Clinical Trials Operations Specialization

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

PRICE

$ 100 /Course

Overview

What you'll learn

  • Design and implement clinical trials

  • Collect, manage, and analyze data

  • Conduct trial monitoring and quality assurance

  • Recruit and retain clinical trial particpants

About this Specialization

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.

There are 4 Courses in this Specialization

01  Design and Conduct of Clinical Trials

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.

02  Clinical trials data management & quality assurance

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.

03  Clinical data management & advanced operations

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.

04  Clinical trials analysis, monitoring, and presentation

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.

Who this course is for?

  • Graduate or postgraduate degree in Pharmacy or Pharmaceutical Sciences
  • Graduate or postgraduate degree in Medicine
  • Graduate or postgraduate degree in Chemistry (subject) with securing at least 50% marks in aggregate

Course content

1 section • 16 lectures • 6h 34m total length

Instructor

Janet Masterson

Financial Analyst

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