Regulatory Courses

You are a clinical research professional, investigator, monitor or other staff active in the field of clinical research; then you need to comply with the Good Clinical Practice guideline, including the recently released ICH-GCP E6 (R2) Addendum 2016.

You are looking for insights on the ICH-GCP E6 (R2) Addendum 2016, including how the changes will affect your daily work and you want to get to know all new requirements in a practical and useful way?
Then this 1.5 hour eLearning course is designed for you.

How is this course different from usual sessions? It is conducted in a very interactive way to review ICH-GCP addenda through quizzes and examples.

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 about the items added in 2016. It is a short and very specific course on the ICH-GCP E6 (R2) Addendum 2016. All new elements of the latest GCP version are explained and presented in a clear-cut way.

This eLearning is an interactive which will allow YOU to verify the extend of your knowledge on ICH-GCP E6 (R2) Addendum 2016 and complete the potential gap. 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.

Learn at your own pace: the course will remain available online for you for 3 months after you register for it.

Course time
At your own pace; the course will remain available online for you for 3 months after you register for it ------------- Course Credits: 1.5 hours
Who should attend

Everyone who wants to complete their ICH-GCP knowledge on the recently released ICH-GCP E6 (R2) Addendum 2016. Prior training on ICH-Good Clinical Practice is required.

Programme highlights
  • Introduction to the new GCP additions
  • Focus on Risk Based Quality Management
  • Elements of Risk Based Monitoring
  • New aspects related to Supervision
  • Effect of new digital technologies
  • 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
    • Acquire a clear view of all items added to the parental ICH-GCP guideline
    • Understand risk based quality management and risk based monitoring specifications
    • Gain knowledge about the current computer validation requirements
    • Grasp what is newly required for the investigator as well as for the sponsor
    • 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



    This course covers competencies that are part of the ECCRT Competency Framework

    • Scientific Concepts & Research Design (1)
    • Ethical & Participants Safety Considerations (1)
    • Investigational Product Development and Regulation (2)
    • Clinical Studies Operations (GCPs or ISO 14155) (5)
    • Study and Site Management (5)
    • Data Management and Informatics (6)
    • Leadership and Professionalism (0)
    • Communication (0)
    • Teamwork (0)
    • Business acumen (0)

    Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained

    Book a course

    Date Lang Location
    * Book now and learn at your own pace within the next 3 months
    Proceeding your application may take up to 24 working hours. In case of question, contact
    100,00 € excl. VAT (if applicable)