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In SDTMIG v3.4 and SDTM v2.0, formats for Date/Time variables are now specified as "ISO 8601 datetime or interval." You may ask “What's that interval format and when would I use it?”

When an implementer is working how to represent data for a study, they first consult the SDTMIG and SDTM to find the appropriate standard variable. If no appropriate standard variable is found, the SDTMIG directs them to create a supplemental qualifier, also called a non-standard variable.

In an events or interventions domain, the variable --PRESP = "Y" can be used to indicate that the value in the topic variable (--TERM or --TRT) was pre-specified. However, --PRESP is not a variable that is allowed in findings domains.