SDTM v2.0


Published Date:

Version 2.0 of the Study Data Tabulation Model (SDTM) describes the general conceptual model for representing clinical study data. It is intended for companies and individuals involved in the collection, preparation, and analysis of study data that may be used for various purposes, including publication, warehousing, meta-analyses, and regulatory submission.

SDTM v2.0 is the first major release since the model's original publication in 2004. Changes that make SDTM v2.0 a major version include:

  • Updates to explanatory text, much of which was unchanged since the SDTM was first introduced.
  • Reorganization of some sections to clarify relationships between SDTM structures.
  • Additions to variable metadata, including the addition of variable definitions.

Variable Metadata

SDTM v2.0 represents variable metadata in a new structure, but meanings have not changed, except where new variables and domains have been introduced.

  • The same metadata is included in all tables to ensure consistency across tables.
  • Information previously represented in one metadata item has been pulled apart into separate items. For example, the "Role" metadata item is split into "Role" and "Variable(s) Qualified." The "Description" metadata item is split into "Definition," "Examples," and "Notes."
  • The new metadata item "Usage Restrictions" serves three purposes to indicate variables that are:
    • Restricted to certain domains.
    • Not allowed in certain domains or classes (e.g., --OCCUR is not allowed in the Adverse Events domain, --STDTC and --STDY are not allowed in findings class domains).
    • For use only in clinical trials or in non-clinical trials.

SDTM v2.0 also includes the addition of:

  • The RELSPEC domain
  • Several new variables
  • A new section to announce proposed future changes

Version 2.0 supersedes all prior versions of the SDTM. The SDTM has been designed for backward compatibility; datasets prepared with prior versions should be compatible with v2.0. Please visit Section 7.0 for an overview of all changes.

Public Review Comments

CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.


Files

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SDTMIG v3.4
SDTM and SDTMIG Conformance Rules v2.0

Errata

An erratum (plural: errata) is a correction to a mistake made in a published standard, which was identified after it was published on the CDISC website, and which would have been corrected in the current version had it been identified prior to publication. Updates, revisions, substantive corrections, and other changes of enough significance to require a cycle through the Standards Development Process are not errata, and thus are not included on the pages below.

Errors that Affect Conformance

An error that affects conformance is a correction to a mistake in the normative content of a CDISC standard, which was identified after the standard has been published on the CDISC website, and which would have been corrected in the current version had it been identified prior to publication. Corrections that require a cycle through the Standards Development Process are not considered errors that affect conformance. Corrections to errors that do not impact conformance to CDISC standards are listed as Errata.