Chapter 1: Overview of Real-World Data

Assessing Fitness for Purpose

The research team should assess whether the target data set (including the data source, any linkages that may be performed, and the subsequent data operations on the combined data set) is aligned with the principles of “fit-for-purpose” data as outlined in this resource: “Characterizing RWD Quality and Relevancy for Regulatory Purposes.”18 The Structured Process to Identify Fit-For-Purpose Data (SPIFD) provides a systematic process for conducting feasibility assessments that can be used to evaluate whether a data source is fit for decision making, and for documenting the rationale for selected data sources.19