Translation and linguistic validation

Roundpeg adheres to the ISPOR-recommended translation methodology, which is in accordance with FDA and EMEA regulatory guidance, and includes:

 

  • Concept elaboration
  • Forward translation
  • Reconciliation
  • Back translation
  • Back translation review
  • Developer review
  • International harmonization
  • Cognitive debriefing
  • Double proof reading

 

Roundpeg has extensive experience in the translation and linguistic validation of a wide variety of PRO instruments, including measures of symptom, quality of life, functional status and patient satisfaction and patient diaries. We have produced translations for use in over 60 countries and are constantly developing links with new investigators to broaden this further.

We have been involved in the development of some high-profile translation guidelines (see Wild et al, 2005) and are continuously monitoring and refining the cognitive debriefing process to minimise the burden on the patient and thus enhance the quality of the data generated.