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Translating Clinical Trial Outcomes Measures

An overview

Sergiy Tyupa, Diane Wild

Data di pubblicazione: 10/2016

ISBN: 9788897419716

Formato: 12,7 x 19,1 cm

Pagine: 86

In english

The purpose of this book is to provide a general overview of the translation and cultural adaptation process of clinical research survey instruments with a focus on the linguistic aspects of the process. Survey instruments here refer to any text, printed or electronic, prepared in order to collect information in a clinical research setting. This broad definition covers patient-reported, clinician-reported, and caregiver-reported outcomes measures, as well as patient diaries, indexes, scales, symptom checklists, etc. The first part of the book offers a brief introduction to selected linguistic aspects of translation in order to provide definitions of key linguistic concepts and to set a tentative theoretical framework for the translation and cultural adaptation process. The second part describes the main steps used in the translation process. The discussion of each step includes the definition of its most important component, a list of key professional involved in implementing the step, a detailed critical description of the process involved in the implementation of the step, as well as a brief overview of areas where more research is needed. The last chapters cover the translation of electronic versions of clinical research survey instruments, with a brief discussion of the necessary modification of each step in order to meet the needs of an electronic instrument translation.


Translation agencies, Contract Research Organization (CRO), Manager of the Pharmaceutical Industry; Physician and Medical Students

€ 14,99

Sergiy Tyupa
Professional medical translator and expert in translation and linguistic validation of PRO and QoL measures. Assistant Professor at Jagiellonian University in Krakow, Poland

Diane Wild
Independent PRO and linguistic validation consultant, UK

  • Introduction
  • Section I. Linguistic Aspects of Translation
    • Key terms and definitions
    • Selected areas of linguistic research
  • Section II. Translation and Cultural Adaptation Process
    • Preparation
    • Forward translation
    • Back Translation
    • Cognitive Debriefing
    • Check, Revision, Review and Proofreading
    • Translation of Electronic Versions

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