Fundamentals of Clinical Trials

UC Irvine (OCW)

Welcome to the course on Fundamentals of Clinical Trials developed by the University of California, Irvine OCW. Clinical trials are sets of tests in medical research to develop safety and efficacy information for health interventions, including drug development. Clinical trials are a critical part of overall public health research, and are only conducted after gaining approval from the US Food and Drug Administration upon presentation of nonclinical information on expected safety and efficacy. This course will provide an overview of the clinical trials process for the United States. Topics covered in this course include: * Planning processes underlying the Strategic Clinical Plan and regulatory submissions to the FDA; * Protocol development and implementation, such as study site selection, financial controls, timelines, and management of the site's operations; * Proper informed consent and privacy protection; * Good Clinical Practices compliance; * FDA regulations and guidelines; * Post-market support studies. You can study this course for free using the course materials and study group linked below. Review the materials, watch the videos, explore the topics and connect with your fellow students here on OpenStudy. The OpenStudy platform allows you to ask questions whenever you have them, and get answers from your peers and moderators. As you master the material, you will also answer questions from your peers. You may start studying and interacting anytime – start when you’re ready and end when you’ve met your learning goals. You may also earn a Certificate of Participation from the OpenCourseWare Consortium to recognize your efforts. This Certificate will document (i) your participation in the course, (ii) your progress through the course and (iii) three important skills that employers want to see documented: teamwork, engagement and problem solving skills. Whether you are a high school or college student or working adult looking to advance, this Certificate of Participation can help you get an edge. Getting started is easy: 1. Register for the Certificate below (Cost : $30). 2. Ask and answer questions on each topic in the course study group. You will receive a SmartScore based on these interactions 3. Engage for a minimum of 4 weeks on the OpenStudy study group for this course, and improve your SmartScore by a minimum of 20 points through your active participation in the study groups. You will be then be eligible for the certificate.

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