ISO 14155 2020 Safety and Adverse Events

$99.00

This lecture describes the key changes in the international ISO standard for clinical trials. In this module we will show you the main changes that have occurred compared to the ISO 14155 2011 in the safety and adverse event reporting.

  • Course Type: Video Lecture
  • Language: English
  • Level: Beginner
  • Session: year 2020
  • Time: 0 - 1 Hour

Course Breakdown

Section Time
Introduction 00:02:48
Definitions 00:02:30
Adverse Events and Device Deficiency 00:02:27
Responsibilities of the PI and Sponsor 00:04:52
Risks of under-reporting 00:00:33

Exam and Certifications

  • Final Test – ISO 14155 2020 Safety and Adverse Events
  • Certification

Description

What I will learn?

Safety and adverse events reporting.

Skills I will gain

This course will help you:
You will be able to clearly understand the new requirements and identify those already provided by ISO 14155:2011 and confirmed by the new version of the worldwide standard.

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