Dataset requirement for UK and EU [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2026-05-18 10:25 (16 d 19:22 ago) – Posting: # 24625
Views: 649

Hi John,

❝ 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.

No idea about the UK, but for the EMA it’s still in the pilot phase. However, already mandatory in Denmark (see Ohlbe’s post).

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

Any. If you want to avoid time-consuming requests, keep it simple and avoid proprietary formats. A scanned PDF of a table of analytical results is not a good idea.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,653 posts in 4,991 threads, 1,571 registered users;
508 visitors (0 registered, 508 guests [including 27 identified bots]).
Forum time: 05:48 CEST (Europe/Vienna)

I’m all in favor of the democratic principle
that one idiot is as good as one genius, but I draw the line
when someone takes the next step and concludes
that two idiots are better than one genius.    Leo Szilard

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5