Clinical Trial Information System (CTIS)


In this course, you will learn all the important information about the CTIS, its timelines and user roles. You’ll also discover what training materials are available at European Medicines Agency website.

  • Course Type: Video Lessons
  • Language: English
  • Level: Advanced
  • Session: 2022
  • Time: 0 - 1 Hour

Course Breakdown

Section Time
Introduction 00:00:57
Clinical Trial Regulation 536/2014 00:03:42
The Keys Benefit of the CTR 536/2014 00:00:43
Clinical Trial Information System: What is it? 00:01:35
Timelines Implementation 00:01:07
CTIS Business Tool 00:00:39
CTIS Roles and Responsibilities 00:00:39
CTIS: Workspaces 00:03:11
Training Materials 00:08:32
CTIS Sponsor Handbook & Reference Materials 00:04:39

Exam and Certifications

  • Final Test – CTIS
  • Certification


What I will learn?

We will explain what is the Clinical Trial Information System and why it’s considered a Regulation’s business tool. Moreover, we will look into the implementation timelines and system user roles and responsibilities.

Skills I will gain

  • Learn about the Clinical Trial Regulation 536/2014 and the key benefits
  • Learn critical timeline implementation
  • Understand the CTIS as a business tool
  • Expand your knowledge of the CTIS roles and responsibilities, workspaces, and additional training materials


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