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Abstract

<jats:p>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.</jats:p>

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research course principles e6r3 process

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