Linguistic validation is an end-to-end, structured process used to develop translated instruments for clinical trials and medical research. The objective is to ensure conceptual equivalence, cultural appropriateness, and content validity between the source and target languages.
Our process aligns strictly with international regulatory and industry guidance, including ISPOR best practice recommendations. Unlike standard translation, this rigorous approach supports the acceptability of translated instruments for regulatory submission and clinical use.
Translatability Assessment / Pre-Translation Analysis
Before translation begins, we conduct a translatability assessment to evaluate the source text for linguistic, cultural, or conceptual challenges. This step provides translators with critical context regarding the intended meaning, purpose or nuances of the original content.
This step also identifies areas that may cause ambiguity or misunderstanding in translation and highlights where further localisation or cultural adaptation may be required to ensure comprehension by the end user.
Role of the Translatability Assessment in Regulatory Compliance
A robust translatability assessment ensures data integrity by:
- Clarifying Concepts: Providing documented definitions to support consistent interpretation across all languages.
- Reducing Drift: Minimising the risk of concept drift in multi-country trials.
- Early Identification: Flagging necessary adaptations (e.g., units of measurement or cultural references) before translation starts.
- Mitigation Strategies: Proactively addressing non-translatable concepts that could affect the validity of the underlying measurement.
Linguistic Validation Translation Processes
For general content, simple translation may suffice. However, for COAs intended for regulatory use, you must guarantee that results are valid and comparable worldwide. Inaccurate translations can lead to rejected submissions, ethics committee delays, and unreliable patient data.
Comms Multilingual applies a structured linguistic validation workflow designed to ensure accuracy, consistency, and auditability.
Dual Forward Translation
Two independent forward translations are produced by qualified linguists working separately. This approach helps identify alternative phrasings and mitigates individual translator bias.
Reconciliation / Harmonisation
A third, senior linguist reviews and reconciles the dual forward translations, combining them into a single harmonised version that represents the most accurate and appropriate rendering of the source text.
Back Translation
We add an extra level of quality assurance to your linguistic validation translation processes by translating back into the source language. This back translation is used to verify conceptual equivalence and ensure the original meaning has been preserved.
Quality Assurance
Once the initial test translation is complete, we use a combination of experienced human checkers and linguistic software tools to assess accuracy, consistency, terminology usage, and overall language appropriateness.
Subject Matter Expert (SME) Reviews
While translators are linguistic experts, they may not be practising clinicians. Comms Multilingual bridges this gap by working with a network of clinical professionals, I/O psychologists, and consultants across multiple countries. These bilingual SMEs ensure that terminology, phrasing, and concepts are clinically appropriate and meaningful to the intended end user.
Read more about our SME translation review services here.
Cognitive Debriefing
Cognitive Debriefing is an important part of the whole Linguistic Validation process. In addition to expert linguistic review, Comms Multilingual offers cognitive debriefing services across a wide range of languages as a key component of linguistic validation.
What is Cognitive Debriefing?
Cognitive debriefing involves testing the translated version of a psychometric or clinical instrument with a small sample of representatives from the target population. The objective is to identify any issues related to comprehension, interpretation, or cultural relevance.
A qualified psychologist or consultant in the target country is provided with:
- The original source-language version
- The translated version
- Concept definitions and supporting documentation
Participants are guided through the instrument, and their understanding of each item is explored. Comms Multilingual then prepares a detailed cognitive debriefing report summarising findings and recommending revisions where necessary. These recommendations are reviewed collaboratively with the instrument developer and translation team before finalisation.
Why is Cognitive Debriefing Important?
Cognitive debriefing confirms that the translated content is understood by respondents in the same way as the source text. While linguistic validation typically involves multiple specialist linguists, certain nuances or ambiguities may only emerge when the instrument is tested with real respondents from the target population.
This step is therefore critical for identifying issues that may not be apparent through linguistic review alone and supports the validity of pooled or cross-cultural data in clinical trials.
What is a Good Cognitive Debriefing Sample Size?
A appropriate sample size depends on several factors, including:
- The complexity and nuance of the instrument
- The diversity of the target population
- The prevalence of the relevant condition or characteristic in the target country or region.
As a general guideline, a sample size of 5-8 participants is typically considered sufficient, with adjustments made based on project-specific requirements. Sample size justification is documented on a project-specific basis in accordance with best practice guidance.
If you’re working to tight timelines, we can help you plan and deliver a regulatory-ready linguistic validation workflow – from translatability assessment through to cognitive debriefing and final reporting. Submit a no-obligation quote request using the form below, or contact us to discuss your project.
