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Janet Holbrook, PhD, MPH, Elizabeth A. Sugar, PhD, David M. Shade, JD, Ann-Margret Ervin, PhD, MPH, Anne Shanklin Casper, MA, Sheriza Baksh, PhD, and Stephan Ehrhardt, MD, MPH

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.

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What's inside

Four courses

Design and Conduct of Clinical Trials

(0 hours)
In this course, you'll learn how to design and conduct clinical trials. You'll learn to control for bias, randomize participants, mask treatments and outcomes, identify errors, develop and test hypotheses, and define appropriate outcomes. Finally, you'll learn the guiding principles and develop the essential skills to ethically and conscientiously recruit, obtain consent from, and retain trial participants.

Clinical Trials Data Management and Quality Assurance

(0 hours)
In this course, you'll learn to collect, care for, and protect the data gathered during your trial. You'll also learn how to find and correct deficiencies through performance monitoring, manage treatment interventions, and implement quality assurance protocols.

Clinical Trials Management and Advanced Operations

(0 hours)
In this course, you’ll explore advanced clinical trials management techniques. You’ll learn to anticipate and plan for protocol events, conduct systematic reviews, and synthesize evidence. You’ll also gain skills in recognizing and responding to problems and adverse events, complying with regulations, and promoting transparency. Finally, you’ll discover how standardized study documents can enhance your research.

Clinical Trials Analysis, Monitoring, and Presentation

(0 hours)
In this course, you will learn advanced operational skills for running clinical trials, including sample size calculation, statistical monitoring, and reporting results. You will also explore the role of the analyst and additional topics like simulations and adaptive designs.

Learning objectives

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

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