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Clinical Research for Medical Devices
Rating: 4.3 out of 5(32 ratings)
98 students

Clinical Research for Medical Devices

Comprehensive instruction on the guidelines and methods of clinical research.
Created byJosh Simon
Last updated 11/2016
English

What you'll learn

  • 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

Course content

1 section • 8 lectures • 59m total length

  • Introduction to Clinical Research6:00

    Information about who should take the course and instructor bio.

  • Clinical Research Discussion Forum0:02

    Discussion forum for the Clinical Research for Medical Devices course

  • Origins of Human Research Studies8:57

    A brief history of how the current guidelines and regulations for Clinical Research came into being.

  • Informed Consent and Institutional Review Boards13:47

    Students will gain a summarized overview of 21 CFR parts 50 and 56 for rules regarding patient informed consent and IRB's.

  • Clinical Trial Roles and Responsibilities17:59

    Understand the roles played by the Sponsor, Investigator, and Monitors.

  • Types of Clinical Trials11:06

    Overview of the different types of clinical trials and various parameters defined for each.

  • Clinical Research Certification Notes1:28

    Explanation of the attached notes to study for Clinical Research certifications.

  • Clinical Research Certification Notes - eBook53:00

    A 50-page e-book that summarizes in bullet point form all of the regulations needed for conduction of clinical research, and those that are most asked about on clinical research certification exams.

Requirements

  • Students will need a general understanding of what clinical trials and clinical research are

Description

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 the knowledge of current Clinical Research Associates, especially those who are soon looking to take a certification exam for clinical research.

Who this course is for:

  • 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

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