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Overview
This series of activities explores the processes, research trials, and other considerations for developing and delivering a new drug product to the market.
Part I: Clinical Research
Lesson 1: Drug Development Overview
eLearning
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 explores the phases of clinical trials including the test candidates, testing outcomes, and timelines associated with each phase.
Lesson 2: Human Subjects Protection and Informed Consent
eLearning
Examine the reasons why there are protections for human participants in research studies and how permissions are collected from the candidates. Then use what you’ve learned to evaluate patient profiles for inclusion or exclusion in a possible trial.
Lesson 3: Regulations and Guidance
eLearning
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.Part II: Clinical Trials
Lesson 1: Institutional Review Board (IRB)
eLearning
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 waivers for clinical research studies.
Lesson 2: Comparing Title 45 and Title 21
eLearning
Take a guided overview of the FDA–Title 21 and HHS–Title 45 regulations that govern research studies.
Lesson 3: Clinical Research Study Management
eLearning
See how clinical trials of a research drug or medical device are conducted and managed.