A CRO requested the translation of key clinical trial documents into Bulgarian, Serbian, Romanian, Hungarian, Greek, Slovak, Slovenian, Estonian, Latvian and Lithuanian. The documentation package included:
- Protocol Synopsis
- Laboratory Services Agreement
- Pharmacy Services Agreement
- Radiology Services Agreement
- Study Staff Agreement
The project combined scientific, clinical, operational and contractual content within the same clinical study. Each document required terminology and language appropriate to its individual purpose, while shared study terminology needed to remain consistent across the complete multilingual document set.
The Challenge
The challenge was not simply translating different document types. Scientific, operational and contractual content had to remain accurate within its individual context while shared study terminology remained consistent across ten languages and multiple documents.
The project required us to:
- Preserve scientific and clinical accuracy in the Protocol Synopsis while maintaining the appropriate legal and contractual meaning of the service and study staff agreements
- Maintain consistent study-specific terminology across documents, even where the same concepts appeared in different scientific, operational or contractual contexts
- Coordinate terminology across ten target languages while respecting established local clinical and legal usage
- Integrate previously approved study terminology and translations where available rather than introducing unnecessary variation
- Incorporate feedback from in-country client reviewers while maintaining consistency with the wider multilingual document set
- Ensure that terminology decisions were reflected consistently across the relevant documents, project glossaries and translation memories
Our Approach
At NN Translations, the project was managed within our ISO 9001 and ISO 17100-certified quality framework, with defined processes for linguist qualification, translation, independent revision, terminology management and quality assurance.
Specialised Native-Speaking Linguists
For each target language, we selected native-speaking translators and revisers with relevant experience in clinical trial, medical and legal content. Each translation was completed by a qualified translator and independently reviewed by a second native-speaking reviser.
Linguists were selected according to the requirements of the individual documents. Each linguist also completed our Subfield Experience Form, allowing us to verify relevant experience in scientific, clinical and contractual translation before assignment.
Terminology Management
A project-specific glossary was created to capture recurring clinical trial and study terminology, including terms such as Investigational Medicinal Product (IMP), Informed Consent and Principal Investigator.
Previously approved translations were incorporated where available, helping preserve continuity with existing study documentation.
Project glossaries and translation memories were updated throughout the project as terminology decisions were confirmed, providing a common reference point across the different documents.
Translation and Independent Revision
Each document followed a translation and independent revision workflow in accordance with our ISO 17100-certified processes.
The independent revision covered accuracy, completeness, terminology, clarity and consistency, as well as compliance with project-specific instructions and the Life Sciences Style Guide.
In-Country Review
For selected terminology and contractual wording, in-country client representatives reviewed and confirmed the proposed language.
Their feedback was incorporated into the project terminology resources where applicable so that confirmed terminology could be applied consistently across related documents.
Formatting and Language-Specific Conventions
The multilingual files were also reviewed for language-specific conventions, including:
- Localisation of decimal and thousand separators
- Treatment of references and bibliographic information according to project instructions
- Appropriate capitalisation and punctuation
- Consistent application of approved terminology across related documents
Document-Specific Considerations
Protocol Synopsis
Scientific and clinical terminology was handled consistently with the study context, while previously approved translations of study-specific content were applied where available.
Particular attention was given to maintaining clarity without altering the scientific meaning of the source content.
Laboratory Services Agreement
Contractual meaning was preserved while ensuring that laboratory and specimen-related terminology was expressed appropriately in each target language.
Recurring terminology was aligned with the wider study documentation to prevent unnecessary variation between documents.
Pharmacy Services Agreement
Clinical trial pharmacy terminology relating to areas such as storage, handling and dispensing was translated consistently while preserving the contractual requirements of the agreement.
Radiology Services Agreement
Specialised imaging terminology, including terms relating to contrast agents and computed tomography, was reviewed using appropriate terminology resources and maintained consistently throughout the documentation.
Study Staff Agreement
The translation needed to preserve the contractual meaning and responsibilities of study personnel while using terminology appropriate to the local clinical research context.
Where applicable, in-country reviewer feedback was incorporated to align wording with accepted local usage.
The Result
The project resulted in:
- Five document types successfully translated into ten languages and delivered within the agreed timeline
- Consistent study-specific terminology across scientific, operational and contractual documentation
- Translation and independent revision performed by native-speaking linguists with relevant subject-matter expertise
- In-country reviewer feedback incorporated into relevant terminology decisions
- Previously approved terminology maintained across the multilingual document set
- Project glossaries and translation memories updated to preserve terminology decisions for subsequent study documentation
- Completed multilingual documentation prepared for use by participating local study teams and sites
By combining native-speaking subject-matter expertise, independent revision, centralised terminology management and multilingual quality control within our ISO 9001 and ISO 17100-certified framework, NN Translations maintained consistency across documentation serving different functions within the same clinical study.
The project demonstrated the importance of treating a multilingual clinical trial documentation package as a connected set of study materials rather than a collection of unrelated translation files.
Planning a Multilingual Clinical Trial Documentation Project?
Talk to us about your study documentation, target countries and languages, existing translations and terminology requirements.
We support the translation and linguistic review of clinical trial protocols, informed consent forms, patient-facing materials, agreements and other study documentation within our ISO-certified quality framework.