Design and Conduct Successful Clinical Trials. Build skills for conducting successful and impactful clinical trials.

4.7

stars

60 ratings

Janet Holbrook, PhD, MPH +6 more instructors

2,621 already enrolled

Offered By

Clinical Trials Operations SpecializationJohns Hopkins University

What you will learn

Design and implement clinical trials
Collect, manage, and analyze data
Conduct trial monitoring and quality assurance
Recruit and retain clinical trial particpants

Skills you will gain

About this Specialization

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This specialization is designed for individuals and teams that will be running or interacting with clinical trials. In four courses, learners will develop insights and build the skills they need to design, manage, and monitor clinical trials as well as analyze, document, and communicate the results. Learners will also learn best practices regarding ethics, safety, participant recruitment, regulatory compliance, and reporting standards. The core principles and skills of the specialization will lay the foundation for a successful career in the field.

Applied Learning Project

Learners will demonstrate their mastery of skills, including trial design, data collection and management, statistical monitoring, trial ethics, participant recruitment and retention, data analysis, communication of results, and advanced operational techniques.

Shareable Certificate

Earn a Certificate upon completion

100% online courses

Start instantly and learn at your own schedule.

Coursera Labs

Includes hands on learning projects.

Learn more about Coursera Labs

Flexible Schedule

Set and maintain flexible deadlines.

Beginner Level

Approximately 4 months to complete

Suggested pace of 3 hours/week

English

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Shareable Certificate

Earn a Certificate upon completion

100% online courses

Start instantly and learn at your own schedule.

Coursera Labs

Includes hands on learning projects.

Learn more about Coursera Labs

Flexible Schedule

Set and maintain flexible deadlines.

Beginner Level

Approximately 4 months to complete

Suggested pace of 3 hours/week

English

Could your company benefit from training employees on in-demand skills?

Try Coursera for Business

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

Learn more about Coursera for Business

How the Specialization Works

Take Courses

A Coursera Specialization is a series of courses that helps you master a skill. To begin, enroll in the Specialization directly, or review its courses and choose the one you'd like to start with. When you subscribe to a course that is part of a Specialization, you’re automatically subscribed to the full Specialization. It’s okay to complete just one course — you can pause your learning or end your subscription at any time. Visit your learner dashboard to track your course enrollments and your progress.

Hands-on Project

Every Specialization includes a hands-on project. You'll need to successfully finish the project(s) to complete the Specialization and earn your certificate. If the Specialization includes a separate course for the hands-on project, you'll need to finish each of the other courses before you can start it.

Earn a Certificate

When you finish every course and complete the hands-on project, you'll earn a Certificate that you can share with prospective employers and your professional network.

There are 4 Courses in this Specialization

Course1

Course 1

Design and Conduct of Clinical Trials

4.7

stars

42 ratings

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.

Course2

Course 2

Clinical Trials Data Management and Quality Assurance

4.8

stars

18 ratings

In this course, you’ll learn to collect and care for the data gathered during your trial and how to prevent mistakes and errors through quality assurance practices. Clinical trials generate an enormous amount of data, so you and your team must plan carefully by choosing the right collection instruments, systems, and measures to protect the integrity of your trial data. You’ll learn how to assemble, clean, and de-identify your datasets. Finally, you’ll learn to find and correct deficiencies through performance monitoring, manage treatment interventions, and implement quality assurance protocols.

Course3

Course 3

Clinical Trials Management and Advanced Operations

4.7

stars

15 ratings

In this course, you’ll learn about the more advanced elements of managing clinical trials. From anticipating and planning for protocol events to conducting systematic reviews to synthesize evidence, you and your study team need the skills to implement best practices throughout the trial process. You’ll learn how to recognize and respond to problems and adverse events, comply with regulations, and participate in frameworks that promote transparency. You’ll also learn how systematic review and meta-analysis is used to synthesize evidence from multiple sources. Finally, you’ll learn how your research can benefit from the adoption and consistent use of standardized study documents.

Course4

Course 4

Clinical Trials Analysis, Monitoring, and Presentation

4.7

stars

10 ratings

In this course, you’ll learn more advanced operational skills that you and your team need to run a successful clinical trial. You’ll learn about the computation of sample size and how to develop a sample size calculation that’s suitable for your trial design and outcome measures. You’ll also learn to use statistical methods to monitor your trial for safety, integrity, and efficacy. Next, you’ll learn how to report the results from your clinical trials through both journal articles and data monitoring reports. Finally, we’ll discuss the role of the analyst throughout the trial process, plus a few additional topics such as simulations and adaptive designs.

Instructors

Offered by

Johns Hopkins University

Frequently Asked Questions

What is the refund policy?
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.
Can I just enroll in a single course?
Yes! To get started, click the course card that interests you and enroll. You can enroll and complete the course to earn a shareable certificate, or you can audit it to view the course materials for free. When you subscribe to a course that is part of a Specialization, you’re automatically subscribed to the full Specialization. Visit your learner dashboard to track your progress.
Is financial aid available?
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.
Can I take the course for free?
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. If you only want to read and view the course content, you can audit the course for free. If you cannot afford the fee, you can apply for financial aid.
Is this course really 100% online? Do I need to attend any classes in person?
This course is completely online, so there’s no need to show up to a classroom in person. You can access your lectures, readings and assignments anytime and anywhere via the web or your mobile device.
How long does it take to complete the Specialization?
It typically takes about four months to complete this specialization, but learners are free to work at their own pace.
What background knowledge is necessary?
We recommend that learners have some familiarity with basic scientific, statistical, and management concepts.
Do I need to take the courses in a specific order?
The sequence provided is optimal, but not required.
Will I earn university credit for completing the Specialization?
No, Johns Hopkins University does not award academic credit for its courses and specializations on Coursera.

More questions? Visit the Learner Help Center.

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Clinical Trials Operations Specialization

What you will learn

Skills you will gain

About this Specialization

Applied Learning Project