CDISC SDTM standard

Inline with the Critical Path Initiative CDISC has developed three main standards to improve the efficiency of clinical trial projects, namely : Operational Data Model (ODM), the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM).

The SDTM defines a standard structure for study data tabulations. These are to be submitted as part of a product application to a regulatory authority such as FDA.

The SDTM was prepared by the CDISC Submission Data Standards (SDS) Team to guide the organization, structure, and format of tabulation data sets for study data submitted to regulatory authorities. Data tabulation data sets are one of four ways to represent the human subject Case Report Tabulation (CRT) and equivalent animal data submitted to the FDA.

The SDTM is composed of 30+ defined domains within six broad categories. Each domain represents a file structure and contains a particular type of data associated with clinical trials, such as demographics, vital signs or adverse events.

The model also provides the ability to create custom-defined domains with sets of standard variable definitions. Variables in common across domains all have similar name extensions, and the standard specifies the beginning prefix of all variables be a (typically) two-letter domain abbreviation.

We will come back with a discussion on how to interface your CDM system to produce SDTM files.

CDISC discussion forums : http://www.cdisc.org/discussions/discussions.html