1.1 GCP Summary, Structure of Documents & Core Quality Concepts

Welcome to this module on GCP Summary, Structure of Documents, and Core Quality Concepts. In this session, we’ll briefly review the key principles of Good Clinical Practice, understand how GCP documents are structured within the ICH E6 guideline, and explore the core quality concepts that ensure data reliability and participant safety. You’ll gain a clear view of how GCP is organized, how its sections connect, and why quality management and risk-based approaches are central to every clinical trial. Let’s get started.