Introduction to Clinical Research: Part 3 – Regulations and Guidance

Regulations and Guidance


Explore the federal and international regulations that protect human participants in research studies. Then use what you’ve learned to conduct interviews and protocol reviews in audit scenarios.

Learning Objectives

  1. Describe potential regulation violations and their impact
  2. Conduct audit scenarios and Identify regulation violations based on the available data
  3. Explain how protocol violations impact clinical research trials 
  4. Conduct interviews and recognize protocol violations in several example scenarios
Examine the reasons why there are protections for human participants in research studies and how... more
Learn more about the Belmont Report as the foundation for the Institutional Review Board, an... more
Take a guided overview of the FDA–Title 21 and HHS–Title 45 regulations that govern research... more
See how clinical trials of a research drug or medical device are conducted and managed.