Lesson 2: Comparing Title 45 and Title 21

Elements of Good Documentation Practices (GDP) and Data Integrity
Overview
Take a guided overview of the FDA–Title 21 and HHS–Title 45 regulations that govern research studies.
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
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