TI and TV domains

Pinnacle 21 Support SDTM
1

Hi Justin,

Formally, you need to have TV and TI domains in submission SDTM data package.

According to FDA Study Data Technical Conformance Guide, “Unless a simplified ts.xpt is indicated, all TDM datasets should be included with each SDTM study submission to describe the planned conduct of a clinical study.”. It includes TV and TI domains.

There are no special P21 rules for TV and TI domains due to low utilization of these domains in review and analysis of study data in practice. For example, I do not know any tool which uses TV or TI domain.

Kind Regards,
Sergiy

2

I noticed, when I run P21 validation, that I don’t get issues if TI and TV domains are not included. Does that means that those domains are not mandatory? I always thought that we had to create TS, TA, TE, TI, and TV for a submission study.