Introduction to Clinical Research: Part 5 – Comparing Title 45 and Title 21

Comparing Title 45 and Title 21


Take a guided overview of the FDA–Title 21 and HHS–Title 45 regulations that govern research studies.

Learning Objectives

  1. Discuss the role of the FDA and the HHS in research studies
  2. Explain the importance of regulations and compliance for research studies
  3. Describe the differences between FDA Title 21 and HHS Title 45 
  4. Determine whether Title 21, Title 45, or both apply to several example scenarios
Examine the reasons why there are protections for human participants in research studies and how... more
Explore the federal and international regulations that protect human participants in research... more
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See how clinical trials of a research drug or medical device are conducted and managed.