Definition

Use of NLP to extract structured safety information from free text (narratives, literature, social media) for case processing or signal detection.

Example

NLP to identify drug name, reaction, and outcome from unstructured source documents.

Regulatory source

EMA/HTA workshop on RWD, FDA Sentinel NLP use cases

Common mistakes

Using NLP output without human verification for regulatory reporting.

Inspector question

How do you validate and control NLP-derived data used in ICSRs?

Related terms