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Coursera

Introduction to Good Clinical Practice

Novartis via Coursera

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Overview

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Welcome to 'Introduction to Good Clinical Practice'! This course is designed to introduce you to the basic principles and practices of Good Clinical Practice (GCP), which are essential for conducting clinical trials and ensuring the safety and well-being of human subjects. Whether you are new to the field or seeking to refresh your knowledge, this course and its sequel courses covering the fundamentals of Good Clinical Practice will equip you with the necessary skills and understanding to begin to navigate the complex world of clinical research. Developed by industry experts, the course offers an introduction to the key concepts, guidelines, and regulatory requirements outlined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) GCP guidelines. During this course, you will explore the essential elements of Good Clinical Practice and gain insights into its significance in the global clinical research arena. By the end of the course, you will have a solid understanding of the principles of GCP and its role in ensuring the integrity and reliability of clinical trial data. The course is divided into several modules, each covering specific aspects of GCP. The modules include video lectures and interactive quizzes to reinforce your learning. You can progress through the course at your own pace, allowing you to fit your studies around your existing commitments and responsibilities. We are excited to embark on this learning journey with you as we delve into the world of Good Clinical Practice. Enroll now and start building a strong foundation in clinical research ethics and regulations!

Syllabus

  • Module One Introduction
    • In Module One you’ll learn the basics of what a clinical trial is. You’ll hear from investigators, patients, and sponsors about the benefits of clinical trials, and you’ll learn about the drug discovery process.
  • Module Two Introduction
    • In Module Two we’ll focus on some important rules and regulations. You’ll find out why good clinical practice matters and learn about the history of regulatory frameworks for medical treatment and testing. We’ll also explore some clinical trial definitions, look at informed consent, talk about risk, and discuss data integrity.
  • Module Three Introduction
    • In Module Three we’ll explore how research in clinical trials makes a difference. We’ll also walk you through what medical teams and patients must do to become involved. You’ll learn about the importance of diversity in clinical trials, inclusion and exclusion criteria, and we’ll hear from some patients who’ll tell us how they experienced the trial process.

Taught by

Novartis Learning

Reviews

4.7 rating at Coursera based on 97 ratings

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