You need to update and to refresh your knowledge on ICH-GCP, including the 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.
Course timeAt your own pace; the course will remain available online for you for 3 months after you register for it. ---------------- Course Credits: 4 hours
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.
- Refreshing Definitions and Principles of GCP
- Responsibilities for all involved persons/parties
- The essential GCP-related documents
- GCP Audit Findings at the Investigator as well as at the sponsor & tips to help you avoid them
- Changes by and impact of the 2016 GCP addendum for Investigators and for Sponsors
Click the link to open the Course Programme and get detailed information about the course structure and chapters duration.
- Refresh your knowledge on current 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
- Obtain a clear view on the impact of all items added by the ICH-GCP E6 (R2) Addendum 2016
- Know how to avoid findings in case of audit and/or inspection
Optional additional module:
In case you need to know more about the ICH-GCP Addendum 2016, a short extra module to this course can be taken, which details in particular:
- Risk Based Quality Management Characteristics and Steps
- Elements of Risk Based Monitoring
- Aspects Related to Supervision
- Computerised System Requirements
- Changes and impact for Investigators and for Sponsors