Linguistic Validation

Linguistic Validation is a highly technical procedure involving a series of complex steps.

The goal of linguistic validation is to adapt clinical outcome materials for participants of a clinical study to ensure appropriate and accurate data collection.

What is Linguistic Validation?

Linguistic Validation is a highly technical procedure involving a series of complex steps, including forward translation, back translation, localization, and field testing of linguistically adapted documents.

The goal of linguistic validation is to adapt clinical outcome materials for participants of a clinical study to ensure appropriate and accurate data collection. This process is an absolute requirement in the administration of patient reported outcomes and patient questionnaires. It is generally part of larger clinical trial translation projects.

Learn More About Linguistic Validation Services:

Linguistic Validation - When Do You Need Linguistic Validation
When Do You Need Linguistic Validation

Linguistic Validation is usually required for international clinical trials where participants don’t speak English, or clinical trials being performed in the U.S. involving multiple language groups.

Texts subject to linguistic validation are usually Clinical Outcome Assessments – both paper and eCOAs – including:

  • Patient Reported Outcomes (PRO)
  • Clinician-Reported Outcomes (ClinRO)
  • Observer-Reported Outcomes (ObsRO)

A Quality of Life (QoL) Questionnaire is an example of a document that often undergoes linguistic validation.

Linguistic Validation - The Linguistic Validation Process
The Linguistic Validation Process

Linguistic Validation follows a relatively strict order, generally following 7 steps:

  • Translation and Localization

    All source documents are translated and localized by different teams of professional translators.

  • Reconciliation

    The translations developed by the different teams are reconciled into one document containing the “best” translation from each team.

  • Back Translation

    The reconciled translations undergo back translation to ensure the original meaning has not been lost. This is performed by a different set of native speaking translators who have not seen the original source documents before.

  • Editing

    Reconciled translations approved through back translation are then reviewed by project managers and clients, and approved for testing.

    If the PROs are electronic, software testing is performed to ensure that all language versions line up in the electronic data collection system.

  • Cognitive Debriefing

    Translations are used in cognitive debriefing interviews.

    This involves testing of the translated documents by patients from the target demographic (or at times by clinicians familiar with the target population).

    Upon completion of the test questionnaire, patients report their level of understanding of the document in question, and explain to researchers what they believe certain words and concepts mean.

  • Review

    Adjustments are made based on the results of the cognitive debriefing and further translation and back translation is performed if necessary.

  • Final Preparation

    The final document is prepared based on the adjustments made after cognitive debriefing interviews.

It is important to note that the process of translation and back translation is sometimes called linguistic validation.

Not all clients require that documents undergo cognitive debriefing interviews; though it is considered to be best practice.

Linguistic Validation - Why Perform Linguistic Validation
Why Perform Linguistic Validation

Linguistic Validation is a rigorous and time consuming process; however, there are two main reasons why it should be performed for clinical trial documentation:

  • 1. It satisfies FDA regulations concerning content validity between source documents & translated versions.
  • 2. It ensures that researchers can accurately compare qualitative data gleaned from trials performed across diverse linguistic & cultural groups. This allows for more precise conclusions.

Ensuring your documents have been translated and localized for the language and culture of the target patients also helps decrease patient confusion, and increase patient-physician communication. This in turn leads to better treatment options for individuals in the long run.

WHY PERFORM COGNITIVE DEBRIEFING?

The testing portion of linguistic validation is one of the most important aspects of the whole process.

Its aim is to identify whether or not the language of the source document has been translated in such a way as to yield conceptual and construct value equivalence (as outlined by the ISPOR PRO Task force) across all target language groups.

In other words:

The testing checks for correctness and consistency across languages which will allow participants to understand the documents with ease, and place similar values on certain outcome measurements across different cultures.

It also allows researchers to accurately compare results from all subjects participating.

The testing is necessary in that it reveals problems with the translated documents that are either subjective to patients, or are the result of errors in the source document or language used in translation.

Addressing these issues must be done in order to harmonize documents across all languages.

Linguistic Validation - Language Connections' Linguistic Validation
Linguistic Validation Solutions

Language Connections has extensive experience providing language solutions to pharmaceutical and medical device companies, as well as CROs.

Our approach to linguistic validation is one of the utmost precision, and done in accordance with best practices outlined by the FDA, ISPOR, and other regulatory bodies.

We adhere to a strict quality control process with all of our translations.

Our translation network covers over 100 of the world’s major languages, and spans the globe.

This enables us to provide scalable translation and testing solutions, and assemble highly skilled and professional teams for our clients.

When handling projects, we ensure:

  • The use of native speaking linguists and editors for your target language
  • Linguists with experience translating for the Life Sciences and Clinical fields
  • A dedicated project manager who will act as a liaison between clients and translators, and review documents

Depending on your specific needs, we assemble teams of translators for preliminary forward translation and reconciliation, as well as separate teams for back translation.

All translations are adjusted after cognitive debriefing interviews, based on the results of the testing.

VALIDATION SERVICES

If so required, we are also able to provide “validators” who are native speakers of your target languages, for the testing of the preliminary documents.

However, cognitive debriefing and testing is best done with individuals who fit the target demographics of your patient population.

Not all clients require cognitive debriefing and simply need forward and back translations according to company procedural standards.

We provide these services, and are able to assign third party translators to review a translation to ensure it has all the critical elements as defined by the client.

When Do You Need Linguistic Validation?

Linguistic Validation is usually required for international clinical trials where participants don’t speak English, or clinical trials being performed in the U.S. involving multiple language groups.

Texts subject to linguistic validation are usually Clinical Outcome Assessments – both paper and eCOAs – including:

  • Patient Reported Outcomes (PRO)
  • Clinician-Reported Outcomes (ClinRO)
  • Observer-Reported Outcomes (ObsRO)

A Quality of Life (QoL) Questionnaire is an example of a document that often undergoes linguistic validation.

Read our Case Study on e-clinical translation for CRS (now known as:   )

The Standard Process for Linguistic Validation

Linguistic Validation follows a relatively strict order, generally following 7 steps:

  • Translation and Localization

    All source documents are translated and localized by different teams of professional translators.

  • Reconcilization

    The translations developed by the different teams are reconciled into one document containing the “best” translation from each team.

  • Back Translation

    The reconciled translations undergo back translation to ensure the original meaning has not been lost. This is performed by a different set of native speaking translators who have not seen the original source documents before.

  • Editing

    Reconciled translations approved through back translation are then reviewed by project managers and clients, and approved for testing. If the PROs are electronic, software testing is performed to ensure that all language versions line up in the electronic data collection system.

  • Cognitive Debriefing

    Translations are used in cognitive debriefing interviews. This involves testing of the translated documents by patients from the target demographic (or at times by clinicians familiar with the target population). Upon completion of the test questionnaire, patients report their level of understanding of the document in question, and explain to researchers what they believe certain words and concepts mean.

  • Review

    Adjustments are made based on the results of the cognitive debriefing and further translation and back translation is performed if necessary.

  • Final Preparation

    The final document is prepared based on the adjustments made after cognitive debriefing interviews..

It is important to note that the process of translation and back translation is sometimes called linguistic validation. Not all clients require that documents undergo cognitive debriefing interviews; though it is considered to be best practice.

Why Perform Linguistic Validation?

Linguistic Validation is a rigorous and time consuming process; however, there are two main reasons why it should be performed for clinical trial documentation:

  • 1. It satisfies FDA regulations concerning content validity between source documents & translated versions.
  • 2. It ensures that researchers can accurately compare qualitative data gleaned from trials performed across diverse linguistic & cultural groups. This allows for more precise conclusions.

Ensuring your documents have been translated and localized for the language and culture of the target patients also helps decrease patient confusion, and increase patient-physician communication. This in turn leads to better treatment options for individuals in the long run.

Why Perform Cognitive Debriefing?

The testing portion of linguistic validation is one of the most important aspects of the whole process. Its aim is to identify whether or not the language of the source document has been translated in such a way as to yield conceptual and construct value equivalence (as outlined by the ISPOR PRO Task force) across all target language groups.

In other words:

The testing checks for correctness and consistency across languages which will allow participants to understand the documents with ease, and place similar values on certain outcome measurements across different cultures.

It also allows researchers to accurately compare results from all subjects participating.

The testing is necessary in that it reveals problems with the translated documents that are either subjective to patients, or are the result of errors in the source document or language used in translation. Addressing these issues must be done in order to harmonize documents across all languages.

Linguistic Validation Solutions

Language Connections has extensive experience providing language solutions to pharmaceutical and medical device companies, as well as CROs. Our approach to linguistic validation is one of the utmost precision, and done in accordance with best practices outlined by the FDA, ISPOR, and other regulatory bodies. We adhere to a strict quality control process with all of our translations.

Our translation network covers over 100 of the world’s major languages, and spans the globe. This enables us to provide scalable translation and testing solutions, and assemble highly skilled and professional teams for our clients.

When handling projects, we ensure:

  • The use of native speaking linguists and editors for your target language
  • Linguists with experience translating for the Life Sciences and Clinical fields
  • A dedicated project manager who will act as a liaison between clients and translators, and review documents

Depending on your specific needs, we assemble teams of translators for preliminary forward translation and reconciliation, as well as separate teams for back translation. All translations are adjusted after cognitive debriefing interviews, based on the results of the testing.

Validation Services

If so required, we are also able to provide “validators” who are native speakers of your target languages, for the testing of the preliminary documents. However, cognitive debriefing and testing is best done with individuals who fit the target demographics of your patient population.

Not all clients require cognitive debriefing and simply need forward and back translations according to company procedural standards. We provide these services, and are able to assign third party translators to review a translation to ensure it has all the critical elements as defined by the client.

NEED MORE INFORMATION FOR YOUR LINGUISTIC VALIDATION PROJECT?

U.S.  Environmental Protection Agency Logo
Alere
ABT Associates
CHDI Foundation
AstraZeneca
PAREXEL
Pathfinder
Genzyme
Ecron Acunova
MannKind Corp.
Keystone Human Services