US Safety Reporting Requirements during Pre-Market Clinical Trials

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

The following courses are required:

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

General Requirements for WMDO Courses

• Course Access Duration: Each course is available for 60 days from the date of assignment.

• Quiz Completion: Users are allowed 2 attempts to complete each quiz, with a minimum passing score of 75%.