In this course, you’ll learn how to design and carry out clinical trials. Each design choice has implications for the quality and validity of your results. This course provides you and your team with essential skills to evaluate options, make good design choices, and implement them within your trial. You’ll learn to control for bias, randomize participants, mask treatments and outcomes, identify errors, develop and test hypotheses, and define appropriate outcomes. Finally, a trial without participants is no trial at all, so you’ll learn the guiding principles and develop the essential skills to ethically and conscientiously recruit, obtain consent from, and retain trial participants.
Design and Conduct of Clinical Trials
This course is part of Clinical Trials Operations Specialization
Instructors: Janet Holbrook, PhD, MPH
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(260 reviews)
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What you'll learn
Evaluate and select clinical trial designs
Implement bias control measures
Randomize participants into groups
Define clinical trial outcomes
Skills you'll gain
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There are 5 modules in this course
Every trial design depends on the skilled application of core design elements. In this module, you’ll learn about various approaches to bias control as well as simple, restricted, and adaptive approaches to trial participant randomization. Finally, you’ll learn to protect the validity of your results with masking procedures that conceal treatments and outcomes as necessary from the study team, participants, and outcomes assessors.
What's included
7 videos1 reading1 assignment
Each trial is conducted in stages, so it’s critical that you and your team are prepared to make sound design choices for each stage. That includes developing and evaluating research questions and hypotheses, selecting among various design types, and identifying errors.
What's included
8 videos1 assignment
Well-defined outcomes are the foundation of any good trial design. The outcomes that you and your team establish at the beginning of the design process will influence other design decisions such as trial type, randomization, masking, sample size, and more.
What's included
4 videos1 assignment
Trials participants must be treated with the utmost respect, and that begins with careful attention to informed consent. In this module, you’ll learn about the personnel, documents, terminology, and practices that go into planning and implementing ethically sound informed consent procedures within your trial.
What's included
3 videos1 assignment
A trial without participants is no trial at all. In this module, you’ll learn how to ethically and effectively recruit and retain the participants you need for your trial and strategically select the clinical sites where you’ll conduct your research.
What's included
5 videos1 reading1 assignment
Instructors
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Recommended if you're interested in Public Health
Johns Hopkins University
University of Michigan
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Reviewed on Feb 1, 2023
Great overview of the key aspects of Clinical Trial design and conduct, a great introduction to the topic at the right level of detail.
Reviewed on May 9, 2024
The lecturers deliver on point content and it's always easy to access the information anytime anywhere. Thank you.
Reviewed on Nov 9, 2023
Very easy-to-understand content. Highly practical and relevant information.
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Frequently asked questions
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:
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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.