The context
Clinical-trial consent materials must explain complex medical procedures, possible benefits, known and unknown risks, participant rights and study requirements in language that supports an informed decision.
This assignment involved a study of an investigational treatment used alongside chemoradiation for adults with locally advanced head and neck cancer. The document package addressed the participant's main consent, pregnancy-related follow-up and withdrawal from the study.
For Kabuverdianu-speaking participants, accessibility depended on more than converting English sentences into another language. The content needed to remain clinically accurate and institutionally appropriate while using Kabuverdianu that was clear, natural and consistent for speakers of the Santiago dialect.
The objective was to preserve the meaning, structure and level of certainty of the approved English source across three interconnected consent documents.
The challenge
The package combined clinical terminology, research procedures, ethical and legal information, reproductive-risk language and document-specific instructions. Decisions made in one document could affect terminology and interpretation in the other two.
- Preserve the meaning and structure of the approved source.
- Communicate specialist information in participant-facing language.
- Maintain one terminology system across three related consent documents.
- Distinguish carefully between standard care, study procedures and investigational treatment.
- Preserve the source's distinctions between possible, known and unknown risks.
- Handle sensitive content concerning pregnancy, genetics, biological samples, privacy and withdrawal from research.
- Apply ALUPEC consistently while using natural Kabuverdianu for the Santiago dialect.
- Preserve tables, response options, signatures and internal references across 60 pages.
- Avoid adding explanations, assurances or interpretations not present in the source.
Scope and responsibility
Janilson M. Semedo was responsible for the complete linguistic workflow from English (United States) into Kabuverdianu — Santiago dialect.
The responsibility extended beyond individual segments. The three documents needed to function as one coherent consent system, with consistent terminology and no contradiction between the main consent, the pregnant-partner consent and the withdrawal addendum.
- Translation of a 41-page main informed-consent form.
- Translation of a 12-page pregnant-partner consent form.
- Translation of a 7-page withdrawal addendum.
- Editing and proofreading across the complete package.
- Terminology review and cross-document consistency checks.
- Application of ALUPEC conventions.
- Linguistic quality assurance in Trados Studio.
- Independent verification in Xbench.
- Final completeness and formatting review before delivery.
Translation and quality process
- Package review: The three documents were reviewed as a connected set to identify repeated language, clinical terminology, internal references and sections requiring cross-document alignment.
- Terminology planning: Key concepts relating to treatment, chemotherapy, radiotherapy, imaging, adverse events, reproductive risks, privacy, genetic research, biological samples and participant rights were evaluated in context.
- Translation in Trados Studio: The content was translated while preserving segment relationships, formatting, repeated language and the structure of the approved source.
- Editing and proofreading: The complete package was reviewed for accuracy, clarity, fluency, grammar, ALUPEC usage and suitability for participant-facing communication.
- Cross-document review: Terminology and instructions were compared across the main consent, pregnant-partner consent and withdrawal addendum to prevent inconsistency between related decisions.
- Trados QA: Automated checks were used to identify potential omissions, number inconsistencies, repeated-segment differences, punctuation problems and formatting issues.
- Xbench verification: A separate QA pass was completed in Xbench to examine terminology, numbers, consistency and potential errors before final delivery.
- Final verification: The final review confirmed completeness, file integrity and the correct preservation of names, structured fields and internal references.
Verified evidence
- 15,665 source words.
- 60 pages across three related consent documents.
- English (United States) to Kabuverdianu — Santiago dialect.
- ALUPEC-based orthographic approach.
- Main informed consent, pregnant-partner consent and withdrawal addendum.
- Complete translation, editing and proofreading workflow.
- TEP and formal linguistic quality assurance.
- QA completed first in Trados Studio and then in Xbench.
- Delivered ahead of the agreed deadline.
- Accepted without revisions.
Outcome
The complete Kabuverdianu package was delivered ahead of the agreed deadline and accepted without revision requests.
The outcome claimed here is linguistic and operational: three interconnected consent documents were translated, edited, proofread and quality-checked as one consistent package for Kabuverdianu-speaking participants.
No claim is made about participant recruitment, clinical outcomes, regulatory approval or the subsequent use of the materials because those results were outside the scope of the language assignment.
Confidentiality and attribution
This project was delivered through Northwest Translations, Inc.
This case study demonstrates the nature, scale and professional responsibility of the work without publishing source documents, translated segments, participant information, rates or confidential study data.
The sponsor, research site, investigator, investigational product, protocol and ethics-review identifiers are withheld. No third-party logo is used, and the case study does not imply a direct contractual relationship with the pharmaceutical sponsor or participating research site.