Dating rules to my future self wiki
Generally speaking, from the industry side, it is not considered valuable to provide custom domains, given the issues with nonstandardized data (nonstandard format; can't use across organizations, etc.).
The Study Data Standards page provides current expectations/recommendations.
For data submissions, please create TS according to the IG you use.
Is the file for studies that start before 2016-12-17 required beginning on 2016-12-17?
30 days after publish on the FDA Study Data Standards page. Just TSPARMCD=STSTDTC is explicitly required (for legacy studies under covered study types, e.g., single dose, carc, etc.). There are new variables added in the base SDTM after the SENDIG was published.
Will FDA accept submissions with these not included?
There is no requirement to retroactively update past studies with CT that comes out after finalization. For an endpoint to be required, it must meet two criteria to be considered mandatory for FDA submissions: However, this is purely speaking to what is mandatory.