The SDTM has been designed for backward compatibility; datasets prepared with prior versions should be compatible with v2.1. In most cases, this means that later versions may add new variables or correct textual errors, but do not eliminate variables or structures incorporated in prior versions. There are, however, isolated instances where some older variables may be deprecated in favor of newer, more functional variables. SDTM v2.1 does not include any proposed deprecated variables.

The following new section was added:

For a complete list of new variables,  changes to variable labels, definitions and/or notes and to other textual changes see Section 7, Changes from SDTM v2.0 to SDTM v2.1.

A number of changes had been proposed during development of the prior version of SDTM (Version 2.0). These same changes remain proposed for the next version of the SDTM. See Section 8, Proposed Future Changes to the SDTM, for the rationale for those proposed future changes.

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