Dataset requirement for UK and EU [Regulatives / Guidelines]

posted by jag009  – NJ, 2026-05-18 08:23 (31 d 15:38 ago) – Posting: # 24624
Views: 1,102

Hi,

Does anyone know if CDISC dataset format (STDM and ADAM) is required for submission to UK and EU? I google searched and the answer was it is not required but recommended by UK and EU so to streamline and accelerate the regulatory review process. I know it's required by FDA.

If not CDISC, what dataset format is required by UK and EU?

Thx
J

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