Approval Process,• New Drug Development-Preclinical Steps• Investigational New Drug Application (INDA),• New Drug Application (NDA),• Abbreviated New Drug Application (ANDA),• Essential Documents,• Protocol,• Source Documents,• Informed Consent form,• Investigator's Brochure,• Case Report Form (CRF),• Inclusion-Exclusion criteria,• Sponsor,• Investigator,• Clinical Research Associate (CRA) and Clinical Research Coordinator (CRC),• Important Literature Search Websites for Clinical Research Professional,• Many more...There will be several downloadable documents so that you can follow along with them whenever you need them.This course contains Commonly Asked Questions that will help you while preparing for Clinical Research interviews.Last but not the least, this course also contains a bonus course entitled "Meeting etiquettes" which will help you to shape your career in which the points that must be taken into consideration while attending/conducting meetings are covered.In this course, more than 30 informative videos are included and are designed in an easily digestible format and going to take you through step by step approach to understand Clinical Research and relevant activities.I believe "Quality improvement is a continuous and lifetime process". Upon completion of this course, you will be a whole different professional with improved Clinical Research knowledge which will help you to garner more respect from your team members, managers, clients, or anyone with whom you are communicating/interacting.
