Material Detail

"Fundamentals of Clinical Trials" icon

Fundamentals of Clinical Trials

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... Show More
Rate

Quality

  • Editor Reviews
  • User Rating
  • Comments
  • Learning Exercises
  • Bookmark Collection (1) Bookmark Collections
  • Course ePortfolios
  • Accessibility Info

More about this material

Comments

Log in to participate in the discussions or sign up if you are not already a MERLOT member.