What does ICH E6(R3) Annex 2 mean for multilingual clinical trials? Explore what changes for localization and how Montero can support your trial.
Clinical trials are no longer confined to the trial site.
A visit may happen at a participant’s 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.
Trials haven’t just become more digital. They’ve 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.
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’t prescribe how multilingual clinical content should be managed. But it does give global trial teams a reason to ask themselves:
If the architecture of clinical research is changing, should we rethink the architecture of its multilingual content too?
Clinical Trials Are Changing. Annex 2 Reflects How.
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.
In practice, trial activities may take place at participants’ homes or local healthcare facilities. Visits 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.
As those activities spread across more locations and people, so does the information they rely on.
Distributed Trials Change How Information Moves
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.
Now imagine that ecosystem spans five countries and eight languages.
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.
As those touchpoints multiply, the priority shifts from translating more content to keeping all of it connected.
A Source Change Rarely Stays in One Place
Imagine that an instruction provided to participants needs to change during a study. The immediate question might be: Has the new version been translated?
But in a distributed multilingual trial, that’s only the beginning. A more useful question may be: Where else does that change need to appear?
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.
Suddenly, a seemingly simple source update becomes a question of terminology management, version control, and content dependencies.
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Keeping connected content consistent.
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.
Version control plays a similar role. When source content changes, multilingual teams need to know what changed and where that change needs to propagate.
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.
Localization Shouldn’t Be the Last Step in a Distributed Trial
Multilingual content is easy to picture as a linear process: create, approve, translate, distribute. But that model breaks down when content spans multiple systems, changes during a study, and needs to reach different users in different markets.
Planning for multilingual content from the start means asking practical questions:
- Which content will need localization, and how frequently could it change?
- Which materials share terminology or information?
- When the source changes, how does that update reach every language it needs to?
If a trial is designed to operate across markets, its content should be designed to travel across them too.
Design the Language Layer with the Trial
ICH E6(R3) Annex 2 doesn’t tell sponsors how to build a localization workflow. Instead, it recognizes a clinical research environment with more flexibility in where activities happen, how data is collected, and who is involved.
For global studies, that evolution gives us a reason to reconsider where multilingual content fits. Translation doesn’t have to be something added once everything else has been decided. The language layer should be designed around the content, systems, and users, with room to adapt as the trial evolves
Because when the trial moves, its information has to move with it.
Planning a global clinical trial? Let’s talk about your multilingual content.
