— Translation and linguistic validation of patient
reported outcomes instruments
— Qualitative research
> personal interviews
> focus groups
— Guidance in choice of patient reported
outcomes instruments
— Distribution of validated patient
reported outcomes instruments (HAQ,
WOMAC, AUSCAN, et. al.)
— Development of new global patient
reported outcomes instruments
— Evaluation of adequacy of study design
— Statistical plan and analysis of PRO data
— Preparation of dossiers for regulatory
agencies
— Printing and shipping of case report forms