Clinical Research for Medical Devices
4.6 (7 ratings)
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31 students enrolled
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Clinical Research for Medical Devices

Comprehensive instruction on the guidelines and methods of clinical research.
4.6 (7 ratings)
Instead of using a simple lifetime average, Udemy calculates a course's star rating by considering a number of different factors such as the number of ratings, the age of ratings, and the likelihood of fraudulent ratings.
31 students enrolled
Created by Dr. Josh Simon
Last updated 11/2016
English
Price: $90
30-Day Money-Back Guarantee
Includes:
  • 1 hour on-demand video
  • 1 Article
  • 1 Supplemental Resource
  • Full lifetime access
  • Access on mobile and TV
  • Certificate of Completion
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What Will I 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
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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 is the target audience?
  • 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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Curriculum For This Course
Expand All 8 Lectures Collapse All 8 Lectures 01:52:19
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Clinical Research for Medical Devices
8 Lectures 59:20

Information about who should take the course and instructor bio.

Preview 06:00

Discussion forum for the Clinical Research for Medical Devices course

Clinical Research Discussion Forum
00:03

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

Preview 08:57

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

Informed Consent and Institutional Review Boards
13:47

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

Clinical Trial Roles and Responsibilities
17:59

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

Types of Clinical Trials
11:06

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

Clinical Research Certification Notes
01:28

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.

Clinical Research Certification Notes - eBook
53 pages
About the Instructor
Dr. Josh Simon
4.6 Average rating
139 Reviews
3,078 Students
6 Courses
Medical Device Development Professional

Currently, I am Principal Consultant at Spiral Medical Development and an Adjunct Professor at the New Jersey Institute of Technology. For over 10 years, I have worked in various roles developing medical devices and have touched perhaps hundreds of them in varying capacities from concept to launch.

As someone that loves to give back and feels obligated to teach those that are coming after me in the medical device industry, I have always said that it is important to excel in at least two things. Every day I try to be an example to my coworkers and students by using my experience in research and business to bridge the gap between the two. This usually involves conversations from all perspectives covering project management, medical device product development, marketing, training, and research planning. Being able to explain tough concepts to audiences without background in a subject has been my forte, and I have used it in numerous device companies, sales training classes, CME, and Grand Rounds presentations around the world. Going the other way, I have conveyed crucial business strategies to motivate product development and research professionals both in industry and academia. While my formal training is in general business and Biomedical Engineering with specific interest in bone tissue engineering and biomaterials, I see myself as a translator. The languages of business and science are not often mutually understood, and I act as the intermediary.