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Structure and Duration: Certification: Languages: Related Resources: QUESTION SETTING AND STUDY DESIGN STUDY IMPLEMENTATION AND OPERATIONS RESEARCH MANAGEMENT AND GOVERNANCE |
The Global Health Network’s International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6(R3) course has been fully restructured to reflect the latest updates to the ICH E6(R3) GCP guidelines, with the final version published on January 6, 2025.
About this course
This course accompanies the evolution of the ICH GCP guidelines. In this new version, the course is structured so that it allows learning to take place in a more natural and practical way, where the principles of GCP E6(R3) are not learned in isolation, but integrated into real situations of each phase of the research process.
This course is designed to help participants, especially those with less experience, see how GCP principles inform every key decision in a study, from design to closure, with an emphasis on justice, equity, and applied ethics. With this restructuring, it is ensured that the content is aligned with the latest international standards, providing a solid and up-to-date foundation for those seeking excellence in research practices.
Implementing this approach has the potential to increase the number of high-quality studies led by local researchers, enhance research equity, and ensure that evidence generation is responsive to contextual needs. Moreover, effective adaptation of the updated Good Clinical Practice Guideline (ICH GCP E6(R3)) to local regulatory frameworks, alongside efforts to strengthen research capacity, necessitates a flexible, collaborative, and informed process. This should ideally engage regulators, investigators, community representatives, and ethics committees from the outset.
Learning Objectives
Upon completion of this course, participants are expected to:
- Understand the basic principles of GCP and its relevance to clinical research
- Apply participant-centred practices, adequate risk management, and quality in the design and execution of clinical trials
- Adapt GCP practices in diverse research environments and other study designs
Target Audience
The target audience of this course is wide and includes clinical researchers and members of research teams such as data managers, monitors and quality assurance personnel, as well as sponsors, ethics committee members and professionals in regulatory agencies involved in clinical research.
Congratulations, you are about to start a free, high-quality, peer-reviewed training and internationally recognised training course.
It’s core to The Global Health Network to ensure that no researcher is held back by cost, this is why they are free to everyone. But making these courses isn’t free. It takes time, expert input, technology, and dedicated teams working behind the scenes—so others like you, anywhere in the world, can access trusted, career-advancing training.
If you can, please support us with a donation of £15. That’s the cost of producing this course, per student. Every contribution helps us keep this open to everyone, and you are helping those who cannot afford to pay.
HELP KEEP GLOBAL RESEARCH EQUITABLE
Course contents
Module |
Title |
Action |
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Preface |
The evolution of Good Clinical Practice and Course Overview |
Begin module |
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Module 1 |
Introduction to Good Clinical Practice (GCP) Applied to Research |
Begin module |
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Module 2 |
The 11 principles of Good Clinical Practice |
Begin module |
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Module 3 |
Key Stakeholders in Clinical Research: Roles and Skills for the Application of Good Clinical Practice Principles |
Begin module |
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Module 4 |
Principles applied in the Planning and Design of the Study |
Begin module |
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Module 5 |
Principles applied in the Initiation of the Study |
Begin module |
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Module 6 |
The principles applied in the Execution of the Study and in Risk Management |
Begin module |
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Module 7 |
Principles applied in Conclusion, Closure and Post Study |
Begin module |
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Module 8 |
Summary of principles and final reflections |
Begin module |
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Additional Resources |
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Browse Resources |
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Glossary |
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Glossary |
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Acknowledgements
Editors
Daniela Morelli, GRN/LAC Regional Manager, The Global Health Network, University of Oxford, UK; Associate Researcher at Institute for Clinical Effectiveness and Health Policy; Member of the Independent Ethics Committee of Health Region V, Province of Buenos Aires
Fernando Rubinstein, Training lead, The Global Health Network, University of Oxford, UK
Instructional Design
Kehkashan Shah, Training Officer, The Global Health Network, University of Oxford, UK
Graphic Design
Steffani Herring, Digital Content Development Officer, The Global Health Network, University of Oxford, UK
Reviewers (alphabetical order)
Brian Ngwira, Clinical Research Support Unit Lead, Malawi-Liverpool-Wellcome Programme (MLW)
Farah Asif, Clinical Research Administrator, Shaukat Khanum Memorial Cancer Hospital and Research Centre, Pakistan
Moira Dolera, Lembeye Lawyer specialising in Health Law, Bioethics, Disability, and Insurance. Member of the Independent Ethics Committee of Health Region V, Province of Buenos Aires. Founding member of the Institute of Health Law at the San Isidro Bar Association. Legal consultant and advisor in Health Law and Corporate Law
Roxana Lescano, JD, Peruvian Association for the employment and Welfare of Animals in Research and Teaching (ASOPEBAID in Spanish), past president, Peru
Yiyun Shou, Saw Swee Hock School of Public Health and Lloyd's Register Foundation Institute for the Public Understanding of Risk, National University of Singapore
Support and collaboration
Haydn Whitehouse-Lloyd, Team Assistant, The Global Health Network, University of Oxford, UK
Kapil Narain, DPhil Student, University of Oxford, UK
Source Material
This course is based on International Conference on Harmonisation’s (ICH) 2023 guidelines for Good Clinical Practice Revision 3 (R3).
Use and reproduction of these eLearning materials
These e-learning materials are owned by The Global Health Network. You are free to share or adapt but you must attribute it to The Global Health Network using the link tghn.org
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This ICH E6(R3) GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. |
