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This course is part of Clinical Trials: Good Clinical Practice Specialization
Instructor: Novartis Learning
5,447 already enrolled
Included with
(93 reviews)
Recommended experience
Beginner level
We recommend taking Introduction to Good Clinical Practice before taking this course.
(93 reviews)
Recommended experience
Beginner level
We recommend taking Introduction to Good Clinical Practice before taking this course.
Explore the clinical trial process, the details of good clinical practice, and regulatory requirements.
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Welcome to 'Fundamentals of Good Clinical Practice: Prep and Personnel'! This course is designed to introduce you to preparing for a clinical trial.
This is Course Two in the Clinical Trial Teams series - the first course 'Introduction to Good Clinical Practice' provides background on what clinical trials are as well as the basic principles and practices of GCP. If you are new to the world of clinical research, we suggest starting your journey with Course One. In Course Two, we turn our attention to the conduct of clinical trials, exploring in detail the role of the Investigator and site staff throughout a study. Whether you are new to the field or seeking to refresh your knowledge, this course will equip you with the necessary understanding to begin to navigate the complex world of clinical research. The course is divided into several modules, each covering specific stages of a clinical trial. The modules include a variety of videos, a fictional case study and interactive quizzes to reinforce your learning. 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 the conduct of clinical research!
In Week One, you'll learn about the preparations and qualification criteria required for an Investigator and their site to participate in a Clinical Trial, and learn about Site Selection Visits.
3 videos1 reading1 assignment
In Week Two, you'll continue to learn about the preparations and qualification criteria required for an Investigator and their site to participate in a Clinical Trial. Topics include essential documents, the role of the Institutional Review Board / Independent Ethics Committee (IRB / IEC), and source data and ALCOA+.
9 videos2 readings2 assignments
In Week Three, you'll learn about the role and responsibilities of a Primary Investigator, including practical advice and guidance on how to succeed in the role. You'll also learn about how site staff support a clinical trial.
5 videos2 readings3 assignments
We asked all learners to give feedback on our instructors based on the quality of their teaching style.
Johns Hopkins University
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Johns Hopkins University
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Johns Hopkins University
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93 reviews
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Reviewed on May 15, 2024
This course was not only informative, but also provided questions throughout videos to ensure the retaining of correct information.
Reviewed on Feb 24, 2024
This course helped me a lot to have a better understanding of good clinical practice.
Reviewed on Feb 3, 2024
This course helped me further understand clinical trials and what is required of the primary investigator and site.
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Access to lectures and assignments depends on your type of enrollment. If you take a course in audit mode, you will be able to see most course materials for free. To access graded assignments and to earn a Certificate, you will need to purchase the Certificate experience, during or after your audit. If you don't see the audit option:
The course may not offer an audit option. 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. If you only want to read and view the course content, you can audit the course for free.
If you subscribed, you get a 7-day free trial during which you can cancel at no penalty. After that, we don’t give refunds, but you can cancel your subscription at any time. See our full refund policy.
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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