About Linguistic Validation
Below are many common questions you may have about linguistic validation. We provide you with
answers to these questions, and other important reasons to conduct a linguistic validation.
What is a linguistic validation? Why conduct a linguistic validation? How do you conduct a linguistic validation?
In order to answer the question, How long does it take to complete a linguistic validation?, we need more information about your study. We have a few questions that we need to ask you in order to provide you with a quotation.
Upon receipt of this information we can provide you with a proposal and a quotation within 24 to 48 hours.
What is a Linguistic Validation?
Linguistic validation is a process that establishes objective evidence that ensures that the outcomes being evaluated by patients in the target audience are functionally equivalent to those in the source audience.
Why Do a Linguistic Validation?
Questionnaires yield data for approval of efficacy and safety of new drugs by the EMA and FDA. Translations from many countries must be functionally equivalent so that data can be pooled for a single statistical analysis.
What is "pooling"?
Pooling is gathering small sets of data that are assumed to have the same value (e.g., mean) of a characteristic and using the combined larger set - the "pool" - to obtain a more precise estimate of that characteristic.
The Source is the Problem
In most cases the source content is not written for a global audience. The content is usually in some variety of English that contains implicit Western values and concepts that are not universal. Many questionnaires are full of medical jargon and English idioms. In some instances, the only solution is to change the source to make the content more culturally relevant.
Concept Definition
Conceptual equivalence is about how people interpret objects, stimuli and behaviors in their culture and environment. The developer is responsible to provide a Concept Definition Document as a part of the documentation in developing the questionnaire. This information is provided to the translators and to the linguist who conducts the interviews.
Translation Process
The process is usually segmented into two major activities, Translation and Linguistic Validation. All steps in our process are documented in our standard operating procedures (SOPS). There are many checks and balances in the process. Before a translation is considered to be final, it is tested with the target audience. This phase is referred to as the linguistic validation.
Planning and Kickoff
We develop a project plan that includes Translation Guidelines, Concept Definition Document, the key milestones and specification of deliverables. These are reviewed with the sponsor at a kickoff meeting to be sure roles and responsibilities and lines of communication are defined.
Interviews with Patients
Several individuals in the target audience who speak the target language are interviewed individually by one of our professional linguists. Sometimes referred to as cognitive debriefing, the draft translation of the questionnaire is evaluated to verify how the questions, instructions, and concepts are understood. Special attention is given to the primary outcomes and to the scales. The goal of the interviews is to make sure that individuals in the target language understand the translated content in a manner that is functionally equivalent to similar individuals reading the source content.
Forward Translation and Reconciliation
Two translators work independently to translate the the source content into the target language. A third linguist then reconciles the two forward translations with the source and creates a consensus translation in the target language and culture.
Proofing and Final Review
After completing the interviews, all recommended changes must be checked to be sure that they conform to the Translation Guidelines and are harmonized across all languages in the project. Each document is proofed and checked to be sure that it is free from errors and that it is formatted correctly. Since the translations for most languages are longer than the English source, proofing of the final formatted translation is critical, especially for electronic devices that have space limitations. All translations are certified that they meet the highest quality standards and meet regulatory requirements.
Back Translation and Review
The consensus translation is then back translated by another translator into the source language. The project manager compares the back translation with the source version to be sure that all concepts, scales, outcomes, and instructions are functionally equivalent to the source.
How Long Does It Take
We can complete most full translations and linguistic validations in three weeks, anywhere in the world. Projects that involve data collection on an electronic device may take a little longer. Other factors such as the involvement of the developer or sponsor, the number of questionnaires, and if the problem is a rare disease, may also affect the time required to complete a project. During times when unexpected events may occur, such as COVID-19, local disasters, and individual emergencies, the timing may need to be extended. To the extent possible, these events are included in the project timeline.
Want to Learn More About How We Can Help
with Your Next Linguistic Validation?
We will provide you with guidance about the questionnaires that are most appropriate to meet your study objectives. Our linguistic validation experience and clinical knowledge can help you plan, design, and execute your clinical trial, or outcomes study in an optimal way. We can insure that the data collected will be functionally equivalent so that the data can be pooled from all countries for a single statistical analysis.