Course Description

US Safety Reporting Requirements during Pre-Market Clinical Trials

Course Description:

This course outlines the safety reporting requirements for significant and non-significant risk device clinical investigations in the US. The content adheres to the US FDA and US Institutional Review Boards. 

This course applies the requirements from CFR 812.150. 

Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Comply with US safety reporting regulations during clinical investigations for both significant and non-significant risk devices
  • Report any problems or deviations with the device that occur during clinical investigations
  • Set up the necessary quality system requirements to ensure compliance

Who Should Enroll:

Clinical research associates (monitors), senior clinical research associates, clinical project and compliance managers, clinical quality associates and managers, clinical affairs directors, clinical safety managers, and clinical and regulatory professionals from the pharmaceutical industry wanting to understand the regulatory differences in safety reporting during clinical investigations with medical devices are all welcome to enroll in this course.

Prerequisite Knowledge/Requirements:

The following courses are required:

  • Ethics Committee (EC)/Institutional Review Board Requirements (ID 46)
  • Adverse Event Processes (ID 59)

Subject Matter Expert:
Danielle Giroud
Greg Sachs

20 min

Related resources:

Case studies:

Basic Account: € 72.00
Premium Account: € 54.00

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