Definition

Data relating to patient health and/or delivery of care routinely collected from sources such as electronic health records, claims, registries, or wearables (FDA RWE Framework).

Example

Hospital EHR data used to assess drug exposure and outcomes in a safety study.

Regulatory source

FDA RWE Framework 2018–2023, EMA RWD/RWE reflection paper

Common mistakes

Treating all RWD as equivalent quality without assessing fitness for use.

Inspector question

How do you use RWD in your PV activities and how do you assure quality?

Related terms