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

Comprehensive instruction on the guidelines and methods of clinical research.

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What you will 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

Rating: 4.1

Level: Intermediate Level

Duration: 2 hours

Instructor: Josh Simon