Introduction to Good Clinical Practice

Ends in 3 days! Save 40% on your access to 10,000+ programs and make a real impact in your career. Save now.

Introduction to Good Clinical Practice

This course is part of Clinical Trials: Good Clinical Practice Specialization

Instructor: Novartis Learning

33,790 already enrolled

Included with Learn more

Ask Coursera

3 modules

Gain insight into a topic and learn the fundamentals.

Beginner level

Recommended experience

3 hours to complete

Flexible schedule

Learn at your own pace

3 modules

Gain insight into a topic and learn the fundamentals.

Beginner level

Recommended experience

3 hours to complete

Flexible schedule

Learn at your own pace

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.

Skills you'll gain

Details to know

Shareable certificate

Add to your LinkedIn profile

Assessments

10 assignments

Taught in English

See how employees at top companies are mastering in-demand skills

Learn more about Coursera for Business

logos of Petrobras, TATA, Danone, Capgemini, P&G and L'Oreal

Build your subject-matter expertise

This course is part of the Clinical Trials: Good Clinical Practice Specialization

When you enroll in this course, you'll also be enrolled in this Specialization.

Learn new concepts from industry experts
Gain a foundational understanding of a subject or tool
Develop job-relevant skills with hands-on projects
Earn a shareable career certificate

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 videosTotal 21 minutes

Introduction to Good Clinical Practice2 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 trials3 minutes
Drug research and development7 minutes
Who conducts clinical trials and why?3 minutes

1 readingTotal 3 minutes

Introduction to our characters3 minutes

3 assignmentsTotal 40 minutes

Module One Graded Assessment30 minutes
Challenge5 minutes
Challenge5 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 videosTotal 15 minutes

Definitions of words used in clinical trials2 minutes
Medical care vs clinical research1 minute
What are the risks and benefits of clinical trials?2 minutes
The history of Good Clinical Practice and why it matters5 minutes
What is informed consent?3 minutes
Data integrity principles overview1 minute

4 assignmentsTotal 48 minutes

Module 2 Graded Assessment30 minutes
Challenge5 minutes
Challenge8 minutes
Challenge5 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 videosTotal 20 minutes

How does clinical trial research make a difference?2 minutes
What's it like to be part of a clinical trial2 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 trials7 minutes
Why patients might be excluded from clinical trials2 minutes
A patient's story2 minutes

3 assignmentsTotal 40 minutes

Module 3 Graded Assessment30 minutes
Challenge5 minutes
Challenge5 minutes

Earn a career certificate

Add this credential to your LinkedIn profile, resume, or CV. Share it on social media and in your performance review.

Instructor

Novartis Learning

Novartis

4 Courses36,270 learners

Offered by

Novartis

Explore more from Research

Novartis
Fundamentals of Good Clinical Practice: Prep and Personnel
Course
Status: Free Trial
Novartis
Clinical Trials: Good Clinical Practice
Specialization
Status: Free Trial
Novartis
Fundamentals of Good Clinical Practice: Recruitment & Trial
Course
Status: Free Trial
EDUCBA
Drug Development and Clinical Research
Course
Category: Preview

Why people choose Coursera for their career

Felipe M.

Learner since 2018

"To be able to take courses at my own pace and rhythm has been an amazing experience. I can learn whenever it fits my schedule and mood."

Jennifer J.

Learner since 2020

"I directly applied the concepts and skills I learned from my courses to an exciting new project at work."

Larry W.

Learner since 2021

"When I need courses on topics that my university doesn't offer, Coursera is one of the best places to go."

Chaitanya A.

"Learning isn't just about being better at your job: it's so much more than that. Coursera allows me to learn without limits."

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.