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FACIT
Functional Assessment of Chronic Illness Therapy
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.