What does ICH E6(R3) Annex 2 mean for multilingual clinical trials? Explore what changes for localization and how Montero can support your trial.<\/p>\n
Clinical trials are no longer confined to the trial site.<\/p>\n
A visit may happen at a participant\u2019s home. Data may come from a wearable or an electronic health record. A local healthcare professional may carry out an activity once handled at the site.<\/p>\n
Trials haven\u2019t just become more digital. They\u2019ve become more distributed, with information moving between more people, technologies, locations, and data sources. And all the content that supports those activities has to move with them.<\/p>\n
The recently adopted ICH E6(R3) Annex 2 reflects this changing reality. It addresses trials incorporating decentralized elements, pragmatic elements, and real-world data. It doesn\u2019t prescribe how multilingual clinical content should be managed. But it does give global trial teams a reason to ask themselves:<\/p>\n
If the architecture of clinical research is changing, should we rethink the architecture of its multilingual content too?<\/strong><\/p>\n ICH E6 has long provided the international Good Clinical Practice framework for designing, conducting, and reporting clinical trials. Adopted on June 3, 2026, Annex 2 of E6(R3) responds to changes in how trials are run and how their data is collected.<\/p>\n In practice, trial activities may take place at participants\u2019 homes or local healthcare facilities. \u00a0Visits may be conducted remotely by video or telephone, and data may come from electronic health records, digital health technologies, wearables, or sensors. The guideline also recognizes that different parties may carry out trial activities.<\/p>\n As those activities spread across more locations and people, so does the information they rely on.<\/strong><\/p>\n Depending on the design of a study, information may need to move between sponsors, investigators, clinical sites, healthcare professionals, service providers, participants, and digital platforms.<\/p>\n Now imagine that ecosystem spans five countries and eight languages.<\/strong><\/p>\n Localization can no longer be viewed as a stage where a finished document is sent out for translation. The language layer can touch multiple parts of the trial ecosystem, serving different people, purposes, and channels.<\/p>\n As those touchpoints multiply, the priority shifts from translating more content to keeping all of it connected.<\/p>\n Imagine that an instruction provided to participants needs to change during a study. The immediate question might be: Has the new version been translated?<\/strong><\/p>\n But in a distributed multilingual trial, that\u2019s only the beginning. A more useful question may be: Where else does that change need to appear?<\/strong><\/p>\n Related materials may use the same terminology. Localized versions may already exist across different platforms and markets, while other content may depend on the information that has just changed.<\/p>\n Suddenly, a seemingly simple source update becomes a question of terminology management, version control, and content dependencies.<\/p>\n A termbase, for example, does more than tell translators which term to use. It creates a common reference across content and languages. This helps teams maintain consistency as information moves between documents, platforms, and audiences.<\/p>\n Version control plays a similar role. When source content changes, multilingual teams need to know what changed and where that change needs to propagate.<\/p>\n None of these challenges is unique to trials incorporating decentralized elements. But a more distributed trial environment creates more potential touchpoints for content and data. That can make the connections between them much harder to ignore.<\/p>\n Multilingual content is easy to picture as a linear process: create, approve, translate, distribute<\/strong>. But that model breaks down when content spans multiple systems, changes during a study, and needs to reach different users in different markets.<\/p>\n Planning for multilingual content from the start means asking practical questions:<\/strong><\/p>\nClinical Trials Are Changing. Annex 2 Reflects How.<\/h2>\n
Distributed Trials Change How Information Moves<\/h2>\n
A Source Change Rarely Stays in One Place<\/h2>\n
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Keeping connected content consistent.<\/strong><\/h3>\n<\/li>\n<\/ul>\n
Localization Shouldn\u2019t Be the Last Step in a Distributed Trial<\/h2>\n