Clinical trials are designed to answer questions concerning the safety and effectiveness of medical products. Get an overview of clinical trials regulated by the FDA. Learn about the planning process underlying the Strategic Clinical Plan and regulatory submissions to the FDA. Explore topics including protocol development and implementation, i.e. study site selection, financial controls, timelines, and management of the site's operations; proper informed consent; Good Clinical Practices compliance; HIPAA; FDA regulations and guidelines; and post-market support studies.
UC Irvine’s OCW is a Web-based publication of the courses and course materials that support higher education. Educators are encouraged to use the materials for curriculum development, while students can augment their current learning by making use of the materials offered, and self-learners are encouraged to draw upon the material for self-study or supplementary use. Course materials offered on the UC Irvine Web site typically may be used, copied, distributed, translated and modified, but only for non-commercial educational purposes that are made freely available to other users. Each course shows its own license provisions, so please check carefully.
In the openly licensed format, UCI contributes to global education at no marginal cost to itself beyond the already completed filming. Our own students also benefit by being able to review presentations and because it is available on YouTube, we don’t have to worry about maintaining it on course pages behind password protection. By making it open, another institution or professor can use some or all of the video presentations without even having to contact us for permission. So we are fulfilling the mission of a land-grant, public university effectively and efficiently.