Regulations and Guidance

Lesson 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

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