Fundamentals of Good Clinical Practice: Prep and Personnel
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Fundamentals of Good Clinical Practice: Prep and Personnel
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 details of good clinical practice, and regulatory requirements.
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There are 3 modules in this course
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.
What's included
3 videos1 reading1 assignment
3 videos•Total 8 minutes
- Introduction to the course•2 minutes
- Preparing for a Site Selection Visit•1 minute
- About Site Selection Visits•5 minutes
1 reading•Total 3 minutes
- Re-introduction to our characters•3 minutes
1 assignment•Total 10 minutes
- Week One Graded Assessment•10 minutes
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+.
What's included
9 videos2 readings2 assignments
9 videos•Total 23 minutes
- Essential Documents for the IRB/IEC•3 minutes
- What are Essential Documents?•3 minutes
- Introducing the IRB/IEC•3 minutes
- Working with the IRB/IEC•1 minute
- IRB/IEC Submission and Approval•6 minutes
- Source Data & ALCOA+•4 minutes
- Case Report Forms (CRF)•2 minutes
- Electronic Medical Records•2 minutes
- Assessment of Electronic Medical Records•1 minute
2 readings•Total 20 minutes
- List of Essential Documents•10 minutes
- Requirements for Electronic Medical Records•10 minutes
2 assignments•Total 25 minutes
- Week Two Graded Assessment•20 minutes
- Test Your Knowledge - Essential Documents•5 minutes
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.
What's included
5 videos2 readings3 assignments
5 videos•Total 19 minutes
- Responsibilities of an Investigator•6 minutes
- Becoming an Investigator•5 minutes
- Form FDA 1572•2 minutes
- Maintaining Oversight of Trials•4 minutes
- Onboarding and Training Site Staff•3 minutes
2 readings•Total 20 minutes
- Financial Disclosures•10 minutes
- Site Staff and Delegation of Duties•10 minutes
3 assignments•Total 30 minutes
- Week Three Graded Assessment•20 minutes
- Test Your Knowledge - Investigator's Responsibilities•5 minutes
- Test Your Knowledge - Site Staff•5 minutes
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Reviewed on Feb 24, 2024
This course helped me a lot to have a better understanding of good clinical practice.
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 Jul 29, 2024
Amazing course with great examples throughout the course. Thanks for the training but it did not receive certificate even after completion.
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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Financial aid available,