Is it mandatory to include all data collected into SDTM datasets?

s Shiming

on April 13, 2023

I have a study with data collected with duplicated information. Is it mandatory to include all of the collected data in SDTM different domains even if they are duplicated?

Forums: SDTM

j Jozef

on April 13, 2023

Is it mandatory to include all data collected into SDTM datasets

Yes.

SDTM is about categorization of data + some derivation + some assignments + some postprocessing data.
Some data indeed appears more than once in the datasets, e.g. visit date if no exact time of the measurements was collected.
Unfortunately, SDTM has evolved more and more to contain masses of amounts of redundant information for sake of "ease of review".

There are a few exceptions of collected data that do not go into SDTM, such as for "did any adverse events occur". AEs only go into SDTM if they occurred.

Not a bad idea to take an SDTM course from CDISC to learn more ...

Sergiy

on April 14, 2023

P21

Hi Shiming, Some examples…

Hi Shiming,

Some examples would be helpful to understand your case.

In general, SDTM Model has dedicated buckets for specific type of information. Storing duplicated information in different domains does not look right.

No, it’s not mandatory to include all the collected data in SDTM. Jozef provided such example. CRFs or Lab Results transfer files may include other data management or operational data with no clinical meaning for review and analysis.

Kind Regards,
Sergiy