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​The concept of linguistic validation (LV) has become quite popular in the process of clinical trials. Its popularity is linked to the history of epidemics, which necessitated the development of immunizations and vaccines.

Tackling these epidemics is a long, complex process during which medical and language professionals, and patients are involved. This is where linguistic validation comes in.


What is Linguistic Validation?


LV is an active process of testing the translation on target population in their own language. It originates from the medical branch of clinical research and is coupled with the application of linguistic expertise aimed at proving the quality of the medical documents before they are used on patients or on their behalf.


How Does It Work?


This process enables an in-depth investigation of the accuracy and reliability of these translations in the target language by the target population. It begins with the development of patient questionnaires, and carries on to the translation, revision, and proofreading steps. Once these are completed, the validation process starts.

LV puts to test the dichotomy between language and culture. The translation validation process is patient centered. It focuses on data accuracy and on the instrument’s conceptual equivalence in the target population.

This is because real-life concepts that are true and common in a given geographical location are not necessarily so on the other side of the planet. For that reason, LV questions every aspect of the medical language by testing the translated questionnaires to validate conceptual equivalence and content validity against patient-reported outcomes (PROs).


The Cognitive Debriefing (CD) Step


The involvement of patients necessitates another process called cognitive debriefing (or cognitive debriefing interview). This is a form of interview process, during which a linguist asks questions to a patient to determine to what extent they understand the translation.

Cognitive debriefing doesn’t conclude the process. However, during the interview, the linguist takes notes, requests alternatives to ununderstood concepts, and implements the suggestions with the translation Project Manager. This back-translation process also involves clients and instrument developers to accommodate shared knowledge by the project team.


Overview of the LV Process


The linguistic validation process involves the following steps from start to finish, in ascending order:


Forward Translation (FT)


This is the initial stage of the translation process whereby a medical translator produces a written translation in the target language. In the linguistic validation process, it is essential that the translator has specializes in and has experience in the medical field. This is because we are validating a medical instrument and the expected results must be as impeccable as possible.

During the forward translation process, two or multiple independent linguists perform the translation of the questionnaires to be validated and pass the documents on to the next step. Sometimes their role doesn’t end there because they can be consulted about their expertise to validate the quality of their work.




The reconciliation step consists in comparing the two (or multiple) versions of the translation to determine which is more accurate. The linguist who assumes this role applies their discretion and expertise to decide on what aspects to keep, remove, and improve.


Back-Translation (BT)


Once the reconciliation is complete, the instruments are passed on to independent linguists (different than before) for an extra appraisal. This step consists in translating the instruments back to the original language to determine how close they sound to the source texts. To ensure that there is no bias, linguists do not consult one another, and back-translators have no access to the source document.


Translation Review (TR)


After the above preliminary steps are completed, then comes the time for reviewing the translations. This step is performed by independent professional reviewers who launch a multilevel validation process by analyzing and comparing the forward and back-translation results. Once a decision is reached, the Project Manager, who also moderates the process, puts together a pre-final questionnaire for the next step.


Cognitive Debriefing (CD)


Also known as cognitive debriefing interviews, this step is designed for testing the translations on the target population to determine the level of their understandability and accuracy. As a part of the project team, a CD linguist—who must be in the target country and native speaker of the target language—selects the required number of patients who will participate in the clinical research by answering the questions contained in the questionnaire.

Once selected and approved by the project team lead, the patients answer the questions through the guidance and supervision of the linguist who specializes in the medical translation. The linguist collects the answers in the target language, takes note of the discrepancies, requests alternatives, and retranslates the answers back to the source language.

At this stage, discrepancies necessitate additional retranslation and validation steps, as many times as needed. After this step is submitted to the Project Manager, all aspects and discrepancies are analyzed by the head linguist (or validator) to make sure that all inconsistencies are addressed. With the rest of the project team, the Project Manager sorts out the best versions of the translation and launches the final reviews.


Final Check (FC)


Given the multiple translation and validation steps and an in-depth analysis, subsequent reviews and final checks are designed to make sure that the final product is accurate enough. It can be compared to the proofreading of the final translation in normal circumstances.

Any discrepancies, if any, are addressed at this stage. The discrepancies range from grammatical issues such as typographic errors to formatting. The final review step concludes the linguistic validation process.


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