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所在平台: Udemy |
课程主页: https://www.udemy.com/course/learn-advanced-clinical-research-fundamentals-from-scratch/
课程评论：没有评论
**Coursera 课程摘要：从零开始学习临床研究高级基础** 本课程旨在为学习者提供临床研究领域的全面基础知识。课程将详细介绍临床研究的定义、范围、各个分支领域及其职业发展机会。 **核心内容包括：** * **临床研究的历史与规范：** 深入了解塑造临床研究领域的关键历史事件，以及由此产生的各种准则、法规和宣言（例如，涉及研究伦理和保护受试者的相关规定）。 * **临床试验的核心文件：** 掌握进行临床试验所必需的关键文件，包括研究方案 (Protocol)、研究者手册 (Investigator's Brochure)、病例报告表 (Case Report Form) 和知情同意书 (Informed Consent Form) 等。 * **临床研究的关键职能：** 了解临床数据管理、医学写作、临床运营等重要领域的职责和作用。 * **新药发现与开发流程：** 详细解析新药从发现到上市的整个过程，涵盖临床前研究、临床研究以及上市后的监测研究。 * **药理学核心概念：** * **药代动力学 (Pharmacokinetics)：** 深入理解药物在体内的吸收 (Absorption)、分布 (Distribution)、代谢 (Metabolism) 和排泄 (Elimination)。 * **药效学 (Pharmacodynamics)：** 重点阐述药物对身体的作用机制及其产生的响应。 * **审计与检查：** 区分申办方/合同研究组织 (CRO) 对临床试验机构进行的审计 (Audits) 与监管机构（政府部门）进行的检查 (Inspections)，理解其目的和过程。 通过本课程的学习，学员将能够扎实地掌握临床研究的各项基础知识，为未来在该领域的发展奠定坚实基础。
After pursuing this course Learners will understand what is Clinical Research, Its scope, Various domains and careers in Clinical research.Learners will get insights into the various historical events that led to the development of various Codes, Guidelines, Declarations in the field of Clinical Research. Various Essential documents for the conduct of Clinical trial like Protocol, Investigator's Brochure, Case report form, Informed consent form, etc.This course also highlights the importance of Clinical data management, Medical writing, Clinical operations, etc.There is a topic of New Drug Discovery & Development which explains the process of Drug discovery and the development of a Drug such as Pre-clinical research, Clinical research & Post-marketing surveillance studies.There are 2 topics on Pharmacology explaining Pharmacokinetics and Pharmacodynamics in detail.Pharmacokinetics means the movement of Drug in and out of the body i.e. Absorption, Distribution, Metabolism & Elimination of drug.Pharmacodynamics means what a drug does to the body i.e. the response which it creates.There is also a topic on Audits & Inspections.Audits are performed by a Sponsor and/or Contract Research organization at a clinical trial site. Inspections are performed by Regulatory authorities i.e. Governmental bodies in any country where clinical research is conducted.
