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When it comes to setting up a foundation for diverse, patient-centric clinical trials, linguistic validation is an essential localization practice that can help prepare patient questionnaires for participants in diverse global regions, an essential to succeeding in the age of eClinical trial automation. With new FDA guidelines released to encourage diversification in drug development, the pressure is now on to ensure every arm of your pharmaceutical operations can quickly and effectively incorporate worldwide participant data. What is more, and what linguistic validation ensures, is that to truly reflect the goals of patient-centric trials, the reporting mechanisms offered to participants – namely, clinical outcome assessments and eCOAs – must be intuitive and guide them to report accurately on their experiences and symptoms, without any possibility of misunderstanding. Fortunately, by using back-translation processes that retranslate the localized version of a questionnaire into the original source language, and by applying strict translation management practices, language service providers can give sponsors and CROs complete assurance that their content deploys to all individuals participating in their trial with equal assurance of accuracy.

Linguistic Validation: An Essential Aspect of Preparing Patient Questionnaires for Global Clinical Trials

Localizing patient questionnaires to communicate with participants in different regions is more than just good practice.  With the FDA’s new guidelines on encouraging diversity in drug development, some have speculated that scrutiny over diversity clinical trials may soon lead to denials for approval, noting the importance of demonstrating a structured approach to expanding the trial population for those filing a New Drug Application (NDA), in particular. For new trials, it is only going to become more important to incorporate reliable, worldwide participant data, and the quality of that reporting is a direct consequence of the quality of the translations provided to patients.

One of the key components of patient-centric trials is the reporting mechanisms offered to participants. For eClinical practices, digitalized eCOAs introduce benefits of automation for both participants and sponsors, but in turn raise the requirements for localization measurably. By utilizing linguistic validation and by providing software localization testing where needed to ensure forms work in every language and across devices, language service providers can help prevent costly errors that impact participants and ultimately prevent them from reporting timely and accurate data.

How Linguistic Validation Works

As we explain in our in-depth review of what to know about linguistic validation, the focus of this process is to ensure the quality of eClinical measurements through a series of steps that test the quality of a translated instrument. Those steps are:

  • Dual Forward Translation
  • Harmonization
  • Back Translation
  • Clinical Review
  • Cognitive Debriefing

By leveraging an expert linguist to evaluate initial translation by two separate linguists with in-field subject matter expertise, Dual Forward Translation and Harmonization result in a single target-language version of the eCOA. To validate that result, the target language version then undergoes Back Translation by a linguist who specializes in translation from the target language (as an expert linguist) into the source language (as a native speaker and subject matter expert). During Clinical Review, this result is reviewed by a medical professional side-by-side with the original source eCOA. Finally, Cognitive Debriefing involves presenting the harmonized forward-translation to native speakers of the target language, which can provide final feedback on the cultural navigability of the content.

How CSOFT Health Sciences Helps

As well as accuracy, factors like cultural sensitivity place a strong emphasis on the quality of human linguistic translation services a localization provider can offer to sponsors and CROs in eClinical scenarios. By working with language service providers that specialize in this process, sponsors and CROs can ensure that their clinical trial materials are accessible to all individuals, regardless of their language or cultural background. With a global network of medical translators in hundreds of languages, certified translation management and quality assurance processes, and a readiness to work with all file types and formats, CSOFT is well equipped to help drug developers reach decentralized trial populations worldwide in a timely manner while maximizing the benefits of the eClinical approach at the level of patient communications. To learn more about our services, visit us at