TA Specification — This is a spreadsheet that provides information, for newer and proposed domains and variables, on their relationships with versions of SDTM and the SDTMIG.
TA Specifications were developed to assist FDA in their testing processes, but can also provide implementers with advice on how to adapt the representation of data shown in the TAUG to different versions of the standards. TA Specifications are provided as a resource to reviewers; we are not seeking comment on the TA Specification. However, we would appreciate being informed of inconsistencies in the content of the TA Specification and the TA User Guide.
This is a DRAFT standard, which means that it is still in development and not yet ready for provisional or general use.