ISPOR
Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures
Foundational good practice recommendations for the translation and cultural adaptation of PRO measures.
Resources
Practical guidance, methodologies and educational resources for the linguistic validation and cultural adaptation of Clinical Outcome Assessments (COAs) across languages, countries and patient populations.
Linguistic validation is designed to support conceptual equivalence, cultural appropriateness and comprehension of translated COAs while preserving the concepts measured by the source instrument. The appropriate methodology may vary according to the type of instrument, target population, available translations, target countries, developer and copyright holder requirements, intended mode of administration and other factors.
Our resources explore the linguistic validation pathway, from translatability assessment and concept elaboration through translation or adaptation, reconciliation, back translation, review, recruitment, clinician review, cognitive debriefing and final linguistic quality review.
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Guide
Understand the stages commonly used to develop conceptually equivalent and culturally appropriate COA translations, from preparation and forward translation through reconciliation, back translation, review, cognitive debriefing and finalisation.
Explore the Linguistic Validation Guide →
Guide
Understand the role of Cognitive Debriefing in Linguistic Validation, including when it may be required, participant selection and recruitment, what happens during interviews, how participant feedback is evaluated and how findings may inform the final validated translation.
Explore the Cognitive Debriefing Guide →
Linguistic Validation Case Study
See how NN Translations coordinated a multi-country linguistic validation project involving specialised linguists, linguistic validation consultants (LVCs), target population participants while maintaining conceptual equivalence and documented traceability across languages.
Read the Linguistic Validation Case Study →
Our Support
We support clinical trial sponsors, CROs, COA licensing companies and eCOA providers across the linguistic validation pathway, from early translatability and translation planning through cultural adaptation, clinician review, cognitive debriefing and final linguistic quality review.
Depending on the instrument, target population and project requirements, the methodology may include Translatability Assessment, Concept Elaboration, dual Forward Translation, Reconciliation, Back Translation, Back Translation Review, Developer Review, Clinician Review, Cognitive Debriefing, External Review, Proofreading, Final Quality Check and more.
Where an authorised validated translation already exists, we can support country-specific adaptation rather than developing a new translation from the source.
Linguistic Validation Project Qualification Questionnaire
Captures instrument details, target population, languages and countries, existing validated translations, required methodology, developer requirements, timelines and deliverables.
Linguistic Validation Workflow Overview
Provides clients with an overview of the validation stages, responsibilities, review points and deliverables.
Linguistic Validation FAQ Guide
Answers common questions about methodology, timelines, linguistic validation consultants, clinician review, cognitive debriefing, documentation and deliverables.
Additional Project Resources
Further supporting materials and project documentation are available to prospective and existing clients upon request, depending on project requirements.
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Reference Library
ISPOR
Foundational good practice recommendations for the translation and cultural adaptation of PRO measures.
ISPOR
Good practice recommendations addressing language selection, country-specific language versions and multilingual data pooling in multinational trials.
ISOQOL
Good-practice recommendations for the translation, cultural adaptation and Linguistic Validation of ClinRO, ObsRO and PerfO measures.
FDA
FDA guidance addressing the development and use of PRO measures to support medical product labelling claims.
EMA
EMA reflection paper addressing the use of HRQL measures in the evaluation of medicinal products.
Contact us at any stage of your study or COA planning. Share the information currently available, such as the COA or instrument list, target population, countries and languages, existing translations, planned mode of administration and expected study timeline, and we can help determine the appropriate Linguistic Validation pathway.
We can also assist with COA Planning & Consulting, COA Licensing & Management, and subsequent eCOA Migration & Support, helping connect the different stages of the COA pathway.