This e-learning program has been developed and curated by Clinical Validation for Biopharmaceutical Findings.

This course is specifically designed for investigators and research teams to navigate the evolving landscape of clinical research. Our focus is the ICH E6 (R3) guideline, which represents a significant modernization of Good Clinical Practice standards.

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Course Structure
Our course is divided into three modules, each building on the last:
Module I – What is a Clinical Trial? We start by understanding the clinical trial and how the research landscape is evolving under the new R3 framework.
Module II – The 11 GCP Principles Here we focus on the core principles, exploring how Quality by Design and risk-based approaches guide the trial process.
Module III – Annex I Finally, we put theory into practice, looking at the operational requirements for interventional trials in this updated regulatory era.

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Learning Objectives
By the end of the course, you will:
Understand the key principles of GCP R3 and how they apply to clinical research practice.
Recognize the investigator’s responsibilities in maintaining ethical standards and protocol compliance.
Learn the basics of data governance to safeguard data integrity, confidentiality, and regulatory adherence.
Understand the controls and requirements for computerized systems used in clinical trials.
Identify and manage essential documents to ensure complete and traceable trial documentation.