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.
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.
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:
A Quality of Life (QoL) Questionnaire is an example of a document that often undergoes linguistic validation.
Read our Case Study: Rare Language Translation and Linguistic Validation for Concordant Rater Systems
Linguistic Validation follows a relatively strict order, generally following 7 steps:
All source documents are translated and localized by different teams of professional translators.
The translations developed by the different teams are reconciled into one document containing the “best” translation from each team.
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.
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.
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.
Adjustments are made based on the results of the cognitive debriefing and further translation and back translation is performed if necessary.
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 is a rigorous and time consuming process; however, there are two main reasons why it should be performed for clinical trial documentation:
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.
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.
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:
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.
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.
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:
A Quality of Life (QoL) Questionnaire is an example of a document that often undergoes linguistic validation.
Read our Case Study: Rare Language Translation and Linguistic Validation for Concordant Rater Systems
Linguistic Validation follows a relatively strict order, generally following 7 steps:
All source documents are translated and localized by different teams of professional translators.
The translations developed by the different teams are reconciled into one document containing the “best” translation from each team.
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.
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.
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.
Adjustments are made based on the results of the cognitive debriefing and further translation and back translation is performed if necessary.
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 is a rigorous and time consuming process; however, there are two main reasons why it should be performed for clinical trial documentation:
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.
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.
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:
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.
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.
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:
A Quality of Life (QoL) Questionnaire is an example of a document that often undergoes linguistic validation.
Read our Case Study: Rare Language Translation and Linguistic Validation for Concordant Rater Systems
Linguistic Validation follows a relatively strict order, generally following 7 steps:
All source documents are translated and localized by different teams of professional translators.
The translations developed by the different teams are reconciled into one document containing the “best” translation from each team.
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.
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.
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.
Adjustments are made based on the results of the cognitive debriefing and further translation and back translation is performed if necessary.
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 is a rigorous and time consuming process; however, there are two main reasons why it should be performed for clinical trial documentation:
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.
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.
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:
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.
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.
About Language Connections:
Language Connections is one of the top language service companies in the US. Over the last 30 years, we’ve focused on providing the best business translation services, interpreting services, as well as interpreter training and customized language training programs. In addition to top-tier corporate language training, we offer certified corporate interpreters and professional business translation services in 200+ languages. Our network includes linguists with backgrounds in all major industries. They’re ready to meet your needs, whether they’re for technical translation services, legal translation, government translation services, international development translation services, education translation services, life sciences translation, or something else. Reach out to us today for a free quote on our cost-efficient and timely translation services, interpreters, or other linguistic services.
Language Connections Inc.
2001 Beacon Street, Suite 105,
Boston, MA 02135
Phone: +1-617-731-3510
Email: service@languageconnections.com
