Definition

Use of real-world data (e.g., claims, EHR, registries) to evaluate or validate safety signals, estimate rates, or assess confounders.

Example

Using Sentinel or similar to assess background rates and disproportionality.

Regulatory source

EMA RWE paper, FDA Sentinel

Common mistakes

Using RWD without protocol or predefined analysis plan.

Inspector question

Describe a signal evaluation where you used RWD and the methodology.

Related terms