Version 1.5 of SDTM specifically supports SENDIG v3.1 and contains the following new variables to support SEND that will not be used in human clinical trials: --USCHFL, --DTHREL, --EXCLFL, --REASEX, FETUSID, --NOMDY, --NOMLBL, EXMETHOD, ICIMPLBL.
SDTM v1.5 includes content that is more broadly applicable to the SDTM family of implementation guides, such as:
- Text corrections and clarifications.
- It introduces the concept of domain specific variables. These are variables for use only in a specific domain.
- New tables to relay data about disease milestones at the subject and trial level and domain-specific variables.
- New variables have been added to the general observation class tables.
Details of these additions can be found in section 7 of the document.
A future version of the SDTMIG will be published that incorporates variables found in SDTM v1.5 however, sponsors cannot use the new domain variables in a conformant manner until that future version of SDTMIG is finally published.
The use of any content in SDTM v1.5 is for SEND implementation only. The use of SDTM v1.5 content for human clinical trials needs to be carefully considered. It would not be valid to use new variables found SDTM v1.5 with any previously published implementation guide. Each implementation guide specifies the version of the SDTM that it is associated with. For example, any domains developed from SDTMIG v3.2 would fail conformance checks if they utilized new variables found in SDTM v1.5. The only valid way to include these variables in a human clinical trial would be to use them as supplemental qualifiers. If one is using a supplemental qualifier that contains content appropriate for one of the new variables, it may be better to give that supplemental qualifier the name of the new variable, rather than some other name.