SD0057 SDTM Expected variable EXDOSE not found

s Saurabh

on June 27, 2016

Hello,

Currently dosing information collected in text form. we are unable to derive EXDOSE(numeric amount of dose) from current data.

According to IG 3.2 EXDOSTXT: "Amount of EXTRT when non-numeric. Dosing amounts or a range of dosing information collected in text form. Example: 200-400. Not populated when EXDOSE is populated". So Dose Description mapped to EXDOSTXT variable and EXDOSE doesn't derive in SDTM EX data set.

But SD0057 rule generates warning, SDTM Expected variable EXDOSE not found.

Do we need to derive EXDOSE with EXDOSTXT? or Should SD0057 validation rule give some exemption for EXDOSE variable when EXDOSTXT variable present in SDTM EX?

Thanks,

Saurabh

Forums: SDTM

j Jozef

on June 28, 2016

SD0057 SDTM Expected variable EXDOSE not found

You cannot populate EXDOSE correctly using SAS-XPT in your case as it is a numeric field. You are also not allowed to impute EXDOSE from EXDOSTXT when it is a text.
I don't know how rule SD0057 has been implemented. You can try having a look at the "CDISC validation rules repository" to find out, but this states already for a number of months now: "This page is being redesigned and updated with latest validation rules. Please check back later".

s Sergiy

on June 28, 2016

Hi Saurabh, …

Hi Saurabh,

You need to create an empty EXDOSE variable in addition to EXDOSTXT.

In SDTM model, all Expected variables in standard domains should be created. However values in Expected variables may be missing for all records.

Kind Regards,

Sergiy

s Saurabh

on June 28, 2016

Hi Sergiy

Thank you Sergiy!! I understand website is under construction. Is it possible to add search option in to forum? It will be really helpful to find answers.

Regards,

Saurabh

s Sergiy

on June 28, 2016