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Process for linguistic validation of PRO instruments


STEP 1
Concept Elaboration

  • Project and process plan
  • Evaluation of source instrument for translatability and target group
  • Translation guides, style guides and briefing
  • Team establishment


STEP 2
Forward Translation and Reconciliation

  • Two forward translations of the source instrument by two independent specialist medical translators
  • Reconciliation and finalisation by a third specialist translator to form a single version


STEP 3
Back-Translation and Harmonisation

  • Back-translation by a specialist medical translator with no knowledge of the source text
  • Review of the back-translation
  • Comparison between the back-translation and the source document and, if necessary
    corrections of the forward translation
  • Harmonisation of all translation languages based on the back-translations and the original
    instrument and, if necessary, correction/harmonisation of the forward translations


STEP 4
Cognitive Debriefing

  • Creation of the project-specific debriefing protocol
  • Debriefing interviews conducted by a professional medical team with 5–10 patients in 3 steps (details of the
    questionnaire, comprehensibility or interpretation by patients, suggestions for changes by patients)


STEP 5
Creation of the Final Version

  • Analysis of cognitive debriefing results
  • Review or revision of the instrument
  • Creation of the final version
  • Proofreading – final approval taking into account all requirements


STEP 6
Final Report


You can select a complete package for linguistic validation of the PRO instrument or just select individual steps.



Your expert for linguistic validation of PRO instruments


CONDUCT CLINICAL TRIALS IN GLOBAL MARKETS SEAMLESSLY.

Because clinical trials are increasingly being conducted at an international level, there is also a growing need for translation and cultural adaptation of patient reported outcome (PRO) measures and for linguistic validation of the PRO instruments.  


A patient reported outcome (PRO) is a measurement of any aspect of a patient’s health status that is reported directly by the patient, without a clinician or other third party interpreting the information.

Important

It is therefore absolutely essential that the translations, cultural adaptations and harmonisations of the questionnaires/instruments used are accurate as well as being culturally and conceptually equivalent to the source instrument and are written in patients’ national languages.

Translation and linguistic validation of PRO instruments is a very complex process that ultimately aims to create a comprehensive picture of a medicinal product’s therapeutic effects.

Right from the first steps of the linguistic validation, we will help you to develop strategies for PRO instrument validation that satisfy regulatory and budgetary requirements. You will receive reliable PRO instruments which guarantee the successful implementation of your global studies.

PRO + LINGUISTIC VALIDATION – OUR NETWORK – YOUR SUCCESS

Our global network of linguistic validators and medical translators, subject matter experts, doctors, psychologists and in-country reviewers allows us to expedite each linguistic validation project while retaining scientific accuracy.

Each project is also linguistically equivalent across all languages, instilling confidence that the data can be pooled for statistical analysis.



Quality standard of the mpü process for linguistic validation of PRO instruments


By focusing on translating documentation for all globally active companies and CROs, we have honed our expertise in translating and harmonising PRO instruments for use in both paper and electronic formats.  

Our state-of-the-art linguistic validation process ensures both precise and timely completion of your documents/instruments.

Our process for linguistic validation is modelled on the U.S. Food and Drug Administration (FDA) PRO guidance document as well as the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and European Medicines Agency (EMA) GCP guidelines.

Our experience in translating PRO instruments is constantly expanding and now covers a range of therapeutic areas including rheumatology, oncology, neurology, gastroenterology, geriatrics, gynaecology and so on