Clinical Research for Medical Devices

Clinical Research For Medical Devices


This course takes the painfully dry regulations and methods used for clinical trials on medical devices and distills them nicely into a clean overview over the course of an hour. Students will learn about Good Clinical Practices (GCP’s) and the regulations that govern clinical trials in the USA and rest of world, such as 21 CFR Parts 50, 56, and 812 and the ICH guidelines. As a “quick hit” to gain knowledge, this course works wonderfully for getting new trainees to hit the ground running. It also serves to increase knowledge for those currently working as Clinical Research Associates (CRA’s), especially those who are soon looking to take a certification exam for clinical research, such as SOCRA. Whether seeking to brush up on prior knowledge or getting started as a new trainees, this course is beneficial to Clinical Research professionals along the entire continuum.

Clinical Research Course Objectives:

  • Understand the process for designing and running clinical trials on medical devices
  • Understand the rights of patients and the responsibilities of sponsors and investigators
  • Combine this knowledge with personal experience to pass the various clinical research certification exams
  • Become familiar with Good Clinical Practices (GCP’s)
  • Understand and summarize clinical research regulations such as the ICH guidelines and 21 CFR parts 50, 56, and 812

Who should take this course?

  • Clinical Research Associates looking to expand their knowledge
  • Individuals preparing to test for a clinical research certification
  • Experienced clinical professionals looking to brush up on regulations
  • Medical Device Project Managers that need to understand the role of clinical research on their team

What you get:

  • Unlimited time access to 6 recorded online lectures (~ 1 hr of content)
  • A 50-page e-book of bullet point notes on regulations covered on many clinical research certification exams (21CFR 50, 56, 312, 812,  ICH Guidelines, and more)
  • Access to a medical device forum for discussing/asking questions to the instructor
  • Free updates to course material

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