Page History

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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 1, Demographics

For a complete list of the variable labels, definitions and/or notes in the sections above, see Section 7 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 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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