This series of activities explores the processes, research trials, and other considerations for developing and delivering a new drug product to the market.
Lesson 1: Drug Development Overview
This course provides a general overview of the process used to develop drugs and why it costs so much to bring those drugs to market. It also…
Lesson 2: Human Subjects Protection and Informed Consent
Examine the reasons why there are protections for human participants in research studies and how permissions are collected from the candidates. Then…
Lesson 3: Regulations and Guidance
Explore the federal and international regulations that protect human participants in research studies. Then use what you’ve learned to conduct…
Lesson 1: Institutional Review Board (IRB)
Learn more about the Belmont Report as the foundation for the Institutional Review Board, an overview of the levels of review, and the use of consent…
Lesson 2: Comparing Title 45 and Title 21
Take a guided overview of the FDA–Title 21 and HHS–Title 45 regulations that govern research studies.
Lesson 3: Clinical Research Study Management
See how clinical trials of a research drug or medical device are conducted and managed.