ICH Good Clinical Practice E6(R3) Training course (Global Health Network)

2025
Category
  • Execute
  • Quality Management

This online ICH Good Clinical Practice E6(R3) course from The Global Health Network shows how the revised ICH GCP guideline applies in everyday clinical research, from study design to close‑out, with a focus on participant protection, risk‑proportionate quality and ethics. It targets a broad audience including clinical researchers, data managers, monitors, quality assurance staff, sponsors, ethics committee members and regulators. The course is free, self‑paced and requires registration on the Global Health Training Centre website. It meets the “Minimum Criteria for ICH GCP Investigator Site Personnel Training” defined by TransCelerate BioPharma. Sequential modular structure; each module can be accessed independently. Linked resources and a glossary support deeper study.

The course consists of a preface plus eight online modules (total duration about 180 minutes):

Preface – evolution of Good Clinical Practice and course overview
Module 1 – Introduction to Good Clinical Practice in research
Module 2 – The 11 principles of Good Clinical Practice
Module 3 – Roles and responsibilities of stakeholders in Good Clinical Practice
Module 4 – Applying principles in planning and study design
Module 5 – Applying principles at study initiation
Module 6 – Applying principles during conduct and risk management
Module 7 – Applying principles at conclusion, closure and post‑study activities
Module 8 – Summary of principles and final reflections

On completion, participants should understand Good Clinical Practice principles and their relevance, apply participant‑centred, risk‑based and quality‑focused methods, and adapt Good Clinical Practice across different settings and designs. A final assessment is included; successful learners receive a downloadable certificate of completion.