Purpose

This document describes the Study Data Tabulation Model (SDTM), which defines a standard structure for study data tabulations. This document, which supersedes all prior versions, includes numerous changes from the prior version (SDTM v2.0). These changes are described in Section 1.4, Significant Changes from Prior Versions, and Section 7, Changes from SDTM v2.0 to SDTM v2.1. 

This document 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. Guidance and specifications for the application of this model are provided separately in the implementation guides (IGs). Regulatory authorities provide separate guidance, specification, and regulations. Readers are advised to refer to these documents before preparing a regulatory submission based on the SDTM.