VIAXCorporate Language Solutions

Linguistic Validation

Linguistic validation for clinical outcome assessments

VIAX manages the translation and linguistic validation of clinical outcome assessments, patient-reported outcome measures and other clinical instruments across multiple languages. Each project follows a documented process from forward translation through final review and certification.

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  • 40+ clinical measures completed
  • Experience since 2010
  • Signed LV Certificate

Clinical instruments

Content we work with

  • Clinical Outcome Assessments

    Clinical instruments used to measure symptoms, functioning, quality of life and other health outcomes.

  • Patient-Reported Outcomes

    Measures completed directly by patients to report their symptoms, experiences or quality of life.

  • Quality-of-life questionnaires

    Questionnaires used to assess the effect of a condition or treatment on a patient’s daily life.

  • Symptom scales

    Measures used to record the presence, frequency or severity of specific symptoms.

  • Patient diaries

    Daily or periodic patient records used to collect information during a study.

  • Other patient-facing clinical materials

    Supporting materials that require clear and consistent language for the target population.

Conceptual equivalence

Keeping the same concept across languages

The target-language version should express the same concept as the source while remaining clear and natural for the target population. Linguistic validation uses several independent review steps to identify changes in meaning before the final version is approved.

Validation process

From first translation to final version

  1. 01

    Two independent forward translations

    Two specialist translators produce separate translations of the source instrument.

  2. 02

    Reconciliation

    The two translations are compared and combined into one version. Translation choices and differences are reviewed and documented.

  3. 03

    Blinded back translation

    A separate linguist translates the reconciled version back into the source language without seeing the original text.

  4. 04

    Translation quality assessment

    The source, translations and back translation are compared to identify any change in meaning and confirm conceptual equivalence.

  5. 05

    Cognitive debriefing when required

    The translated instrument can be tested with people from the target population to check whether the questions and response options are understood as intended.

  6. 06

    Clinician review when required

    A clinician or other relevant healthcare professional reviews the translated instrument where the project protocol requires specialist clinical input.

  7. 07

    Final version & certificate

    Findings from the agreed review stages are incorporated into the final version. A signed Linguistic Validation Certificate is issued when the project is completed.

The exact validation process is agreed for each project. Cognitive debriefing, clinician review and other additional steps are included when required by the sponsor, instrument owner or project protocol.

Multilingual studies

One process across multiple languages

VIAX can coordinate the same validation process across several target languages within one project. Languages follow the same documentation structure, project schedule and review requirements.

  • One project manager

    A single VIAX contact coordinates the languages, files, questions, deadlines and deliverables.

  • Local specialists

    Each target language is handled by linguists and in-country specialists selected for the project.

  • Shared documentation

    Common templates and review steps make it easier to follow decisions across languages.

  • Coordinated deadlines

    Language schedules are planned together so the client can track the whole project in one place.

Documentation

A clear record of the project

The documentation is agreed before work starts and records the main linguistic decisions made during validation.

  • Forward translation & reconciliation record

    Shows the independent translations, final choices and relevant comments.

  • Back translation

    Provides an independent source-language version for comparison with the original.

  • TQA report

    Records the review of meaning, terminology and conceptual equivalence.

  • Cognitive debriefing report

    Documents participant feedback and any resulting changes when cognitive debriefing is included.

  • Clinician review record

    Documents specialist clinical feedback and any resulting changes when clinician review is included.

  • Final validated version

    The approved target-language instrument after all agreed review steps are complete.

  • Linguistic Validation Certificate

    A signed certificate confirming completion of the agreed linguistic validation process.

Experience

Linguistic validation since 2010

  • 40+

    Clinical measures completed

  • 2010

    Linguistic validation work since

  • Multiple

    Therapeutic areas

  • Multi-language

    Project coordination

Therapeutic areas

Experience across clinical fields

  • Rheumatology

  • Oncology

  • Pain & general health

  • Diabetes & metabolic disorders

  • Gastroenterology

  • Neurology & fatigue

  • Paediatrics & allergy

  • Orthopaedics

Specialist experience

Managed by an experienced LV project manager

The VIAX linguistic validation service draws on Vladka Sokolova’s experience managing linguistic validation projects since 2010. Her work covers more than 40 completed clinical measures across a range of therapeutic areas and multilingual projects.

Vladka Sokolova

Linguistic Validation Project Manager

ISOQOL Member

View specialist LV profile

Related services

Tell us about your instrument.

Send us the source instrument, target languages, timeline and any project requirements you already have. Let us know whether cognitive debriefing or clinician review is required. We’ll review the scope and come back to you with the process, timing and cost.

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