Definition

A set of clinical data standards that support consistent submission and analysis, commonly including SDTM and ADaM.

Example

Designing CRF fields to support cleaner SDTM mapping (e.g., clear units, dates, and controlled terms).

Regulatory source

Common submission standard expectations by many regulators.

Common mistakes

Treating standards as only a programming concern; collection design strongly affects downstream mapping quality.

Inspector question

How do you collaborate with programming to ensure CRF design supports standards-based deliverables?

Related terms