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
eLearningThis 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.
eLearningExamine 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
eLearningExplore 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)
eLearningLearn 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
eLearningTake a guided overview of the FDA–Title 21 and HHS–Title 45 regulations that govern research studies.