Linguistic Validation

Translation and Linguistic Validation are two related methodologies but have distinctly different scopes, processes, outcomes and uses.

Linguistic Validation consists of Translation and Cognitive Debriefing.  Cognitive Debriefing is the “validation” part of the Linguistic Validation process.  If Cognitive Debriefing doesn’t take place, the translation is not linguistically validated; it’s just a translation.

Scope:

Translation focuses on accurately conveying content from one language to another, while Linguistic Validation includes translation but also addresses cultural relevance, understanding, and equivalence across languages.

Process:

Translation typically involves one or two translators and possibly a reviewer. Linguistic Validation involves multiple steps, including translation, back-translation, linguistic and expert review, and cognitive debriefing with target responders.

Outcome:

The outcome of translation is a text that accurately reflects the source material in another language. The outcome of linguistic validation is a culturally and linguistically adapted, comparable/equivalent text–though the wording or parts of the content may differ from source–that is understood in the same way by its target language groups.

Use:

Translation is used for a wide range of documents, including manuals, training content, information booklets, and textbooks. Linguistic Validation is mostly used in the Life Sciences industry, where it’s crucial that instruments like clinical outcomes measures work consistently the same way across different languages and cultures, despite their unique syntax and grammatical structures, and behavioural norms. Linguistic Validation is also used in Academia, e-Learning and Aerospace industries, and in global Marketing and Advertising brand campaigns.

Artificial Intelligence (AI) can assist parts of the linguistic validation process, but it cannot replace the clinical, cultural, or psychometric expertise required to make defensible adaptations. At Santium, AI is used selectively and only in ways that support—not substitute—expert judgment.

WHERE AI IS NOT USED

We do not use AI or MT engines for forward translation, item adaptation, or stylistic editing. These steps require clinical reasoning, cultural sensitivity, and construct-level decision-making that AI cannot (yet) reliably perform.  We continue to test AI outputs to evaluate how its ability is evolving.

RESPONSIBLE USE OF AI

AI tools may be used for:

• Generating rough backward translations for early-phase quality checks
• Comparison analyses to quickly flag mistranslations, shifts in meaning, etc.
• Pattern-based review checks (e.g., terminology drift, inconsistent phrasing)

In all cases, AI output is treated strictly as a diagnostic aid, never as a replacement for human translation or validation.

Linguistic validation helps verify that translated clinical instruments function equivalently across languages and cultures. AI cannot evaluate cultural relevance, respondent burden, construct drift, or measurement implications. Human oversight remains essential to safeguard conceptual integrity and regulatory defensibility.

None.

The 2009 Patient-Reported Outcome (PRO) Guidance for Industry, issued by the U.S. Food and Drug Administration (FDA) only briefly touches on the importance of translation and cultural adaptation when patient-reported outcomes measures are used in international clinical trials.

The guidance is primarily focused on ensuring the reliability and validity of PRO measures. Although the guidance is specific to PROs, its content can be readily applied to any type of a clinical outcomes measure (e.g., ClinROs).

Not including a translation methodology in the PRO guidance was intentional, for two key reasons:

1. FDA chose not to limit researchers to a single prescribed method of translation. This is fact: we were part of the working group!

2. The industry was in the process of testing a linguistic validation method developed by a working group representing the International Society for Pharmacoeconomic and Research Outcomes (ISPOR), published it in 2005 (Wild et al., 2005), and at the time still in its infancy stage of adoption.  This ISPOR-developed method eventually became the gold standard that is now known and accepted throughout the industry. This is fact: we were also part of this working group!

FDA’s decision not to prescribe a translation method has had a dual effect across the Life Sciences industry: 

1. Cognitive debriefing is often omitted from “linguistic validation” projects, mainly due to longer project timelines that are necessary to complete the pilot test. Therefore, a very high percentage of translations used in clinical trials are not linguistically validated.

2. Technological advances in the translation industry made certain steps in the methodology, including its variations, redundant and unnecessary.

After more than 15 years of selective application, the linguistic validation method is due for a practical revision that must include processes for adapting untranslatable content.

Not true.  This is sometimes only an unfortunate internal policy. Let’s review what translation equivalency actually means.

Translation equivalency refers to the degree to which a translated content accurately reflects the meaning, intent, and impact of the original source text while being culturally appropriate and understandable in the target language.

Given the prescribed meaning and purpose of “translation equivalency”, the wording of items in an outcomes measure, or a survey, may have to change to accurately convey a particular concept to the target responder, especially when the chosen sample of the measured concept is not specifically relevant to the target responder, or to the context of the responder’s culture or environment.

In some cases, the concept may not exist in the target country altogether, or may only be applicable to other types of responders.

Therefore, when translating clinical outcomes measures, translators and study project managers must unlearn this misconstrued resistance to adapting psychometric instruments.

It will be crucial to validate the translation, at least via thorough cognitive debriefing, before using it in its intended context.

If a user’s manual or any form of instruction accompanies the instrument, or survey, ensure that changes made in the questionnaire(s) are reflected in the administration instructions, including screenshots of sample scoring forms, demo items, etc..

That depends on the nature of the change.  Validity can be preserved after adaptation, if changes to source text are done by someone qualified to make that kind of a change.

For example, translators are not qualified to make such changes to COAs. They can, and do, make recommendations, particularly during the translatability assessment stage, which is designed to shed light on content that will need adaptation.

However, the onus to provide clear and accurate instructions on what to change and how to do it, including any necessary training for the translator(s), lies with the party assigning the job to the translator.  It is never the translator’s job to “figure it out”.  Translators don’t have the appropriate training for modifying source text in clinical outcome measures, regardless how experienced they may be in translation or transcreation.

The validity of a rating scale refers to how well the scale measures what it is intended to measure. Therefore, from a psychometric standpoint, replacing and rewording items is an essential part of preserving the translated instrument’s validity.

A translated clinical outcome measure, even when flawlessly translated to mirror the original source, can instantly lose its validity when some or more of its items are not relevant to the target language speakers and their culture.

For example, items that measure stigmatized concepts, verbal fluency, adaptive behaviours, language development milestones, house chores, or country-specific knowledge across tiered age groups, just to name a few.

Whenever changing source text becomes necessary, it’s critically important to revalidate the scale to ensure that it still measures the intended construct validly and reliably.

More often than not, it’s the author’s representative or agent, or internal policies governing the representative or agent, that doesn’t allow for the changes to be made; not the author.

If the author psychometrically validated the instrument, the author will understand the need for the change, assuming that you have a valid argument to support the change. Also, the author must know that only a qualified individual, or a group, will be making the change. 

If you have a strong case, the author will either make the changes for you, or will allow you to make changes to source text within specific parameters and/or with the author’s guidance.  

Depending on the nature of the change, you may also need to adjust the scoring algorithm.

If the author, or the author’s representative or agent, refuse(s) to allow you to change source text even when you provide a solid argument for the change, your project or study may be better off with another instrument in its assessment schedule lineup.

Linguistic validation consists of translation and cognitive debriefing. If cognitive debriefing doesn’t take place, then it’s just a translation that is not linguistically validated.

The cost is built on the number of steps that are necessary to validate the translation.  For a brand new translation, there are at least 2 full translations of the same document, plus at least 2 content reviews and editing.

Therefore, linguistically validated translations are more expensive than a classic translation from Language A to Language B.

Things to consider:

• Is linguistic validation necessary for the document you wish to have translated?

• Do you wish to start with an existing translation?

• Is the existing translation accompanied with a translation certificate that outlines its translation methodology?

• How long is the document?

• Are there any other documents that are dependent on the one that needs validation (e.g., administration and scoring instructions, visual aids, etc.)?
• Who is the target audience for cognitive debriefing?

• Have you allocated adequate time for cognitive debriefing?

The best way to get an accurate price for your translation project is to complete our Request for Quote form. Contact us and we will email it to you.

Once you submit it, we will provide you with a free quote with no obligations.