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:
- Section 6.8 Related References Dataset
Two new variables, restricted in use to the Tobacco Implementation Guide, have been added to the following sections:
- Section 3.1.4 Identifiers for All Classes
- GNTXAID
- SPTOBID
The existing variable, SETCD, was also added to the Section 3.1.3 The Findings Observation Class.
A number of variable labels, variable definitions, and notes associated with variables have been changed in the following sections:
- Section 3.1.1 The Interventions Observation Class
- Section 3.1.2 The Events Observation Class
- Section 3.1.3 The Findings Observation Class
- Section 3.1.5 Timing Variables for All Classes
- Section 3.2.1 Demographics
For a complete list of the variable labels, definitions and/or notes in the sections above, see Section 7 Changes from SDTM v2.0 to SDTM v2.1.
A number of specific textual changes have been made throughout this version. For a complete list of the textual changes made, 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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