Running a medical translation project

A medical translation project needs a workflow matched to its documents, an effective route for queries and clear authority over terminology and review comments. Agency and in-house arrangements can distribute these responsibilities differently.

Workflows for different document groups

A clinical-study translation agency's 2024 work included lay summaries, patient-facing documents, audit reports, protocols and synopses, ethics-committee correspondence, legal documents, training materials, quality-of-life questionnaires and press releases. ¹ Its workflows differed by document group. ^{2, 3, 4}

For lay summaries and lay synopses, translation memory and terminology needed to be current, and wording understandable to non-medical readers; some clients also requested gendered forms where relevant and possible. ⁵ Back translation and master review were followed by country review, where client representatives read and approved the text in their native language, then desktop publishing and layout checking, often involving translators to identify typos or stray spacing. ^{5, 6}

In 2024, the agency's ethics-committee letters had moved from supplied PDFs to downloads from the Clinical Trials Information System, making preprocessing harder. ⁶ Templates and file preparation were needed before computer-assisted translation, with consistent translations of study titles and authority names. ²

For patient-facing material, including consent forms and protocol synopses, the agency had begun asking medical writers to rewrite source text for the intended audience before translation. ^{2, 3} Similar consent forms for adults, children or adolescents could be translated in two batches, using repetitions from the first batch in the second to speed the work. ³ Electronic case-report-form exports also required file preparation before translators received them in their translation tools. ⁴

Queries before delivery

Translators are expected to deliver one final translation ready for use, so questions should be raised during the process rather than when the final version is due. ⁷ Questions about individual word choices are expected during translation, whereas other medical communication may require review of the whole document before clarification; a good translation needs few final client corrections. ⁷

Medtronic's in-house team reported in 2024 that direct contact through company chat could produce a writer's answer within five or ten minutes. ^{8, 9} Linguists were expected not to close a task or complete revision while a question remained unanswered, even if this delayed the project. ^{10, 11} Educating writers and management about response times had brought typical answers within a few hours. ¹¹ Direct contact also let the team explain realistic turnaround times and arrange support for genuinely urgent work. ^{9, 12}

Terminology agreed with the client

A client-supplied bilingual glossary and clarification of terminology during the work can help meet client expectations. ^{13, 14} Where no glossary exists, an experienced translator can build one during the first project and expand it through later assignments for the same client. ¹³

In-house review responsibilities

Medtronic's 2024 workflow began with inspection for potential questions or project issues, followed by translation and revision by different linguists, then coordination with an in-country subject matter expert (SME). ^{8, 15} The business unit identified a company employee who spoke the target language, assigned the role as part of their work and arranged an explicit discussion of expectations with the translation team. ^{16, 17}

These reviewers checked whether terminology and tone matched company usage with patients and healthcare providers in that country, rather than editing or correcting the translation. ^{16, 17} The team preferred reviewers without translation experience because some translators had overstepped that limited review role. ^{18, 19} The translation linguists themselves were native speakers with extensive medical-translation backgrounds or previous healthcare careers, but could lack knowledge of local company usage. ^{16, 20}

Reviewers returned approval or comments, and comments went back to the linguist who performed revision. ²⁰ Marketing comments were implemented without adjudication, whereas for technical documents used by patients or healthcare providers, the linguist accepted or rejected each comment according to its consequences for meaning and consistency with translation memory or released documents. ^{20, 21} A request that would introduce inconsistency could be rejected as preferential. ²¹

In one Romanian dispute about infusion-set terminology, Medtronic required its documented, established country usage despite linguists judging the term medically inappropriate. ²² Experienced linguists also acted as experts within the translation team: some had worked with it for over twenty years and could retrieve earlier decisions, including a 2005 discussion explaining a term. ²³

Delivery and turnaround

In 2024, Medtronic’s department had existed in its current form for about thirty years, and some processes had not kept pace with newer technology. ^{24, 25} It was adapting the workflow to tight release deadlines through three approaches. ²⁵

• Follow-the-sun handovers, for example from the United States to Tokyo and then another location as working days changed.
• Internal education about the difference between urgent and priority work, because not every project could be the top priority.
• Introducing machine translation and a more flexible workflow model to shorten the standard process.

²⁵

A language-services provider reported automating ethics-committee and authority formatting conventions, such as footers, file names and bookmarks, to save billable time and avoid errors from repetitive manual work. ²⁶