SD1087 rule for SE domain

Pinnacle 21 Support SDTM
1

Hi Barry,

Requirements for population of Study Days in addition to Date/Time variables are from FDA rather than from CDISC SDTM IG.

See recent FDA’s “STUDY DATA TECHNICAL CONFORMANCE GUIDE”

http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM384744.pdf

On page 9:

". Whenever --DTC, --STDTC or --ENDTC are included, the matching Study Day variables (–DY, --STDY, or—ENDY, respectively) should be included. For example, in most Findings domains, --DTC is Expected, which means that --DY

should also be included. In the Subject Elements domain, SESTDTC is Required and SEENDTC is Expected; therefore, both SESTDY and SEENDY should be included."

Kind Regards,

Sergiy

2

I have a comment about rule SD1087 being used to check the SE domain. Based on my understanding of the SDTM IG, I don’t believe this rule should be applied to SE data because SE is a special-purpose domain. From my understanding, additional timing variables cannot be added to the SE variable list, just as additional variables cannot be added to the DM domain.