Refining Patient Reported Outcomes
White Paper: Conceptualizing Modifications & Identifying Validation Procedures for PRO Instruments, August, 2006
Summary
Clinical researchers are challenged by the FDA's reference to evaluating modified PRO tools as if they were newly developed instruments (Draft PRO Guidance for Industry, Federal Register, Vol. 71, No. 23; Friday, Feb. 3, 2006; Lines 178-179). The primary goals of this paper are to assist researchers as they conceptualize the level of modification they make to their existing PRO instruments and identify the procedures that may be necessary to validate that change.
Download "Conceptualizing Modifications & Identifying Validation Procedures for PRO Instruments"