Introduction to Good Clinical Practice
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Introduction to Good Clinical Practice
This course is part of Clinical Trials: Good Clinical Practice Specialization
Instructor: Novartis Learning
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What you'll learn
Explore the clinical trial process, the basics of good clinical practice, and the history of regulatory frameworks for medical treatment and testing.
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There are 3 modules in this course
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!
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.
What's included
7 videos1 reading3 assignments
7 videos•Total 21 minutes
- Introduction to Good Clinical Practice•2 minutes
- What's a clinical trial?•2 minutes
- What are the phases of clinical trials?•2 minutes
- Why participate in a clinical trial?•1 minute
- A sponsor's view of clinical trials•3 minutes
- Drug research and development•7 minutes
- Who conducts clinical trials and why?•3 minutes
1 reading•Total 3 minutes
- Introduction to our characters•3 minutes
3 assignments•Total 40 minutes
- Module One Graded Assessment•30 minutes
- Challenge•5 minutes
- Challenge•5 minutes
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.
What's included
6 videos4 assignments
6 videos•Total 15 minutes
- Definitions of words used in clinical trials•2 minutes
- Medical care vs clinical research•1 minute
- What are the risks and benefits of clinical trials?•2 minutes
- The history of Good Clinical Practice and why it matters•5 minutes
- What is informed consent?•3 minutes
- Data integrity principles overview•1 minute
4 assignments•Total 48 minutes
- Module 2 Graded Assessment•30 minutes
- Challenge•5 minutes
- Challenge•8 minutes
- Challenge•5 minutes
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.
What's included
7 videos3 assignments
7 videos•Total 20 minutes
- How does clinical trial research make a difference?•2 minutes
- What's it like to be part of a clinical trial•2 minutes
- What is the process for Dr. Novel taking part in a clinical trial?•3 minutes
- How do patients get involved in clinical trials?•1 minute
- Diversity in clinical trials•7 minutes
- Why patients might be excluded from clinical trials•2 minutes
- A patient's story•2 minutes
3 assignments•Total 40 minutes
- Module 3 Graded Assessment•30 minutes
- Challenge•5 minutes
- Challenge•5 minutes
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Reviewed on May 3, 2025
Very informative and well-organized train of thoughts
Reviewed on Jul 22, 2023
Interesting and captivating animations. Real life interviews made this course so real and engrossing. Thank you.
Reviewed on Jun 15, 2026
Outstanding I learned a lot of news things in this course
Frequently asked questions
To access the course materials, assignments and to earn a Certificate, you will need to purchase the Certificate experience when you enroll in a course. You can try a Free Trial instead, or apply for Financial Aid. The course may offer 'Full Course, No Certificate' instead. This option lets you see all course materials, submit required assessments, and get a final grade. This also means that you will not be able to purchase a Certificate experience.
When you enroll in the course, you get access to all of the courses in the Specialization, and you earn a certificate when you complete the work. Your electronic Certificate will be added to your Accomplishments page - from there, you can print your Certificate or add it to your LinkedIn profile.
Yes. In select learning programs, you can apply for financial aid or a scholarship if you can’t afford the enrollment fee. If fin aid or scholarship is available for your learning program selection, you’ll find a link to apply on the description page.
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