CVBF is proud to announce the launch of ClinicalResearch.Education, a new dedicated e-learning platform developed to deliver high-quality, accessible training to clinical research professionals across Europe and beyond.

As its inaugural offering, the platform presents the Good Clinical Practice Course for Investigators – ICH GCP E6 (R3), a comprehensive online training programme specifically designed for investigators and research teams navigating the updated regulatory landscape of clinical trials.

The course has been developed and curated by CVBF, building on more than 25 years of expertise in clinical research coordination, training, and regulatory affairs.

The release of the ICH E6 (R3) guideline marks the most significant modernisation of Good Clinical Practice standards in a generation. It introduces a stronger emphasis on Quality by Design, risk-based approaches, data governance, and the integrity of computerised systems used in clinical trials. Investigators are at the heart of this transformation, and their training must reflect it.

Course structure and features

The GCP R3 Course for Investigators is structured across three progressive modules:

  • Module I – What is a Clinical Trial? An introduction to the clinical trial framework and the evolving research landscape under the R3 paradigm.
  • Module II – The 11 GCP Principles An in-depth exploration of the core principles, with a focus on Quality by Design and risk-based monitoring.
  • Module III – Annex I Operational requirements for interventional trials in the updated regulatory era.

The course content is delivered through an immersive narrated and animated video, which guides participants through each concept in a clear and engaging way, making even complex regulatory content easy to follow and retain. Participants also receive the full written version of the course material as a study companion and lasting reference.

To reinforce learning, interactive quizzes are embedded throughout, four in total. Upon successful completion of the course, participants receive a certificate, which meets the Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, enabling mutual recognition of GCP training among trial sponsors.

The course takes approximately 2 hours and 30 minutes to complete and is available at a one-time enrolment fee of €45 per person.

Learning objectives

By the end of the course, participants will be able to:

  • Understand the key principles of GCP R3 and their practical application in clinical research;
  • Recognise the investigator’s responsibilities in maintaining ethical standards and protocol compliance;
  • Apply the basics of data governance to safeguard data integrity, confidentiality, and regulatory adherence;
  • Understand the requirements for computerised systems used in clinical trials;
  • Identify and manage essential documents to ensure complete and traceable trial documentation.

A new home for clinical research education

The launch of ClinicalResearch.Education reflects CVBF’s long-standing commitment to strengthening the quality and professionalism of clinical research across Europe. The platform is designed to grow, with further courses planned to address the diverse training needs of the clinical research community – from research nurses and data managers to ethics committee members and sponsors.

We invite all investigators, site staff, and clinical research professionals to explore the platform and enrol in the GCP R3 course.

👉 Access the course: clinicalresearch.education

For further information, please contact us at [email protected]

About the Author: Flogert Dollani

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