If we are creating Customized domain can we add our own variables as per data?

  Hi! No you cannot do

Hi!

No you cannot do this. 

SDTM IG v.3.1.2 section 8.4 (p. 260):

"The SDTM does not allow the addition of new variables. Therefore, the Supplemental Qualifiers special purpose dataset model is used to capture non-standard variables and their association to parent records in general-observation-class datasets (Events, Findings, Interventions) and Demographics. Supplemental Qualifiers may be represented as either a single SUPPQUAL dataset per study or via separate SUPP-- datasets for each dataset containing sponsor-defined variables (see Section 8.4.2 for more on this topic)."

Regards, 

Sergiy

Thank you for the reply (Can i create custom domain or not)

Mean I should not create custom doamin or custom  variables in custom doamin. For example in my CRRF page for pharmaco kinetics I hav only date of collection and since it's phaseII I considered that as intervention and created XB domain . Is that appropriate or do need to follow some other . Please let me know.....

  In this particular case,

In this particular case, the date of PK sample collection on CRF will be used in PC domain if needed (if PC results do not include collection dates). Otherwise those data can be considered as data management information (used for cleaning PK Concentration results), are redundant to PK Conc. results and are not needed to be mapped into SDTM data as a separate entity.

Regarding your initial question, I would like to repeat, that according the SDTM standard you can not create custom variables.

The only thing you can do is to add SDTM variable to standard domains if needed and there are no special exclusion for your case in SDTM IG. 

Thank you for your help

Thank you ...:-)