SDTM v 1.8 Warning

*The use of any content in SDTM v1.8 is for SEND implementation only. The use of SDTM v1.8 content for human clinical trials needs to be carefully considered. It would not be valid to use new variables found SDTM v1.8 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 v1.8. 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.