• Overview of GCP Training

    GCP 课程综述

    The principles of Good Clinical Practice (GCP) underpin the legal requirements for the conduct of clinical trials around the world. Originally developed as a unified standard by the European Union (EU), Japan and the United States (US), it also forms the basis of national regulation in many other countries, including China, India, Korea and Brazil.

    A strong understanding of GCP is a fundamental requirement for anyone intending to develop a career in any aspect of clinical research, whether in industry, healthcare provision or academia.

    This course introduces GCP for new professionals, but also serves as a refresher for those who feel they need it. The programme is clear and simple in design and gives full instructions for use.

    临床试验药物管理规范的准则是为世界各地的临床试验行为提供法律依据。最初它是欧盟,日本和美国开发的统一标准,同时也成为了其它国家,包括中国,印度,韩国和巴西等国家的基础模式。

    深入理解GCP,是开发临床试验研究生涯中的基本要求,无论是在工业,医疗保健,或者学术研究方面。

    本课程为新进的专业人士提供GCP的介绍,同时也适用于那些需要再次进修的人们。此程序设计清楚简单,并提供了充分的使用说明。

    Screenshot GCP

    Benefits of using this module

    Screenshot GCP Chinese

    课程特色

    • Understand the global standard, and key variations in specific countries (eg, China)
    • Learn when and where you want, with the flexibility of online learning
    • Learn more effectively with video lecture capture
    • Choose between lectures delivered in English or Chinese
    • The topics cover ICH and SFDA standards
    • Integrate with corporate learning management systems via SCORM compliance

    Request a demo account or view a sample

    • 了解全球标准,以及在特定国家的重点差异(如中国)
    • 随时随刻可以灵活在网上了解你想要得到的信息
    • 使用更有效的视频教学
    • 选择中英对照的讲座
    • 内容涵盖 ICH 和 SFDA
    • 得到“混合教学“,导师在线支持
    • 融合了企业学习管理系统,SCORM
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本课程深入讲解 GCP 原则。阐述 GCP 的目的与意义,指导原则的关键特征,相关职责以及对于必需文件的要求。

学习目的

在完成本课程之后,你将可以 ……

  • 阐述 GCP 的历史,目的和意义
  • 探讨临床研究人员和伦理委员会的职责
  • 阐述对于必需文件的要求
  • 探讨 GCP 在临床试验中的实际应用

完成本课程将获得 ICR CPD 的 10 个积分点

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This module provides an insight into the principles of GCP. It describes the purpose of GCP, looks at the key features of the guideline, the roles and responsibilities involved and the requirements of essential documentation.

Learning objectives

By the end of this course, you will be able to…

  • Describe the history and purpose of GCP
  • Discuss the roles and responsibilities of clinical trial staff and ethics committees according to ICH GCP
  • Describe the requirements of essential documentation
  • Discuss the practical application of ICH GCP to the clinical trial process

Completing this module is worth 10 ICR CPD points

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