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所在平台: Udemy |
课程主页: https://www.udemy.com/course/certificate-course-in-ich-gcp-good-clinical-practice/
课程评论：没有评论
课程名称：良好临床实践 ICH GCP - 完整证书课程 课程概述： 本课程旨在帮助您掌握伦理临床研究的基本原则。通过参加“良好临床实践 ICH GCP - 完整证书课程”，您将深入了解国际协调会议（ICH）关于人用药物技术要求的良好临床实践（GCP）指南。 课程亮点： 1. **核心ICH-GCP原则**：学习ICH-GCP的核心原则，包括对人类受试者的保护、数据完整性以及临床试验的伦理行为，理解全球接受的临床研究要求。 2. **IRB/IEC的角色与职责**：深入了解伦理审查委员会（IRB）/独立伦理委员会（IEC）的角色、组成、功能与运作程序。 3. **研究者的角色与职责**：了解研究者的责任，包括协议遵循、试验的提前中止、医疗护理、安全报告、知情同意及参与结束、研究产品管理、随机化与盲法等。 4. **赞助商的角色与职责**：涵盖赞助商与IRB/IEC的沟通、质量管理、合规性、安全评估与报告、研究产品、数据记录及临床研究报告等。 5. **研究者手册的开发**：学习如何制定研究者手册，包括参考安全信息和风险-收益评估。 6. **临床试验方案及其修订**：了解临床试验方案的内容及修订相关知识。 7. **临床试验必需记录的管理**：学习如何管理临床试验中的必需记录。 为什么选择本课程？ - **行业认可的认证**：获得行业认可的证书，展示您的ICH-GCP专业知识，提升求职竞争力。 - **职业发展**：增强您在临床研究相关岗位的职业前景，获得优质的管理、监控与监管事务知识和技能。 - **全球机会**：ICH-GCP是国际公认的标准，帮助您掌握全球需求的技能，打开国际职业机会的大门。 适合报名对象： - 临床研究助理（CRA） - 临床试验协调员 - 研究者 - 监管事务专业人士 - 对伦理临床研究感兴趣的任何人 不要错过这个机会，全面了解“良好临床实践”，提升您的临床研究职业生涯。立即注册，迈出成为临床研究专业人士的第一步！注意：无须临床研究的先前知识，但建议具备基本的医学术语理解。
Title: Good Clinical Practice ICH GCP - Full Certificate CourseMaster the Principles of Ethical Clinical Research.Are you looking to establish a strong foundation in clinical research ethics and compliance? Enroll in our comprehensive "Good Clinical Practice ICH GCP - Full Certificate Course" to gain an in-depth understanding of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) guidelines.Key Highlights:Essential ICH-GCP Principles: Dive into the core principles of ICH-GCP, including the protection of human subjects, data integrity, and the ethical conduct of clinical trials. Understand the requirements for conducting clinical research that is accepted globally.Roles and Responsibilities of IRB/IEC: Gain insights on Roles and Responsibilities of IRB/IEC, their Composition, Functions and Operations, Procedures, Records, Submission and Communication.Roles and Responsibilities of Investigator: Understand Roles and Responsibilities of an Investigator, Protocol compliance, Premature suspension of trial, Medical care, Safety Reporting, Informed consent & End of Participation, Investigational product management, Randomization & Unblinding.Roles and Responsibilities of Sponsor: Understand Roles and Responsibilities of a Sponsor, Communication with IRB/IEC and Sponsor oversight, Quality management, Non-compliance, safety assessment & reporting, Investigational products, Data/ Records and Clinical study report.Investigator's Brochure: Development of the Investigator's Brochure, Reference Safety Information and Risk-Benefit Assessment, General considerations and Contents of the Investigator's Brochure.Clinical Trial Protocol and its Amendment: Clinical trial protocol and Content of Clinical trial protocol.Essential Records for the conduct of Clinical Trial: Management of Essential Records, Essential Records for All Trials and Potential Essential Records.Why Choose This Course?Industry-Recognized Certification: Earn a certificate that is recognized by the industry, showcasing your expertise in ICH-GCP to potential employers and sponsors.Career Advancement: Enhance your career prospects in clinical research. Gain the knowledge and skills required to excel in roles related to clinical trial management, monitoring, and regulatory affairs.Global Opportunities: ICH-GCP is an internationally recognized standard. Equip yourself with skills that are in demand worldwide, opening doors to global career opportunities.Who Should Enroll:Clinical Research Associates (CRAs)Clinical Trial CoordinatorsInvestigatorsRegulatory Affairs ProfessionalsAnyone interested in Ethical clinical researchDon't miss this opportunity to gain a comprehensive understanding of "Good Clinical Practice" and enhance your career in clinical research. Enroll now and take the first step toward becoming a proficient clinical research professional!Note: No prior knowledge of clinical research is required. Basic understanding of medical terminology is recommended.
