Introduction to Clinical Research: Part 3 – Regulations and Guidance

Regulations and Guidance

Overview

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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Introduction to Clinical Research: Part 4 – Institutional Review Board (IRB)

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

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Introduction to Clinical Research: Part 6 – Clinical Research Study Management

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See how clinical trials of a research drug or medical device are conducted and managed.