​​​​Module 1.1 Overview

This module provides an overview of the guideline, highlights the relationships between the GCP Guideline and other ICH efficacy guidelines, and introduces the learner to important terms and concepts found in the guideline.

Key questions you should be able to answer by the end of this module include:

• What is good clinical practice or GCP?
• What is the structure of the GCP Guideline?
• What are the underlying concepts behind the E6(R3) revision?

Module 1.2 Principles of ICH GCP

This module explores the principles of the ICH GCP Guideline, highlighting selected points from each principle.

Key questions you should be able to answer by the end of this module include:

• What are the ICH GCP principles?
• Where in the annexes are there more details to help apply these principles effectively?
• How are the GCP principles practically applied in actual clinical trial scenarios?

Module 1.3 Foundational Concepts

This module provides the learner with an in-depth understanding and practical application of the foundational concepts of designing and conducting clinical trials.

Key questions you should be able to answer by the end of this module include:

• How do you proactively build quality into the scientific and operational design and conduct of a clinical trial?
• How do you identify critical to quality factors and identify, prioritise and manage the risks that may impact them?
• How can engaging relevant parties help to identify critical to quality factors and their risks?