- Level Foundation
- Duration 3 hours
- Course by Novartis
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Offered by
About
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 coming sequel, '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!Modules
Introduction to Good Clinical Practice
1
Videos
- Introduction to Good Clinical Practice
1
Readings
- Introduction to our characters
What's a clinical trial?
1
Assignment
- Challenge
1
Videos
- What's a clinical trial?
What are the phases of clinical trials?
1
Videos
- What are the phases of clinical trials?
Why participate in a clinical trial?
1
Videos
- Why participate in a clinical trial?
A sponsor's view of clinical trials
1
Assignment
- Challenge
1
Videos
- A sponsor's view of clinical trials
Drug research and development
1
Videos
- Drug research and development
Who conducts clinical trials and why?
1
Videos
- Who conducts clinical trials and why?
Graded Assessments
1
Assignment
- Module One Graded Assessment
Definitions of words used in clinical trials
1
Assignment
- Challenge
1
Videos
- Definitions of words used in clinical trials
Medical care vs clinical research
1
Videos
- Medical care vs clinical research
What are the risks and benefits of clinical trials?
1
Assignment
- Challenge
1
Videos
- What are the risks and benefits of clinical trials?
Why Good Clinical Practice matters
1
Assignment
- Challenge
1
Videos
- The history of Good Clinical Practice and why it matters
What is informed consent?
1
Videos
- What is informed consent?
Data integrity principles overview
1
Videos
- Data integrity principles overview
Graded Assignments
1
Assignment
- Module 2 Graded Assessment
How does clinical trial research make a difference?
1
Videos
- How does clinical trial research make a difference?
What's it like to be part of a clinical trial
1
Videos
- What's it like to be part of a clinical trial
What is the process for Dr. Novel taking part in a clinical trial?
1
Assignment
- Challenge
1
Videos
- What is the process for Dr. Novel taking part in a clinical trial?
How do patients get involved in clinical trials?
1
Videos
- How do patients get involved in clinical trials?
Diversity in clinical trials
1
Assignment
- Challenge
1
Videos
- Diversity in clinical trials
Why patients might be excluded from clinical trials
1
Videos
- Why patients might be excluded from clinical trials
A patient's story
1
Videos
- A patient's story
Graded Assessments
1
Assignment
- Module 3 Graded Assessment
Auto Summary
Embark on a transformative learning journey with the 'Introduction to Good Clinical Practice' course, designed to immerse you in the fundamental principles and practices of Good Clinical Practice (GCP). This foundational course is perfect for newcomers to the field of clinical research, as well as professionals seeking to refresh their knowledge and skills. Developed by industry leaders and offered by Coursera, this course provides comprehensive insights into the key concepts, guidelines, and regulatory requirements as outlined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Over a duration of 180 minutes, you will delve into the essential elements of GCP, understanding its critical role in safeguarding the safety and well-being of human subjects during clinical trials. The course is structured into several engaging modules, each featuring video lectures and interactive quizzes that allow for self-paced learning. This flexible approach enables you to balance your studies with other commitments seamlessly. Subscription options include the Starter and Professional plans, catering to different learning needs and professional development goals. With a focus on building a robust foundation in clinical research ethics and regulations, this course is ideal for science and engineering enthusiasts looking to make a significant impact in the field. Join us now and gain the expertise to navigate the complex landscape of clinical research with confidence and competence!

Novartis Learning