Abstract

This article describes a multistakeholder collaboration to translate the revised ICH E6(R3) (2025) guideline for good clinical practice (GCP) into Finnish. For this project, the Finnish Medicines Agency (Fimea) convened an ad hoc working group comprising experts from regulatory authorities, pharmaceutical industry, academia, public and private healthcare sectors, and the national ethics committee.

The aim was to create a clear, understandable and accessible Finnish translation of the updated GCP guideline to support clinical trial professionals, especially those working in academic settings and those new to clinical trials. The working group was tasked with ensuring that the translation is appropriate for the Finnish context and uses terminology consistent with current national and European legislation. Attention was paid to language-specific nuances as well as new terminology arising from the latest guideline revision, reflecting the evolving clinical trial ecosystem.

By taking contextual factors into account and clarifying newly introduced terminology, the translation is expected to facilitate the smooth conduct of clinical trials in Finland. This article summarises the process and outcomes of the translation and terminology project, providing an example of multistakeholder collaboration to advance a shared understanding of a well-established international guideline in a national context.