Definition

Assessment of whether a given RWD source is adequate for the intended PV or safety question (completeness, accuracy, relevance, timeliness).

Example

Evaluating if a claims database has sufficient drug exposure and outcome capture for a specific AE.

Regulatory source

EMA RWD/RWE reflection paper, FDA RWE guidance

Common mistakes

Using convenience datasets without documented fitness-for-use assessment.

Inspector question

How do you document fitness for use of RWD in your analyses?

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