Hello,
I included SDTMIG 3.4 new SV domain variables SVPRESP, SVOCCUR, SVREASOC, SVCNTMOD, SVEPCHGI in the SV domain, which used the older version SDTMIG 3.3 version, and received an error message “SD0058: Variable appears in dataset, but is not in SDTM model”.
Should I stick with older version SDTMIG 3.3 and move these variables to SUPPSV domain or ignore the error message?
Best Regards,
Linda
@Linda_Li Below is a list of the “standard” variables as defined by each SDTMIG version:
| SDTMIG 3.3 | SDTMIG 3.4 |
|---|---|
| STUDYID | STUDYID |
| DOMAIN | DOMAIN |
| USUBJID | USUBJID |
| VISITNUM | VISITNUM |
| VISIT | VISIT |
| VISITDY | SVPRESP |
| SVSTDTC | SVOCCUR |
| SVENDTC | SVREASOC |
| SVSTDY | SVCNTMOD |
| SVENDY | SVEPCHGI |
| SVUPDES | VISITDY |
| SVSTDTC | |
| SVENDTC | |
| SVSTDY | |
| SVENDY | |
| SVUPDES |
It seems that SD0058 (Variable appears in dataset, but is not in SDTM model) is firing because you are validating a SDTMIG 3.4 compliant sv.xpt dataset against the SDTMIG 3.3 standard. Is that an accurate statement? If so, I want to ask why you are continuing to use SDTMIG 3.3 to validate and not upgrading to SDTMIG 3.4.
If you want to continue using SDTMIG 3.3, then those variables are not supposed to be a part of the SV domain. You could consider moving them into SUPPSV, but that feels like a lot more work than just updating the standard you are using for validation. 
Hi Trevor,
Thank you for sharing your insights! We will make the decision accordingly.
Best regards,
Linda
Hi Linda,
Even though you are using SDTMIG 3.3 and those SV variables (SVPRESP, SVOCCUR, etc.) aren’t part of that version, as per FDA they need to be included in the parent domain not SUPPSV.
This is mentioned clearly in the FDA’s Technical Conformance Guide and COVID-19 guidance. Please see below:
“SV Domain (Subject Visits)
It is the current preference of the Agency that for all clinical studies, subject visit data for
scheduled (whether or not they occurred), and unscheduled visits be submitted in one single dataset structured as the current CDISC Subject Visits (SV) domain. It is also Agency preference that three non-standard variables (NSVs) for missed visits, – REASOC (Reason for Occur Value), --EPCHGI (Epi/Pandemic Related Change Indicator), and --CNTMOD (Contact Mode), outlined in the CDISC property “Guidance for Ongoing Studies Disrupted by COVID-19 Pandemic” be included within the SV domain and not within the supplemental SUPPSV domain or in other SDTM datasets. Submitting subject visits information in one single structured dataset allows both the human and technology consumer of this information to operate efficiently and with confidence that all visit data are considered during regulatory review.”
So, no need to move them to SUPPSV or switch to SDTMIG 3.4 just for this—just include them in SV and document it.
Hope that helps!
Best Regards
Srigowri
Hi Srigowri,
Thank you so much for sharing!
Best regards,
Linda