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 TRANSLATION OF RESEARCH-RELATED MATERIALS: INSTRUCTIONS, DIARIES, CONSENT FORMS
In addition to patient-reported outcome (PRO) measures, high quality translation
of other research-related materials has become essential to the successful completion of
international multicenter clinical trials. These materials include instructions to patients
and/or study participants, patient diaries, consent forms for participation in research, and
protocols for clinical trials or research studies. These materials differ from PROs in that
they are not validated instruments for the collection of psychometric data. However, they are
all intended to be read and understood by research participants and therefore require a certain
level of rigor in the process by which they are translated. While we do not require the full
FACIT translation methodology for these instruments, we do take a systematic approach to their
translation so that minimal requirements for validity will be met.
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