Clinical Operations Courses

You need to update and to refresh your knowledge on ICH-GCP, including the recently released ICH-GCP E6 (R2) Addendum 2016 and its implementation and you want to do it in a very practical and useful way? Then this eLearning course is designed for you.

How is this course different from usual refresher sessions? It is conducted in a very interactive way to review ICH-GCP through workshops, quizzes and real-life situations.

This eLearning course is designed for professionals who already have knowledge of the International Council on Harmonization and Good Clinical Practice (ICH-GCP) standards, but need to be up-to-date up to the items added in 2016. It is designed as a refresher on ICH-GCP and will cover the responsibilities of all players in the clinical research field. This refresher session is a very interactive course which will allow YOU to verify the extend of your knowledge on ICH-GCP and complete the potential gap.

Interactive quizzes and exercises for self-assessment are included to provide a better understanding of each part of the course. You will be able to test your comprehension with a final grading assessment.

All ECCRT eLearning courses include a touchpoint with the trainer to discuss open questions from any student. Continuous interactivity with the trainer and fellow students is also encouraged through the ECCRT Virtual Campus Discussion Forum.

This ICH-GCP training is recognised by the Swiss Association of Ethics Committees for clinical trials as training for investigators and sub-investigators of clinical trials in Switzerland.

Course time
09h00 - 13h00
Who should attend

Everyone who wants to refresh their knowledge of the current regulations and GCP in clinical studies. Prior training or working experience in a GCP environment is required.

Programme highlights
  • Principles of GCP
  • Responsibilities for all involved persons/parties
  • The essential GCP-related documents
  • GCP Common Audit Findings & practical tips to help you avoid them
  • Introduction to the new GCP additions
    • Risk Based Quality Management Characteristics and Steps
    • Elements of Risk Based Monitoring
    • New Aspects Related to Supervision
    • Effect of Digital Technology
    • Changes and impact for Investigators and for Sponsors

Click the link to open the Course Programme and get detailed information about the course structure and chapters duration.

Learning Objectives
  • Refresh the GCP requirements in clinical research and how they are implemented
  • Understand the essential documents of clinical studies
  • Grasp what GCP implies for all clinical trial stakeholders, including for you in your daily work.
  • Know how to avoid findings in case of audit and/or inspection
  • Acquire a clear view of all items added to the parental ICH-GCP guideline
  • Be prepared to implement the new requirements in your clinical research activities
  • Understand the impact of the recently released ICH-GCP E6 (R2) Addendum 2016

Book a course

No session currently available.
In case of interest, please contact us.


Liesbeth Fagard
August 2017

Interactive, room for questions/debate which ensures to keep our attention all day for this very theoretical content of the course.